Submitted a New Drug Application (NDA) of Stapokibart (CM310) for the treatment of moderate-to-severe AD in adults. The NDA was accepted by the China’s NMPA and granted priority review.
Advanced a Phase III clinical study of Stapokibart for the treatment of CRSwNP in 2023. The results of the clinical trial are positive with co-primary endpoints both achieved. We expect to file an NDA for CRSwNP indication in 2024.
Launched and advanced Phase III clinical studies respectively to evaluate the efficacy and safety of Stapokibart in patients with seasonal allergic rhinitis under background therapy and in adolescent subjects with moderate-to-severe AD.
Entered into a global exclusive license agreement with AstraZeneca for the research, development, registration, manufacturing and commercialization of CMG901 and received an upfront payment of US$63 million in 2023. As of the date of this announcement, AstraZeneca has conducted multiple clinical studies regarding CMG901/AZD0901 for the treatment of advanced solid tumors.
Rapidly expanded manufacturing capacity and continue to recruit talents to meet the growing needs of commercialized sales of products, research and development, clinical, production and operation of the Company.
CHENGDU, China, March 26, 2024 /PRNewswire/ — Keymed Biosciences Inc. (HKEX: 02162) today announced its 2023 annual results, along with recent pipeline highlights and corporate updates.
“We made solid advances across our business in 2023 toward our goal to become a fully-integrated innovative biopharmaceutical company,” said Dr. Bo Chen, Chairman, Executive Director, and Chief Executive Officer of Keymed Biosciences. “We successfully filed for NDA for Stapokibart (CM310), gaining priority review status, and have reported positive results from multiple clinical studies. We continued to develop our innovative and differentiated pipelines, actively explored value-accretive strategic partnerships, further expanded our cGMP-compliant manufacturing capacity and efficiently prepared for the company to become a commercial organization. The year 2024 is set to be an exciting one for Keymed, as the commercialization of our first product will propel us from being a clinical-stage biotech to a commercial-stage biopharmaceutical company. We will build on our plans to enable the successful launch of our product, as we continually strive to develop, manufacture and commercialize innovative biological therapies for patients worldwide.”
Pipeline Highlights
The progress of core pipeline products:
Stapokibart (CM310) (IL-4Rα antibody)
Submitted a New Drug Application (NDA) of Stapokibart (CM310) for the treatment of moderate-to-severe AD in adults. The NDA was accepted by the China’s NMPA and granted priority review.
Launched a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart in adolescent subjects with moderate-to-severe AD in February 2024, and the patient enrollment is currently in progress.
Advanced a Phase III clinical study of Stapokibart for the treatment of CRSwNP and completed the unblinding of data from the double-blind treatment period and the preliminary statistical analysis in December. The results of the Phase III clinical trial are positive with co-primary endpoints both achieved. We expect to file an …