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 27, 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 NDA for CRSwNP indication in 2024. Launched and advanced a Phase III clinical study to evaluate the efficacy and safety of Stapokibart in patients with seasonal allergic rhinitis under background therapy in 2023, and a multi-center, single-arm Phase II clinical study to evaluate the safety of Stapokibart in patients with seasonal allergic rhinitis. Our partner, CSPC, has initiated the critical Phase II/III clinical study for the treatment of moderate-to-severe asthma, and the patient enrollment is currently in progress.
CMG901/AZD0901 (Claudin 18.2 antibody conjugated)
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. In November 2023, the latest data from Phase I clinical study of CMG901 in the treatment of advanced gastric/gastroesophageal junction (G/GEJ) cancer has been presented by way of oral presentation at the American Society of Clinical Oncology (ASCO) Plenary Series. Among 89 evaluable patients with claudin 18.2-positive G/GEJ cancer confirmed objective response rate (ORR) and confirmed disease control rate (DCR) were 33% and 70%, respectively. Among others,CMG901 showed a 42% confirmed ORR in 2.2 mg/kg dose cohort, with median progression free survival (mPFS) of 4.8 months.
CM313 (CD38 antibody)
Continuously proceeded with a Phase I clinical trial of CM313 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of CM313 monotherapy in hematological malignancies including relapsed/refractory multiple myeloma (RRMM) and lymphoma. In June 2023, we presented, in the form of a poster, the latest data from the Phase I clinical study of CM313 for the treatment of RRMM and relapsed/refractory lymphoma at the 28th European Hematology Association (EHA) Congress 2023. CM313 exhibited a good safety profile in general in this study for it at dose levels of ≥2.0 mg/kg and yielded preliminary efficacy in patients with RRMM. Continuously proceeded with a Phase Ib/IIa clinical study in 2023 to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of CM313 injection in subjects with systemic lupus erythematosus (SLE). In December 2023, the latest data from the investigator-initiated single-arm, open-label, exploratory clinical study to evaluate CM313, which aimed to evaluate the safety and preliminary efficacy of CM313 for the treatment of primary immune thrombocytopenia in adults, were presented in a poster form at the 65th American Society of Hematology (ASH) Annual Meeting. As of June 30, 2023, a total of 21 patients were enrolled in the study. 7 subjects completed 8 treatments with follow-up period of more than 8 weeks. Among the 7 patients, 100.0% (7/7) achieved a platelet count ≥50 × 109/L within 8 weeks after administration with the first dose, with a median time to response of 1 week (range from 1 to 3).
CM326 (TSLP antibody)
Continuously proceeded with a Phase II clinical study to evaluate the efficacy and safety of CM326 in adult patients with moderate-to-severe AD. Continuously proceeded with a Phase Ib/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, immunogenicity, and preliminary efficacy of CM326 in subjects with CRSwNP. Our partner, CSPC, has initiated the Phase II clinical study for the treatment of moderate-to-severe asthma.
Progress of other pipeline products:
CM355/ICP-B02 (CD20xCD3 bispecific antibody)
Continuously proceeded with a Phase I/II clinical trial to assess the safety, tolerability, PK, and the preliminary anti-tumor activity of CM355 in relapsed or refractory non-Hodgkin’s lymphoma (r/r NHL). As of the date of this announcement, all the 13 patients who were treated CM355 at dose ≥6mg achieved response with the ORR of 100%.
CM336 (BCMAxCD3 bispecific antibody)
Continuously proceeded with a Phase I/II clinical study in 2023 to assess the safety, tolerability, pharmacokinetics, and the anti-tumor activity of CM336 in RRMM.
CM350 (GPC3xCD3 bispecific antibody)
Continuously proceeded with a Phase I/II clinical study in 2023 to assess the safety, tolerability, pharmacokinetics, and the preliminary efficacy of CM350 in patients with advanced solid tumors.
CM338 (MASP-2 antibody)
Continuously proceeded with a Phase II clinical study in 2023 to evaluate the efficacy and safety of CM338 injection in subjects with immunoglobulin A nephropathy (IgAN).
CM369/ICP-B05 (CCR8 antibody)
Continuously proceeded with a Phase I trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and relapsed or refractory NHL. We will explore the combination of CM369 with other immunotherapies in various cancer indications after collecting the safety data of monotherapy.
CM383 (Aβ protofibrils antibody)
Submitted an IND application for CM383 in February 2024, and we are about to conduct a Phase I clinical study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single dose-escalation administration in healthy subjects.
Financial and Business Highlights
Revenue amounted to RMB354 million for the year ended December 31, 2023, mainly representing collaboration income from AstraZeneca in respect of granting the relevant license; R&D expenses increased by RMB89 million to RMB596 million; As at December 31, 2023, our time deposits, cash and cash equivalents and bank wealth management products amounted to RMB2,719 million. The production capacity of the production base in Chengdu has reached 18,600 litres in total, and all the designs thereof are in compliance with the requirements of cGMP of the NMPA and FDA. Continue to recruit talents to meet the growing needs of commercialized sales of products, research and development, clinical, production and operation of the Company.
About Keymed Biosciences Inc.
Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. Keymed was founded by medical and scientific experts from world-renowned universities who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad. The core leadership team includes the inventors of the first PD-1 antibody drugs that were pioneered and approved in the United States and China. The Company was listed on the main board of Hong Kong Stock Exchange on July 8, 2021.
To accelerate the efficiency of our research and discovery, we have established a fully-integrated platform encompassing all of the key functions in the biologic drug development. These include target validation, lead molecule discovery and optimization, preclinical evaluation, process development, translational research, clinical development and manufacturing. This integrated platform has enabled us to rapidly and cost-effectively identify, build, expand and advance our diversified pipeline of innovative and differentiated antibody-based therapies, including monoclonal antibodies, antibody drug conjugates (ADCs) and bispecific antibodies.
For more information, please visit www.keymedbio.com.
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