Inventiva announced receipt of a $10 million milestone payment from Chia Tai-Tianqing Pharmaceutical Group Co., Ltd (CTTQ), a subsidiary of Sino Biopharm, marking progress in their collaboration to develop lanifibranor for metabolic dysfunction-associated steatohepatitis (MASH) treatment in Greater China. The milestone payment follows successful settlement of the second tranche of €115.6 million in gross proceeds from Inventiva's structured financing program.
Partnership Expands MASH Development in China
The milestone payment originates from a licensing and collaboration agreement established in September 2022 and amended in October 2024. Under this agreement, CTTQ holds rights to develop and commercialize lanifibranor for MASH and potentially other metabolic diseases across Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan.
The partnership structure positions Inventiva to receive up to an additional $265 million in clinical, regulatory, and commercial milestone payments, alongside royalties in the low single digits on annual net sales of lanifibranor if approved. This financial framework supports the continued development of the pan-PPAR agonist through regulatory approval and potential commercialization.
Breakthrough Therapy Designation Accelerates Development
Lanifibranor has secured Breakthrough Therapy Designation for MASH from both the U.S. Food and Drug Administration in October 2020 and the Chinese National Medical Products Administration (NMPA) in December 2023. This designation, based on results from the Phase 2b NATIVE clinical trial, could potentially accelerate development and regulatory review for this serious liver condition.
The dual regulatory recognition underscores the therapeutic potential of lanifibranor in addressing MASH, described as a common and progressive chronic liver disease. The breakthrough status in both jurisdictions provides a regulatory pathway that could expedite the drug's progression through clinical development and approval processes.
Phase 3 Trial Advances with Chinese Participation
CTTQ has joined Inventiva's ongoing NATiV3 pivotal Phase 3 clinical trial, which now includes over 60 sites across mainland China. This expansion significantly broadens the trial's geographic reach and patient recruitment potential for the pivotal study evaluating lanifibranor in adult patients with MASH.
Importantly, CTTQ has completed a Phase I bridging study that confirmed no significant ethnic differences in lanifibranor's profile. This finding paves the way for CTTQ to seek regulatory approval in China based on results from the global NATiV3 trial, potentially streamlining the approval process and reducing development timelines in the Chinese market.
Clinical-Stage Company Focuses on Oral MASH Therapies
Inventiva operates as a clinical-stage biopharmaceutical company with a focused approach on developing oral small molecule therapies for MASH treatment. The company's primary asset, lanifibranor, represents a novel pan-PPAR agonist currently being evaluated in the NATiV3 Phase 3 trial.
The company maintains dual listings on Euronext Paris and the Nasdaq Global Market, trading under the ticker IVA. This milestone payment represents a significant financial achievement for the clinical-stage company as it advances its lead program through pivotal development phases.
