By Fineline Cube 
Sino Biopharmaceutical Limited (HKG: 1177) announced that its subsidiary Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ) has received approval from the China National Medical Products Administration (NMPA) for the first‑in‑world generic of Degarelix Injection, a highly complex androgen‑deprivation therapy used in prostate cancer.
Product & Regulatory Milestones
| Milestone | Detail |
|---|---|
| Original Development | Degarelix (brand name Firmagon) – first approved in the U.S. in 2008, entered the Chinese market in 2018. |
| CTTQ Generic | First generic version worldwide: approved in the EU (Sept 2023), provisional U.S. approval (Aug 2025). |
| NMPA Approval | Granted in September 2025 for use in prostate cancer patients requiring androgen‑deprivation therapy. |
| Patent Challenge | CTTQ successfully defended its generic claim, earning a 12‑month exclusivity period in China. |
Market & Commercial Impact
- Pricing Advantage – The generic offers a lower‑cost alternative to the branded product, potentially capturing a significant share of the ~30,000 Chinese prostate‑cancer patients on androgen‑deprivation therapy each year.
- Supply Chain – CTTQ’s established manufacturing footprint in Jiangsu positions it to meet the demand of both domestic and regional markets.
- Strategic Positioning – Sino Biopharmaceutical’s expansion into oncology generics strengthens its portfolio and aligns with China’s broader push for affordable, high‑quality biopharmaceuticals.
Company Outlook
Sino Biopharmaceutical’s successful navigation of the complex regulatory and patent landscape underscores its growing reputation as a leading biopharma platform in China. The degarelix generic is expected to accelerate revenue growth and enhance the company’s standing among global oncology players.-Fineline Info & Tech