On September 15, Chia Tai Tianqing, a core enterprise of Sino Biopharm (1177.HK), received a drug registration certificate from the National Medical Products Administration (NMPA) for Degarelix Acetate for Injection, for use in patients with prostate cancer who require androgen deprivation therapy (ADT). As the world's first successfully developed generic degarelix acetate, this product has received marketing approval in Europe and tentative approval in the United States. Through a successful patent challenge, it has also secured a 12-month market exclusivity period in China, providing a benchmark case for breaking patent barriers for similar complex formulations. 

Approved in China, the US, and Europe, Benefiting Prostate Cancer Patients

Following the marketing approval by the European Medicines Agency (EMA) in September 2023, Degarelix Acetate for Injection received tentative approval from the U.S. Food and Drug Administration (FDA) in August 2025, and has now been approved for marketing by the NMPA. The authoritative approvals from multiple regulatory agencies not only provide momentum for Sino Biopharm's expansion into the global neoplasm treatment market, but also signify that Sino Biopharm has reached an internationally leading level in core capabilities such as pharmaceutical R&D of complex formulations, quality control systems, and patent breakthroughs. 

Prostate cancer is the most common type of cancer in the male genitourinary system^[1] and the second most common cancer in men^[2]. The standard first-line therapy in clinical practice is ADT. As a gonadotropin-releasing hormone (GnRH) antagonist, degarelix acetate works by reversibly binding to GnRH receptors in the pituitary gland, reducing the release of gonadotropins and testosterone, thereby exerting its anti-prostate cancer effect. Since its first launch in the US in 2008, degarelix acetate has been recognized by multiple authoritative domestic and international guidelines^[3-6]. 

Successful Patent Challenge, Securing "Exclusivity Period" Once Again

Degarelix acetate is a highly complex injectable product, and previously only the originator drug was marketed domestically and internationally. Chia Tai Tianqing overcame the technical challenges of the active pharmaceutical ingredient and drug product one by one, and independently resolved several key difficulties such as a customized compounding system, in-vitro dissolution apparatus, and a multi-method orthogonal evaluation system. By leveraging a drug-device combination product R&D system and a GMP production management system that comply with European and US standards, it passed inspections with high quality, gaining full recognition from the three major regulatory agencies in China, the US and Europe, and achieving the world's first exclusive generic. 

Degarelix acetate is also the second drug to receive a 12-month market exclusivity period through the "first generic + successful patent challenge" since the implementation of the early resolution mechanism for drug patent disputes. The first product was Everolimus Tablets (Qingweishi^®), approved for marketing in December 2023. In 2023 and 2024, Chia Tai Tianqing filed invalidation requests for two core patents of degarelix acetate registered on China's Patent Information Registration Platform for Marketed Drugs, and the requests were supported by the Beijing Intellectual Property Court, resulting in a successful patent challenge. 

Through the "first generic + patent challenge", the launch of degarelix acetate independently developed by Chia Tai Tianqing will break the originator product's monopoly in the Chinese market, thereby promoting market competition and reducing the medication burden on patients. In the future, the company will continue to focus on breakthroughs in key technologies to provide more treatment options for patients. 

References:
[1]SIEGEL R L,MILLER K D,FUCHS H E,et al.Cancer statistics,2021[J].CA Cancer J Clin,2021,71(1):7-33.
[2]BRAY F,LAVERSANNE M,SUNG H,et al.Global cancer statistics 2022:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries[J].CA Cancer J Clin,2024,74(3):229-263.
[3] National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Prostate Cancer (2022). 
[4] Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Prostate Cancer (2021). 
[5] European Association of Urology (EAU) Guidelines on Prostate Cancer (2021). 
[6] Japanese Urological Association (JUA) Guidelines on Prostate Cancer (2016). 

Disclaimer:
1. This press release is intended to facilitate the communication and exchange of medical information and is for reference by healthcare professionals only. It is not for advertising purposes. 
2. The company does not recommend any drugs and/or indications. 
3. The information contained in this press release is for reference only and cannot replace professional medical guidance in any way, nor should it be considered as a diagnosis or treatment recommendation. If you wish to understand specific information about disease diagnosis and treatment, please follow the advice or guidance of a doctor or other healthcare professional. 

Forward-Looking Statements:
This press release contains certain forward-looking statements, including statements regarding the clinical development plans, expectations of clinical benefits and advantages, commercialization outlook, the likelihood of clinical benefit for [Degarelix Acetate for Injection (Qinglishu®), Everolimus Tablets (Qingweishi®)]. Words such as "expect", "believe", "continue", "may", "estimate", "hope", "intend", "plan", "potential", "predict", "project", "should", "will", "propose", and similar expressions are intended to identify forward-looking statements, but not all forward-looking statements contain these identifying words. These forward-looking statements are predictions or expectations made by the company based on currently available data and information, and actual results may differ materially from these forward-looking statements due to uncertainties or risks such as policy, R&D, market, and regulatory factors. Current or potential investors are advised to carefully consider the potential risks and should not place undue reliance on the forward-looking statements in this press release, which contain information only as of the date of this press release. Unless required by law, the company undertakes no obligation to update or revise any forward-looking statements in this press release as a result of new information, future events, or other circumstances.