INNOVENT BIOLGCS UNSP/ADR - IVBIY STOCK NEWS

Innovent Biologics and IASO Biotherapeutics announced the acceptance of the New Drug Application (NDA) for Equecabtagene Autoleucel by the China National Medical Products Administration (NMPA). This CAR-T therapy targets relapsed and/or refractory multiple myeloma (R/R MM) and is the first of its kind developed in China. The therapy showed a 94.9% overall response rate in a clinical study. This acceptance comes after the therapy received Breakthrough Therapy Designation in February 2021 and may lead to significant advancements in treatment options for MM patients.

Innovent Biologics has presented preliminary data from a Phase I clinical trial of IBI351 (GFH925), a KRAS^G12C inhibitor, at the 2022 ASCO Annual Meeting. Conducted on 31 patients with advanced solid tumors, the trial highlighted a promising 42.9% overall response rate (ORR) and favorable tolerability. Among 12 non-small cell lung cancer patients receiving higher doses, the ORR was 50%. Notably, IBI351 exhibited no dose-limiting toxicities, with most treatment-related adverse events being mild. The study indicates potential for IBI351 in treating KRAS^G12C mutated cancers in China.

Innovent Biologics has appointed Mr. Gary Zieziula as an independent non-executive director and member of the audit and strategy committees. Zieziula brings over 40 years of global experience in pharmaceuticals, previously leading Kyowa Kirin USA and EMD Serono. His expertise in drug commercialization is expected to complement Innovent's strategy during a crucial growth phase, as the company aims to enhance its global footprint. Innovent, established in 2011, has developed a robust pipeline with 32 assets, including 7 marketed products in China.

Innovent Biologics announced its participation in the 2022 ASCO annual meeting, showcasing clinical data from various trials involving innovative treatments like IBI110, Pemazyre, and others. Key studies include the efficacy of IBI110 in HER2-negative gastric cancer and advanced lung cancer, highlighting promising preliminary results. Additionally, an updated Phase II study on Pemazyre for cholangiocarcinoma was also presented. This event underscores Innovent's commitment to advancing oncology solutions while enhancing patient care.

Innovent Biologics announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation for IBI310, in combination with sintilimab, for treating recurrent or metastatic cervical cancer. The designation is based on Phase 2 trial results involving 205 patients, showing a safety profile consistent with previous studies. This designation will facilitate expedited development and review of IBI310, which aims to address the urgent need for better treatment options in this patient population.

Innovent Biologics announced results from a Phase I study of IBI322, an anti-CD47/PD-L1 bispecific antibody, at the AACR Annual Meeting 2022. The study involved 58 patients with advanced solid tumors, with 20 patients evaluated. Results showed a 20% objective response rate (ORR) among patients treated with doses ≥10 mg/kg, including a 33.3% ORR in non-small cell lung cancer (NSCLC) patients. IBI322 was well tolerated, with treatment-related adverse events occurring in 74.1% of participants, primarily mild. The promising data support further exploration in a Phase Ib trial.

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.