INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics has received approval from the National Medical Products Administration (NMPA) for Pemazyre (pemigatinib) to treat adults with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion. This approval marks a significant step, as it is the first selective tyrosine kinase inhibitor authorized for this cancer type in China. The approval stems from clinical studies, including the FIGHT-202 study, which reported a 37% overall response rate (ORR) in patients. Pemazyre is also licensed to Innovent in several Greater China markets, enhancing its product coverage.

Innovent Biologics has announced the presentation of phase 3 clinical trial results for IBI306, a PCSK-9 inhibitor, at the ACC 2022. The study, involving Chinese patients with heterozygous familial hypercholesterolemia, demonstrated significant LDL-C reductions of -57.4% and -61.9% for 150 mg Q2W and 450 mg Q4W doses, respectively, with both showing favorable safety profiles. Innovent plans to submit a new drug application for IBI306 within the year, aiming to enhance treatment options for hypercholesterolemia in China.

Innovent Biologics reported its 2021 annual results, achieving a total revenue of RMB 4,261 million, with product revenue rising by 69% to RMB 4,001 million. The company now has a pipeline of 32 assets at various clinical stages, with a goal of expanding its commercial portfolio to over ten products in the next two years. Key developments include strategic collaborations with Eli Lilly, new product approvals, and a gross profit margin of 88.6%. However, a loss of RMB 2,243 million was reported for the year.

Innovent Biologics announced the first patient dosing of IBI389, a bispecific antibody targeting Claudin18.2 and CD3, in a Phase I clinical trial for advanced malignancies. This multicenter trial will assess the safety, tolerability, and efficacy of IBI389 alone or in combination therapy against advanced solid tumors. Preclinical results showed IBI389's promise in treating CLDN18.2-expressing cancers, particularly in patients with low expression levels. The company aims to leverage this innovative approach to enhance immune response and improve treatment outcomes for gastric and pancreatic cancers.

Innovent Biologics and Eli Lilly expand their strategic partnership to enhance cancer treatment options in China. Innovent will acquire sole commercialization rights for Cyramza® and Retsevmo® upon approval, and a right of first negotiation for Pirtobrutinib. Cyramza® is crucial for gastric and liver cancer, filling a significant treatment gap in China. The deal involves a total payment of US$45 million upon regulatory approvals. This agreement aims to increase Innovent's oncology portfolio to seven products, benefiting cancer patients.

Innovent Biologics and AnHeart Therapeutics announced that the Center for Drug Evaluation (CDE) of China's NMPA granted Breakthrough Therapy Designation to taletrectinib for ROS1-positive non-small cell lung cancer (NSCLC). This designation is based on Phase 2 trial results where taletrectinib showed a 90.5% objective response rate in treatment-naïve patients. The drug targets ROS1 fusion mutations, which affect 1-2% of NSCLC cases, and demonstrated good safety and efficacy profiles. Ongoing trials aim to further evaluate its potential for NSCLC patients.

Innovent Biologics announced that the first patient has been dosed in a phase 1 clinical trial for IBI325, a proprietary CD73 antibody targeting advanced solid tumors. This open-label study aims to assess safety, tolerability, and preliminary efficacy while establishing the recommended dose for future studies. IBI325 is designed to counteract immunosuppression in the tumor microenvironment, potentially enhancing the effectiveness of existing cancer therapies. Preclinical studies suggest robust anti-tumor activity, raising hopes for addressing unmet medical needs in cancer treatment.

Innovent Biologics has announced the first patient dosing of its universal "modular" CAR-T cell therapy, IBI345, for advanced Claudin18.2-positive solid tumors as part of an investigator-initiated trial. This milestone follows Innovent's collaboration with Roche, initiated in June 2020. The trial aims to evaluate the safety and preliminary efficacy of IBI345, which utilizes a unique mechanism of action to enhance treatment for aggressive tumors such as gastric and pancreatic cancers. The ongoing research may offer new treatment avenues for patients in urgent need.

Innovent Biologics has announced the successful achievement of primary endpoints in two Chinese registration studies for the recombinant full-human anti-PCSK-9 monoclonal antibody, IBI306. The CREDIT-1 and CREDIT-4 studies demonstrated significant reductions in LDL-C levels in patients with hypercholesterolemia. Following three completed key registration studies, Innovent plans to submit a new drug application for IBI306 targeting primary hypercholesterolemia and combined hyperlipidemia. These results emphasize the drug's potential in offering effective treatment options for cardiovascular disease risk in China.