SHANGHAI and JERSEY CITY, N.J., Sept. 19, 2025 /PRNewswire/ — Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for BILDYOS^® (denosumab) injection 60 mg/mL and BILPREVDA^® (denosumab) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.^[1],[2]

“The EC approvals of BILDYOS and BILPREVDA mark a pivotal moment in expanding access to essential bone care treatments for millions of Europeans, particularly women, who are disproportionately affected by osteoporosis,” said Nico Van Hoecke, Head, International Commercial at Organon.^[3],[4] “These biosimilars may offer additional treatment options across several therapeutic areas associated with bone loss, including osteoporosis, and reflect Organon’s commitment to advancing women’s health through access to important medicines.^[4] These approvals, following those in the United States, not only expand the global reach of these biosimilars but also support the sustainability of Europe’s health care systems.”^[5],[6]

“These approvals are a testament to the strong collaboration between Henlius and Organon aimed at meeting the needs of both patients and the health care system in Europe,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. “Through our commitment to scientific excellence and product quality, we’re building on approvals in the United States to bring these biosimilar treatment options to people who need them around the world.”^[6]

BILDYOS is indicated for treatment of osteoporosis in postmenopausal women and in men at increased risk for fracture, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. BILPREVDA is indicated for the prevention of skeletal related events in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

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 each a biological medicine highly similar to another biological medicine already approved in the EU (called ‘reference medicine’) in terms of structure, biological activity and efficacy, safety and immunogenicity profile (the intrinsic ability of proteins and other biological medicines to cause an immune response).^[4]

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.^[7]

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. To date, 9 products have been approved for marketing across multiple countries and regions, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company’s launched products include HANSIZHUANG (serplulimab, trade name: Hetronifly in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANLIKANG (rituximab), the first China-developed biosimilar, and denosumab BILDYOS and BILPREVDA. What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.

To learn more about Henlius, visit https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

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, Instagram, X, YouTube, TikTok 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 allocations, 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 Europe by Amgen, Inc.; Organon is not associated with this trademark owner.

SAN FRANCISCO and SUZHOU, China, Sept. 19, 2025 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that China’s National Medical Products Administration (NMPA) has approved mazdutide, a first-in-class dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist, for glycemic control in adults with type 2 diabetes (T2D). Mazdutide is the world’s first dual GCG/GLP-1 receptor agonist approved for glycemic control in adults with T2D. It is expected to support disease management for the vast T2D population in China, achieving comprehensive benefits in glycemic control, weight reduction and hepato-cardio-renal metabolic indicators.

China has the highest number of T2D affected patients, facing urgent challenges in long-term glucose management and complication prevention

China leads the world in diabetes prevalence, with 140 million adults affected (1 in 4 global cases). Diabetes is a chronic condition where prolonged hyperglycemia can lead to severe complications, such as cardiovascular diseases, nephropathy, retinopathy and neuropathy. These complications not only endanger patients’ lives and health but also impose a significant economic burden on families and society.

In recent years, the treatment paradigm for diabetes has progressively shifted from glycemic control alone to a comprehensive, patient-centric management strategy. This approach integrates glycemic control, weight management, cardiovascular risk factor mitigation, and prevention/treatment of hepato-cardio-renal complications.

The ADA/EASD Consensus Report on the Management of Hyperglycemia in T2D has formally recognized weight reduction as a core therapeutic target. Weight loss should be prioritized not only to improve glycemic outcomes but also to reduce the risk of weight-related complications. For some patients with T2D, achieving a 5%–15% reduction in body weight is recommended as a primary treatment goal.

Mazdutide: superior glycemic control and weight loss, with hepato-cardio-renal metabolic benefits, supporting Healthy China 2030

Building upon the established effects of GLP-1 receptor agonists, dual GCG/GLP-1 receptor agonists simultaneously improve the two core pathogenic mechanisms of diabetes – insufficient insulin secretion and insulin resistance, thus, delivering comprehensive benefits beyond glycemic control, including weight loss, and hepato-cardio-renal metabolic improvements. As a safe, effective and convenient novel therapeutic option, mazdutide addresses the critical needs of long-term glucose management and complication prevention in T2D, actively supporting the realization of the “Healthy China 2030” vision.

The approval was based on two Phase 3 clinical trials (DREAMS-1 [NCT05628311] and DREAMS-2 [NCT05606913]), which evaluated the efficacy and safety of mazdutide as monotherapy and in combination with oral antidiabetic drugs, respectively, in Chinese participants with T2D. These studies demonstrated mazdutide’s superiority over placebo or dulaglutide 1.5 mg in glycemic control and weight reduction, while also showing improvements in multiple cardiometabolic, hepatic and renal parameters.

• DREAMS-1: for the efficacy estimand, at Week 24, the mean changes in HbA1c from baseline in the mazdutide 4 mg group, mazdutide 6 mg group and placebo group were -1.57%, -2.15%, and -0.14%, respectively; the proportion of participants with HbA1c <7% were 68.6%, 87.4% and 10.7%, respectively; the mean percent change in body weight from baseline were -5.61%, -7.81% and -1.26%, respectively; and the proportion of participants with HbA1c <7% and a body weight reduction≥5% were 40.6%, 64.9%, and 0%, respectively.
• DREAMS-2: for the efficacy estimand, at Week 28, the mean changes in HbA1c from baseline in the mazdutide 4 mg group, mazdutide 6 mg group and dulaglutide 1.5 mg group were -1.69%, -1.73% and -1.38%, respectively; the proportion of participants with HbA1c <7% were 71.2%, 74.2% and 62.1%, respectively; the mean percent change in body weight from baseline were -7.31%, -9.24% and -2.86%, respectively; and the proportion of participants with HbA1c <7% and a body weight reduction≥5% were 50.1%, 64.3%, and 19.4%, respectively.

Mazdutide exhibited a safety profile consistent with previous clinical studies and other GLP-1R agonists, with no new safety signals identified.

DREAMS-1 results were orally presented (Abstract #: 306-OR) at the 85th Scientific Sessions of the ADA; DREAMS-2 results were presented as a late-breaking oral presentation (Abstract #: LBA 16) at the 60th Annual Meeting of the EASD. Based on the innovative mechanism and robust evidence of mazdutide, it has been recommended in expert consensus in China..

It is worth noting that the mazdutide injection device demonstrates significant improvements in both convenience and safety compared to existing injection devices of the same type. The device features a hidden needle, ensuring the needle remains out of sight throughout the process, effectively reducing patient anxiety associated with injections. Additionally, it is a single-use device, designed for immediate disposal after use, which significantly lowers the risk of drug contamination caused by reuse or improper handling. Furthermore, the injection device incorporates innovative X-cross-section technology, delivering a smoother and painless injection experience, thereby enhancing patient comfort and treatment adherence.

Professor Dalong Zhu, the Principal Investigator of DREAMS-1 study, Nanjing University Affiliated Drum Tower Hospital, said: “China has a high prevalence of T2D globally, with over 140 million adult patients. A significant proportion of these individuals also suffer from overweight or obesity, cardiovascular diseases, and/or kidney diseases, making prevention and treatment particularly challenging. Mazdutide, as a dual GCG/GLP-1 receptor agonist, demonstrated superior efficacy in glycemic control and weight reduction compared to placebo in the DREAMS-1 study in Chinese patients with T2D inadequately managed by diet and exercise alone. It also showed a favorable safety profile. Additionally, mazdutide offered improvements such as reduced waist circumference, blood pressure and lipid levels. I am pleased to see mazdutide’s pivotal clinical study results in T2D patients have gained approval from national regulatory authorities, culminating in its market authorization, which could offer a new treatment option for T2D patients in China.”

Professor Jiajun Zhao, the Principal Investigator of DREAMS-1 study, Shandong Provincial Hospital, said: “In recent years, the treatment for diabetes has gradually shifted from mere glycemic control to a ‘patient-centered’ approach, integrating glycemic control, weight management, cardiovascular risk factor management, and addressing cardiorenal comorbidities and complications. GLP-1 receptor agonists not only excel in glycemic control but also effectively reduce weight, making them a hotspot and frontier in metabolic disease drug development. The Phase 3 study of mazdutide in participants with T2D has once again confirmed its outstanding efficacy in glycemic control and weight reduction, along with multiple metabolic benefits and a favorable safety profile. I am delighted to see the approval of mazdutide for the indication of glycemic control in adults with T2D, and I hope it will bring significant benefits to patients with T2D in China.”

Professor Lixin Guo, the principal investigator of the DREAMS-2 study, Beijing Hospital, said: “China has a high prevalence of T2D, yet the overall glycemic control rate among patients remains suboptimal. Many patients also accompany multiple cardiovascular risk factors such as obesity, hyperlipidemia, coronary heart disease, fatty liver disease, and renal diseases, which not only increase disease burden but also complicate treatment. There is an urgent clinical need for innovative therapies that demonstrate proven efficacy, favorable safety, convenient administration, and multiple cardiovascular benefits. The Phase 3 clinical study results of mazdutide in Chinese participants with T2D demonstrated not only significant glucose-lowering efficacy but also showed potential superiority over the dulaglutide in weight reduction. The approval of mazdutide for glycemic control in adults with T2D will provide more treatment options to Chinese T2D patients.”

Professor Wenying Yang, the principal investigator of the DREAMS-2 study, China–Japan Friendship Hospital, said: “In recent years, GLP-1 receptor agonists have emerged as superior therapeutic options for T2D patients by delivering comprehensive benefits in glycemic control, weight management, and cardiovascular/renal outcomes. As the first approved dual GCG/GLP-1 receptor agonist, Mazdutide demonstrated better efficacy than dulaglutide in both glucose-lowering and weight reduction during Phase 3 study in participants with T2D, while also showing multiple metabolic advantages and favorable safety profiles. These robust clinical results support its application as a next-generation GLP-1-based therapy for Chinese patients with T2D. I am delighted that Mazdutide has entered clinical practice, offering a novel treatment alternative for eligible T2D patients and contributing to improved clinical outcomes in diabetes management.”

Dr. Lei Qian, Chief R&D Officer of General Biomedicine from Innovent Biologics, stated, “Mazdutide represents the next-generation dual GCG/GLP-1 receptor agonist. Multiple clinical studies of mazdutide conducted in Chinese adults with T2D have demonstrated mazdutide’s exceptional dual advantages in both glycemic control and weight reduction across two major patient populations—those receiving monotherapy and those failing on multiple oral antidiabetic drugs. The treatment has shown multiple metabolic benefits for cardiovascular, hepatic and renal systems while maintaining an excellent safety profile. The successful approval of mazdutide reflects the national drug regulatory authority’s strong endorsement of its clinical value and safety profile, while fully validating Innovent Biologics’ innovative R&D capabilities in metabolic therapeutics. We hope mazdutide will provide superior treatment options for Chinese patients with T2D and help alleviate the disease burden on our society.”

About Diabetes

According to the 2021 global diabetes overview by the International Diabetes Federation, China leads the world in the number of patients with diabetes, with an estimated 140 million cases in 2021 and projected to reach 174 million by 2045^[1]. Poor glycemic control can lead to irreversible microvascular and macrovascular complications, including reduced visual acuity, blindness, renal dysfunction, peripheral neuropathy, myocardial infarction, stroke and amputation^[2]. The high prevalence of diabetes and its serious complications pose a significant threat to human health. Currently, various therapeutic approaches are available for diabetes management. In addition to controlling blood glucose, new hypoglycemic drugs are being developed to offer additional benefits such as weight loss, cardiovascular risk reduction and kidney protection^[3].

About Mazdutide

Innovent entered into an exclusive license agreement with Eli Lilly and Company (Lilly) for the development and potential commercialization of mazdutide, a dual GCG /GLP-1 receptor agonist, in China. As a mammalian oxyntomodulin (OXM) analogue, in addition to the effects of GLP-1 receptor agonists on promoting insulin secretion, lowering blood glucose and reducing body weight, mazdutide may also increase energy expenditure and improve hepatic fat metabolism through the activation of glucagon receptor. Mazdutide has demonstrated excellent weight loss and glucose-lowering effects in clinical studies, as well as reducing waist circumference, blood lipids, blood pressure, serum uric acid, liver enzymes, liver fat content and improved insulin sensitivity.

Mazdutide has conducted seven Phase 3 clinical studies, including:

• GLORY-1: A Phase 3 clinical study conducted in Chinese adults with overweight of obesity;
• GLORY-2: A Phase 3 clinical study conducted in Chinese adults with moderately to severely obesity;
• GLORY-3: A Phase 3 clinical study comparing mazdutide versus semaglutide in Chinese adults with overweight of obesity accompanied metabolic-associated fatty liver disease (MAFLD);
• GLORY-OSA: A Phase 3 trial in Chinese participants with obstructive sleep apnea (OSA) and obesity;
• DREAMS-1: A Phase 3 clinical study conducted in Chinese adults with untreated type 2 diabetes;
• DREAMS-2: A Phase 3 clinical study comparing mazdutide versus dulaglutide in Chinese adults with type 2 diabetes who have poor glycemia control with oral medication;
• DREAMS-3: A Phase 3 clinical study comparing mazdutide versus semaglutide in Chinese adults with type 2 diabetes and obesity;

Among these, GLORY-1, DREAMS-1, and DREAMS-2 have already met their primary endpoints and the other four studies are currently ongoing.

In addition, several new clinical studies of mazdutide are initiated or planned, including:

• A Phase 3 trial in adolescents with obesity;
• New studies in patients with metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction (HFpEF).

*Mazdutide has received NMPA approval for two indications:

First Indication: as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial Body Mass Index (BMI) of:

• BMI ≥ 28 kg/m² (obesity); or
• BMI ≥ 24 kg/m² (overweight) in the presence of at least one weight-related comorbid condition (e.g., hyperglycemia, hypertension, dyslipidemia, fatty liver, or obstructive sleep apnea syndrome and etc.);

Second Indication (Newly Approved): glycemic control in adults with type 2 diabetes:

Monotherapy

For adults with type 2 diabetes who have inadequate glycemic control despite diet and exercise interventions.

Combination Therapy

For adults with T2D who still have poor glycemic control despite:

Diet and exercise, plus Metformin and/or sulfonylureas, or Metformin and/or SGLT2 inhibitors (SGLT2i).

About Innovent Biologics

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 16 products in the market. It has 2 new drug applications under regulatory review, 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, LG Chem and MD Anderson Cancer Center.

Guided by the motto, “Start with Integrity, Succeed through Action” Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Statement:  Innovent does not recommend the use of any unapproved drug (s)/indication (s).

Forward-looking statement

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, “intend” and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent’s competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.