By Fineline Cube 
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276, HKG: 1276) announced that the National Medical Products Administration (NMPA) has accepted the marketing application for its oral SHR7280 tablet. The drug is designed to block premature luteinizing hormone (LH) surges in patients undergoing controlled ovarian stimulation (COS) as part of assisted reproductive technology (ART) protocols.
Product Overview
- SHR7280 is a small‑molecule GnRH receptor antagonist that competitively inhibits endogenous GnRH binding, thereby suppressing gonadotropin (LH and FSH) synthesis and release.
- The oral formulation offers a convenient alternative to the current injectable GnRH antagonists used in COS, potentially improving patient compliance and reducing clinic visits.
- No oral GnRH antagonists have yet received approval for assisted reproduction, either in China or abroad, placing SHR7280 as a first‑in‑class candidate.
Clinical Impact
| Feature | Benefit | Clinical Context |
|---|---|---|
| Oral delivery | Patient convenience | Reduces the need for daily injections during COS cycles |
| Rapid LH suppression | Prevents premature LH surges | Enhances follicular recruitment and oocyte yield |
| Small‑molecule | Potentially lower cost | Makes the therapy accessible to a broader ART patient base |
Regulatory Milestone
- The NMPA acceptance removes the final regulatory barrier before a commercial launch, allowing Jiangsu Hengrui to initiate post‑marketing studies and distribution plans.
- The decision aligns with China’s strategic push to expand domestic fertility‑medicine innovation and reduce reliance on imported ART technologies.
Market Implications
- The global ART drug market is projected to exceed $3 billion by 2035; an oral GnRH antagonist could capture a significant share of this growing segment.
- Competitors such as Merck (Goserelin) and AbbVie (Cetrorelix) currently rely on injectable agents; SHR7280 may shift the therapeutic landscape toward oral solutions.
- Jiangsu Hengrui’s move may accelerate the adoption of oral ART agents in Asia, potentially prompting similar approvals in other jurisdictions.-Fineline Info & Tech