Innovent Biologics, Inc. (“Innovent”, HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced that the results of the Phase 1 study in Chinese patients with advanced solid tumors were released today at the American Society for Clinical Oncology (ASCO) Annual Meeting 2021.

This is a Phase 1 study to evaluate the pharmacokinetic (PK), pharmacodynamic (PD) and safety of pemigatinib in Chinese patients (pts) with advanced malignancy. Moreover, potential efficacy of pemigatinib was explored in a broad spectrum of fibroblast growth factor receptor (FGFR) alteration in variety of cancer types. 12 patients with 5 different cancer types (colorectal cancer, gastric cancer, cholangiocarcinoma, esophageal carcinoma and breast cancer) and FGF/FGFR1-3 alterations were enrolled. All the subjects were failed to prior standard therapy. As of Jan 31, 2021, all patients received at least once treatment, the safety was controllable with the most common treatment related adverse events (TRAE) of hyperphosphatemia, decreased appetite and diarrhea. Two patients reported ≥ grade 3 TRAEs, which were hyponatremia and proteinuria. There were no TEAEs leading to death or treatment discontinuation. Among 11 efficacy evaluable patients, 2 of them had partial responses (PR) as evaluated by investigators with 1 cholagiocarcinoma harboring FGFR2 point mutation (p.F276C) and the other esophageal carcinoma carrying FGFR1 mutation (p.A354V). 3 patients had a best overall response of stable disease (SD). The objective response rate (ORR) was 16.7% (95%CI: 2–48%) and disease control rate was 41.7% (95%CI: 15–72%).

Professor Yi Ba from Tianjin Medical University Cancer Institute and Hospital said,” Pemigatinib had an acceptable and manageable toxicity in Chinese patients with advanced malignancy. A significant implication of the data is that it extended the population that potentially benefit from pemigatinib other than FGFR2 fusion/rearrangement.”

“Several FGFR inhibitors are being in clinical stage” said Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics. “Innovent has multiple clinical trials of pemigatinib for the treatment of cholangiocarcinoma and other types of tumors. Currently we are preparing the New Drug Application (NDA) of pemigatinib in China. We presented the data at the ASCO Annual Meeting, which highlighted our capability of small molecules. In the future, we will conduct in-depth clinical development of pemigatnib to explore its treatment in other indications. We are looking forward to providing innovative therapies for more cancer patients in the future.”

About Pemazyre® (pemigatinib)

In April 2020, the U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre® (pemigatinib), a selective, oral inhibitor of FGFR isoforms 1, 2 and 3, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is marketed by Incyte in the United States, Europe and Japan.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in Mainland China, Hong Kong, Macau and Taiwan.

Pemazyre is a trademark of Incyte Corporation.

About Innovent

Inspired by the spirit of “Start with Integrity, Succeed through Action,” Innovent’s mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, autoimmune, metabolic diseases, and other major therapeutic areas. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. By leveraging this platform, the company has built a robust pipeline of 24 valuable assets in major therapeutic areas, with 4 products officially approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection) and HALPRYZA® (rituximab biosimilar injection), one Biologics License Application (BLA) submission for sintilimab accepted by the U.S. FDA, six assets in Phase 3 or pivotal clinical trials, and 14 more molecules in clinical trials. TYVYT® (sintilimab injection) was included in the National Reimbursement Drug List (NRDL) in 2019 as the historically first PD-1 inhibitor entering in NRDL and the only PD-1 included in the list in that year.

Innovent has built an international team of advanced talented professionals in high-end biopharmaceutical development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with all relevant parties to help advance China’s biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients’ lives. For more information,

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