CHINA– Chinese Peptide Company, a subsidiary of Medtide Inc., has achieved a significant regulatory milestone by securing market approval for its independently developed goserelin acetate Active Pharmaceutical Ingredient (API) from China's National Medical Products Administration (NMPA).

Regulatory Achievement

The approval was granted following a comprehensive separate review conducted by the Center for Drug Evaluation (CDE), the NMPA's technical review body. According to official records on the CDE's Excipients and Packaging Materials Registration Platform, the API's registration status has been updated to "A," confirming full compliance with China's Good Manufacturing Practice (GMP) standards for pharmaceuticals and establishing legal authorization for formulation production.

Goserelin: A Core Drug for Hormone-Dependent Diseases

Mechanism and Clinical Applications

Goserelin acetate is a Gonadotropin-Releasing Hormone Agonist (GnRH-a) that regulates hormone production through a sophisticated dual-phase mechanism. Upon administration, it initially stimulates the pituitary gland, causing a temporary surge in gonadotropin secretion. This is followed by receptor desensitization, which ultimately suppresses ovarian and testicular functions, leading to significant reductions in estrogen and testosterone levels.

The drug has established itself as a cornerstone therapy across multiple therapeutic areas:

Oncology Applications:

• Adjuvant treatment for hormone-dependent malignancies, including prostate and breast cancers
• Essential component of hormone suppression protocols in cancer management

Gynecological Disorders:

• First-line treatment for endometriosis management
• Therapeutic intervention for uterine fibroids and related hormonal conditions

Market Development and Regulatory Milestones

Originally developed by AstraZeneca, goserelin acetate made its U.S. debut in 1989 under the brand name Zoladex®. The drug's entry into the Chinese market followed a structured timeline:

• 1996: 3.6 mg formulation received regulatory approval in China
• 2012: 10.8 mg long-acting formulation entered the Chinese market
• 2023: Domestic innovation accelerated with Luye Pharma's launch of "Baituo Wei," the first domestically produced goserelin acetate sustained-release microsphere (classified as a Class 2.2 improved new drug)

Recent Market Developments

Luye Pharma's domestic breakthrough has gained significant traction:

• June 2023: Initial approval for prostate cancer indication
• September 2023: Indication expansion to include breast cancer
• January 2024: Inclusion in China's National Medical Insurance Catalog for prostate cancer, significantly enhancing patient accessibility and market adoption

Strategic Breakthrough: API Localization and Market Impact

China has historically depended on imported goserelin acetate Active Pharmaceutical Ingredient (API), creating supply chain vulnerabilities and cost pressures. The recent approval of Chinese Peptide Company's domestically produced API represents a pivotal industry development.

Key Strategic Advantages

Technological Excellence:

• Implementation of international-standard cGMP manufacturing processes
• Achievement of purity and impurity control standards comparable to global benchmarks
• Breaking the long-standing monopoly of imported API suppliers

Supply Chain Optimization:

• Providing domestic formulation manufacturers with compliant, cost-effective API alternatives
• Enabling comprehensive industry-chain localization and reducing import dependencies
• Strengthening China's pharmaceutical manufacturing sovereignty

Competitive Differentiation:

• Shortened production cycles compared to imported alternatives
• Reduced manufacturing costs through local supply chain integration
• Accelerated research and development timelines for innovative formulations
• Enhanced supply chain resilience and regulatory compliance

Market Positioning and Future Outlook

Chinese Peptide Company has strategically positioned itself as a key enabler of domestic substitution, establishing collaborative relationships with multiple leading formulation enterprises. This network approach provides:

• Reliable raw material supply for expanded product portfolios
• Technical support for formulation development and optimization
• Accelerated pathway to market for domestic pharmaceutical companies

The company's API approval consolidates the domestic substitution process, reducing China's reliance on foreign suppliers while maintaining international quality standards. This development is expected to catalyze further innovation in hormone-dependent disease treatments and strengthen China's position in the global pharmaceutical supply chain.

As the market continues to evolve, the combination of domestic API production capability and innovative formulation development is positioning China to become increasingly self-sufficient in this critical therapeutic area, while potentially creating opportunities for international expansion of Chinese-manufactured goserelin products.

Industry Outlook

The goserelin acetate API and formulation market has huge potential, with the domestic market size expected to reach 6 billion yuan by 2025. Domestic substitution will extend from the API end to the formulation end, driving innovative R&D of peptide drugs and reducing medication costs for patients.As a peptide CRDMO service provider, Chinese Peptide Company's full-cycle service capabilities will further empower industry upgrading.