By Fineline Cube 
Shanghai Bao Pharmaceuticals Co., Ltd. has received official marketing authorization from China’s National Medical Products Administration (NMPA) for its recombinant human follicle‑stimulating hormone‑CTP fusion protein. The product, the country’s first long‑acting recombinant FSH‑CTP, will be distributed exclusively by Anhui Anke Biotechnology (Group) Co., Ltd. (SHE: 300009) under a July 2025 agreement that covers mainland China, Hong Kong, Macau, and Taiwan.
Product Overview
- Name: Recombinant human FSH‑CTP fusion protein
- Structure: Amino‑acid sequence identical to EU‑approved Corifollitropin α (CFA)
- Administration: Single‑dose injection
- Indication: Controlled ovarian stimulation (COS) in combination with GnRH antagonists
- Benefits: Comparable oocyte yield, embryo quality, and pregnancy outcomes to short‑acting FSH; enhanced safety profile; reduced dosing frequency
Regulatory Milestone
- Approval Date: 30 June 2025 (NMPA)
- Significance: First long‑acting recombinant FSH‑CTP approved in China, opening a new class of fertility therapeutics in the domestic market
Clinical Efficacy & Patient Impact
- Comparable Outcomes: Clinical trials demonstrate parity with conventional short‑acting FSH for key metrics (retrieved oocytes, embryo quality, live‑birth rates).
- Safety Advantage: Lower incidence of ovarian hyperstimulation syndrome (OHSS) reported in the pivotal study.
- Convenience: Single‑dose regimen cuts the number of clinic visits by ~70 %, improving patient adherence and reducing overall treatment burden.
Distribution Agreement & Market Outlook
- Exclusive Rights: Anke Biotech holds sole distribution rights across all Chinese territories, positioning it as the primary market entrant for long‑acting FSH therapy.
- Commercial Strategy: Target high‑volume fertility centers and IVF clinics; leverage existing sales network to accelerate uptake.
- Growth Projection: Analyst estimates a 30‑40 % market share of the domestic long‑acting FSH segment within 3 years, translating to an incremental revenue run‑rate of USD 20‑30 million by 2028.
Company Statements
“The NMPA approval validates our commitment to delivering innovative, patient‑centric fertility solutions,” said Ms. Li, Chief Commercial Officer at Anke Biotech. “Our exclusive partnership with Shanghai Bao enables us to bring this breakthrough therapy to Chinese patients faster and more safely.”
Bottom Line
The NMPA green light for Shanghai Bao’s FSH‑CTP, coupled with Anke Biotech’s exclusive distribution rights, marks a pivotal moment for China’s reproductive medicine market. The single‑dose, long‑acting formulation promises to streamline ovarian stimulation protocols, enhance safety, and deliver significant value to patients and clinicians alike.-Fineline Info & Tech