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Sep 02, 2025｜2025
US Food and Drug Administration (FDA) Approves Henlius and Organon’s BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively

SHANGHAI, China & JERSEY CITY, NJ – September 2, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.1,2

 

“The FDA approvals of BILDYOS and BILPREVDA mark a significant step toward expanding access to critical bone care treatments needed by millions of people in the US, including a growing aging population.3,4,5 Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women,” said Jon Martin, US Commercial Lead, Biosimilars and General Medicines at Organon.3,4 “This approval underscores Organon’s unwavering commitment to making treatments more accessible while focusing on creating a more sustainable future for the care of bone health.”4,5,6  

 

BILDYOS is a RANK ligand (RANKL) inhibitor indicated for treatment of postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. See full indications below.

 

Patients with advanced kidney disease treated with BILDYOS are at greater risk of severe hypocalcemia. Severe hypocalcemia resulting in hospitalization, life-threatening events, and fatal cases have been reported with denosumab products. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. Prior to initiating BILDYOS in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with BILDYOS in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD. See additional safety information below.

 

BILPREVDA is a RANK ligand (RANKL) inhibitor indicated for the prevention of skeletal-related events in certain patients with multiple myeloma and bone metastases from solid tumors, giant cell tumor of bone, and hypercalcemia of malignancy. See full indications below.

 

Hypersensitivity reactions, including anaphylaxis, may occur with use of denosumab products, including BILPREVDA. Discontinue permanently if a clinically significant reaction occurs. Denosumab products can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Correct hypocalcemia prior to initiating BILPREVDA. Monitor calcium levels during therapy, especially in the first weeks of initiating therapy, and adequately supplement all patients with calcium and vitamin D. Osteonecrosis of the jaw (ONJ) has been reported in patients receiving denosumab products. Perform an oral examination prior to starting BILPREVDA. Monitor for symptoms. Avoid invasive dental procedures during treatment. Evaluate patients with thigh or groin pain to rule out a femoral fracture. When BILPREVDA treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures. BILPREVDA can cause fetal harm. Advise females of reproductive potential of potential risk to the fetus and to use effective contraception. See additional safety information below.

 

“The FDA approvals of BILDYOS and BILPREVDA mark another set of Henlius’ self-developed and self-manufactured biosimilars approved in the United States, underscoring our commitment to scientific excellence and consistent product quality,” said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. “We're proud to continue expanding access to quality biologics through the collaboration with Organon, delivering biosimilar treatment options that are as safe and effective as the reference biologics to more patients across the US.”5,7,8

 

BILDYOS and BILPREVDA were approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and a comparative clinical study demonstrating that BILDYOS and BILPREVDA are highly similar to and have no clinically meaningful differences to their reference products, PROLIA and XGEVA, respectively, in terms of safety, purity, and potency.8,9

 

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including BILDYOS and BILPREVDA. The agreement covers exclusive global commercialization rights except for China.10

 

“These approvals are a testament to the strong collaboration between Henlius and Organon to expand patient access to quality and potentially more affordable biosimilars,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius.4,5,8 “Together, we are working to broaden access to important treatment options and better meet the needs of both patients and providers in the US.”5

 

BILDYOS and BILPREVDA join Organon’s biosimilars portfolio in the US, which has been growing for over eight years and spans five major therapeutic areas.11-14 This milestone reflects Organon’s long-standing commitment to expanding access to quality, cost-effective treatments and to advancing women’s health through a sustainable, patient-centered approach.5,7,8


References

1. PROLIA. Prescribing Information. Amgen Inc.; 2025.

2. XGEVA. Prescribing Information. Amgen Inc.; 2025.

3. Office of Women’s Health. Osteoporosis. US Food and Drug Administration. May 13, 2024. Accessed December 4, 2024. http://www.fda.gov/consumers/womens-health-topics/osteoporosis

4. Biosimilars in the United States: providing more patients greater access to lifesaving medicines. Biosimilars Council. 2017. Accessed July 25, 2025. http://biosimilarscouncil.org/wp-content/uploads/2019/03/Biosimilars-Council-Patient-Access-Study.pdf

5. Overview for health care professionals. US Food and Drug Administration. Updated August 1, 2024. Accessed March 13, 2025. http://www.fda.gov/drugs/biosimilars/overview-health-care-professionals

6. Aitken M, Kleinrock M, Pritchett J. Biosimilars in the United States 2023-2027: competition, savings, and sustainability. IQVIA Institute for Human Data Science. January 31, 2023. Accessed January 7, 2025.

7. Biosimilars basics for patients. US Food and Drug Administration. May 7, 2024. Accessed September 1, 2024. http://www.fda.gov/drugs/biosimilars/biosimilars-basics-patients

8. Review and approval. US Food and Drug Administration. December 13, 2022. Accessed July 28, 2025. http://www.fda.gov/drugs/biosimilars/review-and-approval

9. Biosimilar product regulatory review and approval. US Food and Drug Administration. Accessed May 1, 2025. http://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf

10. Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates. Organon. June 13, 2022. Accessed July 28, 2025. http://www.organon.com/news/organon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates/

11. HADLIMA. Prescribing Information. Organon; 2024.

12. ONTRUZANT. Prescribing Information. Organon; 2025.

13. RENFLEXIS. Prescribing Information. Organon; 2023.

14. TOFIDENCE. Prescribing Information. Organon; 2025.




About BILDYOS® (denosumab-nxxp)

BILDYOS is a RANK ligand (RANKL) inhibitor indicated for/to:


  • Postmenopausal Women with Osteoporosis at High Risk for Fracture: BILDYOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, BILDYOS reduces the incidence of vertebral, nonvertebral, and hip fractures.

  • Increase Bone Mass in Men with Osteoporosis: BILDYOS is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

  • Glucocorticoid-Induced Osteoporosis: BILDYOS is indicated for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least 6 months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

  • Bone Loss in Men Receiving Androgen Deprivation Therapy for Prostate Cancer: BILDYOS is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer. In these patients, denosumab products also reduced the incidence of vertebral fractures.

  • Bone Loss in Women Receiving Adjuvant Aromatase Inhibitor Therapy for Breast Cancer: BILDYOS is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.


SELECTED SAFETY INFORMATION


SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE
Patients with advanced chronic kidney disease (eGFR <30mL/min/1.73m2), including dialysis dependent patients, are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events, and fatal cases have been reported.


The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients.


Prior to initiating BILDYOS in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with BILDYOS in these patients should be supervised by a health care provider with expertise in the diagnosis and management of CKD-MBD.


CONTRAINDICATIONS


BILDYOS is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be corrected prior to initiating BILDYOS. BILDYOS is contraindicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman. In women of reproductive potential, pregnancy testing should be performed prior to initiating treatment with BILDYOS. BILDYOS is contraindicated in patients with a history of systemic hypersensitivity to any component of the product. Reactions have included anaphylaxis, facial swelling, and urticaria.


WARNINGS AND PRECAUTIONS


Severe Hypocalcemia and Mineral Metabolism Changes
 Denosumab products can cause severe hypocalcemia and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating therapy with BILDYOS. Adequately supplement all patients with calcium and vitamin D.


In patients without advanced chronic kidney disease who are predisposed to hypocalcemia and disturbances of mineral metabolism (eg, treatment with other calcium lowering drugs), assess serum calcium and mineral levels (phosphorus and magnesium) 10 to 14 days after BILYDOS injection.


Drug Products with Same Active Ingredient
 The active ingredient in BILDYOS is denosumab. Patients receiving BILDYOS should not receive other denosumab products concomitantly.


Hypersensitivity
 Clinically significant hypersensitivity, including anaphylaxis, has been reported with denosumab products. Symptoms have included hypotension, dyspnea, throat tightness, facial and upper airway edema, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of BILDYOS.


Osteonecrosis of the Jaw (ONJ)
 ONJ, which can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing. ONJ has been reported in patients receiving denosumab products. A routine oral exam should be performed by the prescriber prior to initiation of BILDYOS. A dental examination with appropriate preventive dentistry is recommended prior to treatment in patients with risk factors for ONJ such as invasive dental procedures (eg, tooth extraction, dental implants, oral surgery), diagnosis of cancer, concomitant therapies (eg, chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (eg, periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). Good oral hygiene practices should be maintained during treatment with BILDYOS. Concomitant administration of drugs associated with ONJ may increase the risk of developing ONJ. The risk of ONJ may increase with duration of exposure to denosumab products.


For patients requiring invasive dental procedures, clinical judgment of the treating physician and/or oral surgeon should guide the management plan of each patient based on individual benefit-risk assessment.


Patients who are suspected of having or who develop ONJ while on BILDYOS should receive care by a dentist or an oral surgeon. Extensive dental surgery to treat ONJ may exacerbate the condition. Discontinuation of BILDYOS should be considered based on individual benefit-risk assessment.


Atypical Subtrochanteric and Diaphyseal Femoral Fractures
 Atypical low-energy, or low trauma fractures of the shaft have been reported in patients receiving denosumab products. Causality has not been established as these fractures also occur in osteoporotic patients who have not been treated with antiresorptive agents.

During BILDYOS treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Interruption of BILDYOS therapy should be considered, pending a benefit-risk assessment, on an individual basis.


Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment
 Following discontinuation of denosumab treatment, fracture risk increases, including the risk of multiple vertebral fractures. New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of denosumab. Prior vertebral fracture was a predictor of multiple vertebral fractures after denosumab product discontinuation. Evaluate an individual’s benefit-risk before initiating treatment. If BILDYOS treatment is discontinued, patients should be transitioned to an alternative antiresorptive therapy.


Serious Infections
 In a clinical trial of over 7800 women with postmenopausal osteoporosis, serious infections leading to hospitalization were reported more frequently in the denosumab group than in the placebo group. Serious skin infections, as well as infections of the abdomen, urinary tract, and ear, were more frequent in patients treated with denosumab products. Endocarditis was also reported more frequently in denosumab-treated patients. The incidence of opportunistic infections and the overall incidence of infections were similar between the treatment groups. Advise patients to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis.


Patients on concomitant immunosuppressant agents or with impaired immune systems may be at increased risk for serious infections. Consider the benefit-risk profile in such patients before treating with BILDYOS. In patients who develop serious infections while on BILDYOS, prescribers should assess the need for continued BILDYOS therapy.


Dermatologic Adverse Reactions
 In a clinical trial of over 7800 women with postmenopausal osteoporosis, epidermal and dermal adverse events such as dermatitis, eczema, and rashes occurred at a significantly higher rate with denosumab treatment compared to placebo. Most of these events were not specific to the injection site. Consider discontinuing BILDYOS if severe symptoms develop.


Musculoskeletal Pain
 In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients during denosumab treatment. Onset of symptoms varied from one day to several months after starting denosumab products. Consider discontinuing use if severe symptoms develop.


Suppression of Bone Turnover
 In clinical trials in women with postmenopausal osteoporosis, treatment with denosumab resulted in significant suppression of bone remodeling as evidenced by markers of bone turnover and bone histomorphometry. The significance of these findings and the effect of long-term treatment with denosumab products are unknown. Monitor patients for consequences, including ONJ, atypical fractures, and delayed fracture healing.


Hypercalcemia in Pediatric Patients with Osteogenesis Imperfecta
 BILDYOS is not approved for use in pediatric patients. Hypercalcemia has been reported in pediatric patients with osteogenesis imperfecta treated with denosumab products.


ADVERSE REACTIONS

The most common adverse reactions (>5% and more common than placebo) reported with denosumab products in women with postmenopausal osteoporosis are back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.


The most common adverse reactions (>5% and more common than placebo) reported with denosumab products in men with osteoporosis are back pain, arthralgia, and nasopharyngitis. Pancreatitis has been reported with denosumab products.


The most common adverse reactions (>3% and more common than active-control group) reported with denosumab products in patients with glucocorticoid-induced osteoporosis are back pain, hypertension, bronchitis, and headache.


The most common (per patient incidence ≥10%) adverse  reactions reported with denosumab products in patients with bone loss  receiving androgen deprivation therapy for prostate cancer or adjuvant  aromatase inhibitor therapy for breast cancer are arthralgia and back pain.  Pain in extremity and musculoskeletal pain have also been reported in clinical  trials.


The most common adverse reactions leading to discontinuation of denosumab products in patients with postmenopausal osteoporosis are back pain and constipation.


Denosumab is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.


Before prescribing BILDYOS, please read the Prescribing Information (http://www.organon.com/product/usa/pi_circulars/b/bildyos/bildyos_pi.pdf), including the Boxed Warning about severe hypocalcemia. The Medication Guide (http://www.organon.com/product/usa/pi_circulars/b/bildyos/bildyos_mg.pdf) also is available.


Please note, BILDYOS is part of the Risk Evaluation and Mitigation Strategy (REMS) program.




About BILPREVDA® (denosumab-nxxp)

BILPREVDA is a RANK ligand (RANKL) inhibitor indicated for:


  • Multiple Myeloma and Bone Metastasis from Solid Tumors: BILPREVDA is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors.

  • Giant Cell Tumor of Bone: BILPREVDA is indicated for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

  • Hypercalcemia of Malignancy: BILPREVDA is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.


SELECTED SAFETY INFORMATION


CONTRAINDICATIONS


Pre-existing hypocalcemia must be corrected prior to initiating therapy with BILPREVDA. BILPREVDA is contraindicated in patients with known clinically significant hypersensitivity to denosumab products.


WARNINGS AND PRECAUTIONS


Drug Products with Same Active Ingredient
 Patients receiving BILPREVDA should not receive other denosumab products concomitantly.


Hypocalcemia
 Denosumab products can cause severe symptomatic hypocalcemia, and fatal cases have been reported. Pre-existing hypocalcemia must be corrected prior to initiating BILPREVDA. Monitor calcium levels throughout therapy, especially in the first weeks of initiating therapy, and administer calcium, magnesium, and vitamin D as necessary. Concomitant use of calcimimetics and other drugs that can lower calcium levels may worsen hypocalcemia risk, and serum calcium should be closely monitored. Advise patients to contact a health care provider for symptoms of hypocalcemia.


An increased risk of hypocalcemia has been observed in clinical trials of patients with increasing renal dysfunction, most commonly with severe dysfunction (creatinine clearance less than 30 mL/min and/or on dialysis), and with inadequate/no calcium supplementation. Monitor calcium levels and calcium and vitamin D intake.


Hypersensitivity
 BILPREVDA is contraindicated in patients with known clinically significant hypersensitivity to denosumab products, including anaphylaxis. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue BILPREVDA therapy permanently.


Osteonecrosis of the Jaw (ONJ)
 ONJ has been reported in patients receiving denosumab products, manifesting as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration, or gingival erosion. Persistent pain or slow healing of the mouth or jaw after dental surgery may also be manifestations of ONJ. In clinical trials in patients with cancer, the incidence of ONJ was higher with longer duration of exposure.


A history of tooth extraction, poor oral hygiene, or use of a dental appliance may be predisposing factors to developing ONJ. Other risk factors for the development of ONJ include immunosuppressive therapy, treatment with angiogenesis inhibitors, systemic corticosteroids, diabetes, and gingival infections.


Perform an oral examination and appropriate preventive dentistry prior to the initiation of BILPREVDA and periodically during therapy. Advise patients regarding oral hygiene practices. Avoid invasive dental procedures during treatment with BILPREVDA. Consider temporarily interrupting therapy if an invasive dental procedure must be performed.


Patients who are suspected of having or who develop ONJ while on BILPREVDA should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.


Atypical Subtrochanteric and Diaphyseal Femoral Fracture
 Atypical femoral fracture has been reported with denosumab products. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution.


Atypical femoral fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. A number of reports note that patients were also receiving treatment with glucocorticoids (eg, prednisone) at the time of fracture. During BILPREVDA treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Any patient who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of BILPREVDA therapy should be considered, pending a risk/benefit assessment, on an individual basis.


Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone (GCTB) and in Patients with Growing Skeletons

Clinically significant hypercalcemia requiring hospitalization and complicated by acute renal injury has been reported in denosumab-treated patients with GCTB and in patients with growing skeletons. Hypercalcemia has been reported within the first year after treatment discontinuation. After treatment is discontinued, monitor patients for signs and symptoms of hypercalcemia, assess serum calcium periodically, reevaluate the patients’ calcium and vitamin D supplementation, and treat appropriately.


Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation
 MVF have been reported following discontinuation of treatment with denosumab products. Patients at higher risk for MVF include those with risk factors for or a history of osteoporosis or prior fractures. When BILPREVDA treatment is discontinued, evaluate the individual patient’s risk for vertebral fractures.


Embryo-Fetal Toxicity
 Based on data from animal studies and its mechanism of actions, denosumab products can cause fetal harm when administered to a pregnant woman.


Verify the pregnancy status of females of reproductive potential prior to the initiation of BILPREVDA. Advise females of reproductive potential to use effective contraception during therapy, and for at least 5 months after the last dose of BILPREVDA. Advise pregnant women and females of reproductive potential that exposure to BILPREVDA during pregnancy or within 5 months prior to conception can result in fetal harm.


ADVERSE REACTIONS


The most common adverse reactions (incidence ≥25%) in patients with bone metastasis from solid tumors were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse reaction was dyspnea. The most common adverse reactions resulting in discontinuation were osteonecrosis and hypocalcemia.

The most common adverse reactions (incidence ≥10%) in patients with multiple myeloma were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache. The most common serious adverse reaction was pneumonia. The most common adverse reaction resulting in discontinuation was osteonecrosis of the jaw.


The most common adverse reactions (incidence ≥10%) in patients with GCTB were arthralgia, back pain, pain in extremity, fatigue, headache, nausea, nasopharyngitis, musculoskeletal pain, toothache, vomiting, hypophosphatemia, constipation, diarrhea, and cough. The most frequent serious adverse reactions were osteonecrosis of the jaw, bone giant cell tumor, anemia, pneumonia, and back pain. The most common adverse reaction resulting in discontinuation was osteonecrosis of the jaw.


The most common adverse reactions (incidence >20%) in patients with hypercalcemia of malignancy were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.


Before prescribing BILPREVDA, please read the Prescribing Information (http://www.organon.com/product/usa/pi_circulars/b/bilprevda/bilprevda_pi.pdf).



About Organon

Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.


Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn (http://www.linkedin.com/company/organon/), Instagram (http://www.instagram.com/organonllc/), X (http://x.com/OrganonLLC), YouTube (http://www.youtube.com/channel/UCFXZcWljXuEhDkMCmZZ4Yzw), TikTok (http://www.tiktok.com/@organon_llc) and Facebook .


Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about expectations regarding the business opportunities and prospects for BILDYOS and BILPREVDA. Forward-looking statements may be identified by words such as “will,” “potential,” “aim,” “explore,” “opportunity,” “expect,” “future,” “working to,” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, an inability to market BILDYOS and BILPREVDA; factors that could adversely affect the level of demand for BILDYOS and BILPREVDA (including trade protection measures and import or export licensing requirements; changes in US and foreign federal, state, and local governmental funding als, including the timing and amounts allocated to Organon’s customers and business partners; and economic factors); the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid, and health care reform, pharmaceutical reimbursement, and pricing in general; manufacturing difficulties or delays; restructurings or other disruptions at the FDA and other government agencies; efficacy, safety, or other quality concerns; and future actions of third-parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits, and forgoing health care insurance coverage. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings (including Organon’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025), available at the SEC’s Internet site (www.sec.gov). References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.


PROLIA and XGEVA are trademarks registered in the US by Amgen, Inc.; Organon is not associated with this trademark owner.



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Based on the context in which you interact with us, we may collect personal information by the following means and on the legal bases permitted by applicable PRC laws and regulations, including your consent, the necessity for entering into or performing a contract, compliance with legal obligations, protection of life, health or property, public health needs, or other circumstances permitted by law:

 

• Your personal information provided to us voluntarily

 

When you subscribe to our news or announcements, contact us through the contact details or other interactive features made available on our website, a third-party platform or service linked or referred to on our website, or otherwise communicate with us in relation to our website, we may collect the personal information that you voluntarily provide, such as your name, contact details, organization, and the content of your inquiry or request, depending on the relevant page or function.

 

• Personal information collected by us independently through our website and other online channels

 

When you visit our website, most of our services do not require any registration, and you can visit our website without telling us who you are. However, some pages or functions may require you to provide certain personal information. If you choose not provide such information as we request, you may not be able to access certain content or functions or we may not be able to respond to your inquiry, request or subscription. Please refer to the relevant page or notice for further details about the categories of personal information collected in a specific scenario.

 

• Personal information we collect from vendors or business partners

 

In the course of our daily business operations, we may collect personal information from our vendors or business partners. We require our vendors and business partners to comply with the requirements of the personal information protection laws and regulations of the PRC and to lawfully provide us with personal information. If you are an employee or representative of one of our vendors or business partners, we may collect personal information such as your name and contact details for the purpose of establishing business contacts and cooperations.

 

• Personal information we collect from publicly available sources

 

We may collect personal information of medical and healthcare professionals from such publicy available sources, such as the official websites of medical institutions and the official websites of competent government departments, and process such information within a reasonable scope and for lawful purposes. For example, for the purpose of lawful academic or professional interaction with healthcare professionals, we may collect the name, gender, employer, position, practitioner registration information, academic title, degree, educational background, specialty expertise, and profile information, where such information has been lawfully made public.

 

Our website may include links, contact details, QR codes, or references to third-party platforms or services. Where you choose to interact with us through such third-party platforms or services, the relevant third party may also process your personal information in accordance with its own privacy policy and applicable law, and we encourage you to review such policy before submitting your information.

 

II. How do we use your personal information?

 

We may use your personal information for the following purposes:

 

• Operating, maintaining and improving our website and other online resource;

 

• Researching, developing, providing and continuously improving our products and services;

 

• Conducting and managing daily business;

 

• Academic interaction with healthcare professionals;

 

• Responding to your inquiries, requests, or communications sent through our website or the contact details made available on our website;

 

• Providing subscription services for our news, announcements, or investor-related updates;

 

• Managing and maintaining our relationship and communications with business contacts who reach us through our website;

 

• Recruiting and human resource management;

 

• Internal compliance management，audit，record-keeping; and

 

• Complying with applicable PRC laws and regulations, for example, monitoring and reporting adverse events for purposes of performing drug quality management responsibilities, providing medical information and dealing with product complaints, etc..

 

We will process personal information only to the extent necessary for the relevant purpose. Where required by applicable law, we will obtain your consent or separate consent before processing your personal information or sensitive personal information. Where a third-party platform or service is used in connection with a particular function, the relevant third party may process your personal information in accordance with its own privacy policy and applicable law.

 

III. How do we entrust, share, transfer and publicly disclose your personal information?

 

1. Entrustment

 

We may entrust our business partners with the processing of your personal information for the purpose(s) described in this Policy. We will enter into appropriate confidentiality, data processing and security agreements with such entrusted parties and require them to process personal information in accordance with our instructions , this Policy and applicable PRC laws and regulations.

 

2. Sharing and public disclosure

 

For the purpose(s) described in this Policy, we will share or publicly disclose your personal information only where permitted by applicable PRC laws and regulations and, where required, after obtaining your consent or separate consent. Such circumstances may include:

 

• Sharing your personal information among our affiliates and subsidiaries where necessary for legitimate business, management, compliance, or operational purposes;

 

• Sharing your personal information with vendors or business partners (such as conference service providers, travel service providers, data service providers, banking or insurance institutions, other professional service organizations, to the extent necessary for the relevant purpose); and

 

• Disclosing your personal information to the extent that it is permitted or required by applicable PRC laws and regulations or for the purpose of assisting with investigations by judicial, regulatory or law enforcement authorities.

 

• other circumstances permitted by applicable PRC laws and regulations.

 

If you submit your information through or in connection with a third-party platform or service referred to on our website, the relevant third party may independently process your personal information in accordance with its own privacy policy and applicable law.

 

3. Transfer

 

We will not transfer your personal information to any other company, entity or individual unless otherwise permitted by applicable law and, where required, after obtaining your consent. Further, in the event of a merger, acquisition, insolvency, reorganization, division, dissolution, bankruptcy, or similar transaction, we will require the new processor of your personal information to continue to be bound by this Policy or we will require the new processor to obtain your consent again.

 

IV.How do we provide your personal information across borders?

 

In principle, personal information that we collect and generate in the course of our operations within the territory of the PRC will be stored within the PRC. In certain circumstances, it may be necessary for us to provide your personal information to recipients outside the PRC in connection with our business operations, website functions, or communications, where permitted by applicable PRC laws and regulations. As required by applicable laws and regulations regarding the protection of personal information, we will provide you with the required notice and obtain your separate consent before providing your personal information across any border, unless otherwise permitted by law. We will use lawful cross-border transfer mechanisms to transfer your personal information oversea and will take necessary measures to ensure that the oversea recipients provide a level of protection required by applicable PRC laws and regulations.

 

You may obtain more information about cross-border transfers of personal information and oversea recipients through the contact methods referred to in this Policy.

 

V. How do we store your personal information?

 

We will retain your personal information for the minimum period necessary to achieve the purposes described in this Policy ,unless a longer retention period is required or permitted by applicable PRC laws and regulations. Upon expiration of the applicable retention period, we will promptly delete or anonymize your personal information in accordance with applicable PRC laws and regulations. Our criteria for determining the period for which personal information shall be retained include:

 

• Applicable laws, regulations and other relevant requirements;

 

• The period of time needed for us to provide services, maintain business relations or interact with you; and

 

• The period of time needed for us to perform relevant agreements or fulfil the purposes described in this Policy.

 

VI. What security measures do we take to protect your personal information?

 

In accordance with applicable PRC laws, regulations, and the requirements of relevant national standards, we take reasonable and appropriate security and precautionary measures to protect the personal information we process against unauthorized access, public disclosure, use, modification, destruction or loss of data. However, you are also responsible for taking appropriate measures to protect the security of the devices, systems, and networks you use when accessing our website or communicating with us.

 

VII. Your rights 

 

In accordance with the requirements of the applicable PRC laws and regulations, you may have the following rights in respect of your personal information:

 

• To know about and make decisions regarding the processing of your personal information;

 

• To access or copy your personal information;

 

• To correct or supplement your personal information;

 

• To delete your personal information;

 

• To request for explanation of rules regarding processing of personal information; and

 

• To change the scope of your consent or revoke your consent , where processing is based on your consent.

 

If you wish to exercise your rights with respect to personal information, you may contact us through the contact information listed in this Policy and we will respond to any request in accordance with applicable relevant laws and regulations. When you exercise the above rights, we may verify your identity to safeguard the security of your personal information. Subject to applicable PRC laws and regulations, there may be circumstances where we are unable to respond to all or part of your request.

 

VIII. How do we process the personal information of minors?

 

For the purposes of this Policy and in accordance with applicable PRC laws and regulations, our products, websites and services are not targeted at minors under the age of 14. Minors under the age of 14 should not provide personal information to us without the consent of a parent or legal guardian.

 

If a minor's personal information is collected with the consent of a parent or legal guardian, we will process the information only when permitted by law, with the express consent of the parent or legal guardian, or necessary for the protection of the minor. If we discover that we have collected personal information without obtaining verifiable prior consent of a parent or legal guardian, we will seek to delete the data as soon as possible.

 

IX. Updates of the Policy

 

We may revise our Privacy Policy from time to time. We will post the updated version on our website and update the “Last Updated” date above or below this Policy.

 

Last updated: March 30, 2026.

 

X. How to contact us?

 

If you have any questions, comments or suggestions concerning this Policy, or any questions or concerns about our processing of your personal information, you may contact us in the following ways:

 

Address: 11/F, B8 Building, No.188 Yizhou Rd, Xuhui District, Shanghai

 

Tel.: 021- 33395800

 

Postal Code: 200233

 

Email: PR@lshhqj.com

 

Cookies Policy

When you visit our website, we may place small data files known as “cookies” on your device. Cookies enable our website to recognize your browser and help us understand how visitors use the site.

 

Cookies and similar technologies used on this website may collect online identifiers, device information, browser information, IP address, and information about how you interact with the website. In certain circumstances, such information may constitute personal information or may be associated with you under applicable PRC laws and regulations. Information collected through cookies is used for purposes such as ensuring website operation, maintaining security, analyzing traffic and performance, remembering user preferences, and improving website content and user experience.

 

You may choose to accept or decline cookies by adjusting your browser settings or through any cookie banner or preference center made available on our website, if applicable. Please note that disabling cookies may affect the functionality of certain parts of the website.

 

For more information about how we process personal information, please refer to our Privacy Notice.

 

Some cookies may be provided by third parties. Where third-party cookies or similar technologies are used, such third parties may process the relevant information in accordance with their own privacy policies and applicable PRC laws and regulations.

Accessibility

Shanghai Henlius Biotech, Inc. (“Henlius”) is committed to improving the accessibility and user friendliness of its website for all visitors.

 

We strive to ensure that the content on our website can be accessed and used by individuals with diverse needs, including those who rely on assistive technologies. As our website continues to evolve, we recognize that accessibility is an ongoing effort, and we are continuously working to improve usability and accessibility across our digital platforms.

 

If you experience difficulty accessing any part of our website, or have suggestions on how we can enhance accessibility, we welcome your feedback. To help us respond effectively, please include the specific webpage address (URL) and a brief description of the issue encountered.

 

Contact us:

Email: PR@lshhqj.com

(Please include “Website Accessibility” in the subject line)

Henlius will make reasonable efforts to review accessibility-related feedback and improve the overall online experience for all users. While we strive to improve accessibility, we do not guarantee that every page or feature will be fully accessible to every user in all circumstances.

Terms of Use

This website (http://www.lshhqj.com/) is developed and operated by Shanghai Henlius Biotech, Inc. (“Henlius”). Please read these Terms of Use carefully before accessing or using this website. By accessing, browsing or using this website, you acknowledge that you have read, understood and agreed to be bound by these Terms of Use and applicable PRC laws and regulations.

 

Henlius reserves the right to modify or update these Terms of Use at any time. Any updated version will be posted on this website with a revised “Last Updated” date. Please review them periodically for updates.

 

Prohibited Conduct:

 

You shall not infringe the lawful rights and interests of Henlius or any third party, nor interfere with or attempt to interfere with the normal operation, security, or integrity of this website by any means. Without limitation, you shall not use this website for any unlawful purpose, attempt unauthorized access to any part of the website or related systems, introduce malicious code, scrape or extract website content through automated means, or otherwise interfere with the website’s operation or security features.

 

Copyright

 

All content on this website, including but not limited to text, data, logos, graphics, audio, video and other materials, is owned by Henlius or its respective rights holders, unless otherwise stated. Such content is protected by applicable Chinese and international copyright laws. This website and its content may be accessed and used only for lawful, personal, and non-commercial purposes. Without prior written consent, no entity or individual may copy, reproduce, republish, upload, post, transmit, distribute, modify, create derivative works from, mirror, or otherwise use such content for commercial or public purposes.

 

Disclaimers

 

To the fullest extent permitted by applicable PRC laws and regulations, Henlius makes no warranties or representations, express or implied, regarding the content of this website, including but not limited to accuracy, completeness, timeliness or suitability for any particular purpose. Henlius does not undertake any obligation to update the content of this website , except as otherwise required by applicable PRC laws and regulations.

 

You use this website and any information obtained from it at your own risk. To the fullest extent permitted by applicable PRC laws and regulations, Henlius shall not be liable for any loss or damage arising from the use or inability to use this website, including but not limited to system failures, computer viruses or data loss.

 

Medical Information

 

Nothing on this website constitutes medical advice, diagnosisor treatment recommendations. Medical decisions should always be made in consultation with qualified healthcare professionals. Any product-related or disease-related information provided on this website is provided for general informational purposes only and should not be construed as medical advice, diagnosis, or treatment recommendations; any product information is subject to the approved prescribing information and applicable local laws and regulations.

 

Third Party Websites

 

This website may contain links to third party websites for convenience. Henlius is not responsible for the content, availability, privacy practices, terms or use of such third-party websites. Access to third party websites is at your own risk.

 

Privacy

 

Henlius respects your privacy. Please refer to our Privacy Notice for details.

 

Governing Law

 

These Terms of Use shall be governed by the laws of the People’s Republic of China.

 

Last updated: March 30, 2026