Overview of Domestic Complement Inhibitor R&D and Market Launch Status

The company announced today that its R&D team has fully covered all key intermediates in the complete synthetic chain of Novartis' oral complement factor B (Factor B) inhibitor Iptacopan (brand name Fabhalta®), including piperidine fragments with dual chiral centers, indole methyl fragments, and condensation precursors. The company has completed full-process validation across kilogram-scale → pilot-scale → industrial-scale manufacturing processes, and possesses the capability to supply high-purity, stable-batch, auditable DMF-level intermediates to API manufacturers, generic drug initiation parties, and new drug research institutions.

About the Market Background of Iptacopan

Iptacopan is Novartis' globally approved first oral complement alternative pathway Factor B inhibitor. It received FDA approval in December 2023 for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), was expanded to primary IgA nephropathy via accelerated approval in 2024, obtained routine multi-regional approval for PNH/C3G in 2025, and received NMPA approval for marketing in China (IgA nephropathy indication) in September 2025.

According to Novartis' 2025 financial report, the global sales of Fabhalta® amounted to approximately USD 505 million, representing a year-on-year increase of 287%; Q1 2026 single-quarter revenue reached USD 169 million, maintaining doubled growth. It is one of the fastest-growing molecules in the complement drug sector today.

With the gradual expiration of original compound patents and the expanding patient pool for IgA nephropathy/PNH/C3G in China, supply chain preparation for Iptacopan intermediates and API has become a key focus for generic drug companies and CDMOs.

Our Company's Technical Progress

• Coverage of two core fragments in the retrosynthetic analysis of Iptacopan (chiral piperidine benzyl ester fragment, 5-methoxy-7-methylindole fragment) and condensation carboxylic acid precursors;

•Dual chiral centers employ a combined process of asymmetric addition/ketoreductase-catalyzed reduction/crystallization resolution; key intermediates achieve ee ≥ 99.5%, de ≥ 99%, avoiding costly chiral column purification;

• A complete batch record system, impurity profile tracking, and starting material traceability system have been established, capable of providing intermediate DMF supporting documents upon client API submission.

Industrialization and Commercial Openness

Our Iptacopan intermediates currently possess stable delivery capability at the hundred-kilogram scale and reserved ton-level production capacity, supporting:

• Early procurement and process transfer for generic drug companies initiating Iptacopan hydrochloride API projects;

• Fragment customization for new drug companies developing same-target or structurally similar compounds (CFB inhibitors);

• Dedicated capacity lock-in under long-term framework agreements and joint process optimization.