World's first generic Degarelix approved for marketing
Sino Biopharm
Pharmaceutical R&D Developer
CHIATAI TIANQING
High-quality pharmaceuticals research, production, and sales provider
On September 15, CTTQ Pharma—a core subsidiary of Sino Biopharmaceutical Limited (1177.HK)—obtained marketing approval from China's National Medical Products Administration (NMPA) for its generic Degarelix Acetate for Injection, indicated for prostate cancer patients requiring androgen deprivation therapy. As the world's first successfully developed generic version of degarelix acetate, the product has already received marketing authorization in Europe and tentative approval in the United States. Through a successful patent challenge, the company has secured 12-month market exclusivity in China, establishing a benchmark for overcoming patent barriers in developing complex generic formulations.
Approved in China, U.S., and EU: Benefiting Prostate Cancer Patients
Following its approval by the European Medicines Agency (EMA) in September 2023, Degarelix Acetate for Injection has now received tentative approval from the U.S. Food and Drug Administration (FDA) in August this year, as well as recent market authorization from China's NMPA. These endorsements from leading international regulatory authorities not only bolster the company's expansion into the global oncology therapeutics market but also demonstrate its world-class capabilities in R&D of complex formulations, quality control, and patent challenges.
Prostate cancer is the most common genitourinary cancer in men[1] and the second most frequently diagnosed cancer among males worldwide[2]. Androgen deprivation therapy (ADT) is a commonly used first-line clinical treatment. As a gonadotropin-releasing hormone (GnRH) antagonist, degarelix acetate reversibly binds to GnRH receptors in the pituitary gland, reducing the release of gonadotropins and testosterone, thereby inhibiting the progression of prostate cancer. Since its initial approval in the U.S. in 2008, degarelix acetate has been recommended in multiple authoritative international and domestic treatment guidelines[3-6].
Another Market Exclusivity Achieved Through Successful Patent Challenge
Degarelix acetate is a highly complex injectable product, with only the originator drug previously available in global markets. CTTQ Pharma independently overcame multiple technical challenges related to both the active ingredient and the formulation, developing customized preparation systems, in vitro dissolution devices, and a multi-method orthogonal evaluation system. The company's combination product development and GMP production management systems, which meet both U.S. and European standards, passed rigorous inspections, earning comprehensive approval from the FDA, EMA, and NMPA as the world's first and only generic version.
This marks the company's second product to obtain 12-month market exclusivity in China under the country's early patent dispute resolution mechanism, following the approval of Everolimus Tablets (branded as Qing Wei Shi®) in December 2023. In both 2023 and 2024, CTTQ Pharma successfully filed invalidation claims against two core patents listed for degarelix acetate in China's marketed drug patent information registry—a move supported by the Beijing Intellectual Property Court.
By leveraging first generic development and successful patent challenges, the launch of CTTQ Pharma's independently developed degarelix acetate will break the originator's market monopoly in China, stimulate competition, and reduce the treatment burden for patients. Moving forward, the company remains committed to achieving breakthroughs in key technologies and providing more therapeutic options for patients worldwide.
References:
[1] SIEGEL R L, MILLER K D, FUCHS H E, et al. Cancer statistics, 2021[J]. CA: A Cancer Journal for Clinicians, 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: A Cancer Journal for Clinicians, 2024, 74(3): 229–263.
[3] National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer (2022 Version).
[4] Chinese Society of Clinical Oncology (CSCO). Guidelines for Diagnosis and Treatment of Prostate Cancer (2021).
[5] European Association of Urology (EAU). EAU Guidelines on Prostate Cancer (2021).
[6] Japanese Urological Association (JUA). Guidelines for Prostate Cancer (2016).
Source: Sino Biopharmaceutical Limited