Innovent Asked to Supplement Additional Clinical Trials to Demonstrate the Applicability of Sintilimab in the U.S. Population and U.S. Medical Practice

February 11 at 10:30 a.m.,Innovent BioIt fell 3.66% to HK$32.9 per share, with a trading volume of over 9.12 million shares.Company pre-marketannouncementThe U.S. Food and Drug Administration (FDA) convened the Oncology Drug Advisory Committee (ODAC) to discuss and vote on the review of the company’s new drug marketing application (BLA) for sintilimab injection. Supplementary additional clinical trials to demonstrate the applicability of sintilimab in the U.S. population and U.S. medical practice.

The announcement shows that sintilimab is an innovative PD-1 inhibitor produced byInnovent BioandEli LillyCo-development and commercialization. The BLA application indication is sintilimab injection combined with pemetrexed and platinum for the first-line treatment of non-squamous non-small cell lung cancer (nsqNSCLC), mainly based on the ORIENT-11 Phase III clinical trial in China material.

According to public information,Innovent BioThe PD-1 inhibitor sintilimab ushered in the FDA ODAC review meeting on the evening of February 10. This is the first time that a domestic PD-1 tumor drug has faced ODAC directly and has passed the FDA. On February 10, Innovent Biodisk It once rose by more than 10%, and closed at HK$34.15 per share on the same day, up 6.06%.

Innovent said that ORIENT-11 is a high-quality, high-standard, Chinese clinical trial involving experienced clinical investigators that meets the requirements of the globally certified GCP. The ORIENT-11 trial results data demonstrate a favorable risk-benefit relationship for sintilimab. The FDA has not questioned the safety and efficacy of sintilimab. The FDA will adopt the ODAC votes during the new drug approval process, but the ODAC votes are not binding on the FDA’s decision-making.

Innovent Bio also stated that the company is confident in the clinical and commercial value of sintilimab. The in-depth communication and exchanges between the application and the US regulatory agencies have trained its overseas registration team and provided valuable experience for the global development of innovative pipelines. The company will be more determined to accelerate the global development of the pipeline and the global layout of innovative talents, accelerate the transformation from a biotech company (biotech) to a global biopharmaceutical company (global biopharma), and drive the company’s sustainable development.

(Article source: ChinasecuritiesReport · China Securities Network)

Article source: China Securities Journal China Securities Network

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Original title: Innovent was asked to supplement additional clinical trials to demonstrate the applicability of sintilimab in the U.S. population and U.S. medical practice