Chengdu, China, March 18, 2023 (Reuters) /PRNewswire/ – CHENGDU, China, March 18, 2023 /PRNewswire/– Keymed Biosciences Inc. (HKEX: 02162) announced its 2022 full-year results. The Company focused on unmet clinical needs and continued to efficiently develop innovative and differentiated pipelines, proactively execute global strategic collaborations and accelerate its commercialization progressions in 2022.
Development of innovative and differentiated pipelines
Core product CM310 (IL-4Rα antibody):
- begin the Phase III pivotal clinical trial for adults with moderate to severe Alzheimer’s disease in the first quarter of 2022; Completion of patient enrollment in November 2022; The company plans to complete this study and submit the NDA for this indication in 2023.
- Release of Phase II clinical data for the treatment of CRSwNP in late March 2022: co-primary efficacy endpoints were fully met with positive results; begin the Phase-III-Study in the second half of 2022.
- Received the status of a from the CDE in June 2022 Therapiedurchbruchs (Breakthrough Therapy Designation BTD) for the treatment of moderate to severe Alzheimer’s disease.
- Received CDE IND approval for the treatment of AR in June 2022.
- Received FDA IND approval for the treatment of Alzheimer’s in August 2022.
- begin the clinical phase II/III registration study for moderate to severe asthma in March 2023 under the direction of CSPC.
Core product CM326 (TSLP antibody):
- Phase Ib/IIa clinical trial to begin in patients with moderate to severe Alzheimer’s disease in H1 2022; simultaneous initiation of the clinical phase II study for adults with moderate to severe Alzheimer’s disease in the second half of 2022.
- Start of the clinical phase Ib/IIa study for patients with CRSwNP in the second half of 2022; Completion of patient enrollment in February 2023.
Core product CMG901 (Claudin 18.2 ADC):
- Completion of patient enrollment for the Phase Ia dose-escalation clinical study in patients with solid tumors in H1 2022; Phase Ib dose-expansion clinical trial to begin in Q2 2022; patient recruitment for this study is ongoing.
- Received by the FDA in April 2022 Orphan Drug Designation and Fast Track Designation for the treatment of unresectable or metastatic cancer of the stomach and gastrointestinal tract.
- Received the in September 2022 from the CDE Status eines Therapiedurchbruchs (Breakthrough Therapy Designation, BTD) for the treatment of Claudin 18.2 positive advanced gastric cancer.
- Presentation of Phase Ia clinical data in patients with advanced solid tumors at ASCO GI 2023 in January 2023: Results showed that CMG901 was well tolerated and had a favorable safety profile; Preliminary efficacy results showed that in the 8 Claudin 18.2 positive gastric/GEJ cancer patients who received CMG901, the objective response rate (ORR) and disease control rate (DCR) were 75.0% and 100%, respectivelywhere the ORR 100 % was 2.6, 3.0 and 3.4 mg/kg in the cohorts.
- In February, KYM Biosciences Inc. (a 70% non-owned subsidiary of Keymed) entered into a worldwide exclusive license agreement with AstraZeneca AB, which will be responsible for the worldwide research, development, manufacturing and commercialization of CMG901. Under the terms of the agreement, KYM Biosciences will receive an upfront payment of $63 million and additional development and sales-related milestone payments of up to 1,1 Mrd. USD and tiered royalties in the low double digits.
Core product CM313 (CD38 antibodies):
- Phase Ia Escalation RRMM Clinical Trial to Continue in 2022; Dose escalation clinical study to begin in late-stage Q1 2022.
- Received IND approval for the treatment of SLE in China in April 2022; Completion of first patient dosing in October 2022; Phase Ib/IIa clinical trial ongoing.
Core product CM338 (MASP-2 antibody):
- Completion of Phase I clinical trial of CM338 in healthy volunteers in November 2022.
- Initiate Phase II clinical trial of CM338 for the treatment of IgAN in March 2023.
Other assets
CM355 (CD20xCD3):
- Completion of first patient dosing in January 2022; Phase I dose escalation study ongoing.
CM336 (BCMAxCD3):
- Completion of first patient dosing in September 2022; Phase I dose escalation study ongoing.
CM350 (GPC3xCD3):
- Received IND approval in China for the treatment of solid tumors in January 2022; Completion of first patient dosing in May 2022; Phase I dose escalation study ongoing.
CM369 (CCR8 antibodies):
- Received IND approval in China for the treatment of advanced tumors in August 2022; Completion of first patient dosing in January 2023; Phase I dose escalation study ongoing.
Enlargement of the team of talents and expansion of manufacturing capacities
- The company has built a stable core team and is continuously recruiting talent to meet growing needs in research and development, clinical trials, manufacturing, operations and commercialization. As of December 31, 2022, the company employs a total of 613 employeesbelow over 240 employees in clinical development and operations as well over 230 employees in production and quality control what a Increase of 189% over the previous year is equivalent to.
- In addition to the headquarters in Chengdu, the company has branches in Shanghai, Beijing, Wuhan, Guangzhou, Nanjing and Jinan.
- The construction of the first phase of the commercial plant, which has a production capacity of 16.000 liters will have been completed by the end of 2022. All facilities are designed in accordance with cGMP, NMPA and FDA requirements.
Financial data and capital market development
- As of December 31, 2022, the company’s R&D investments amounted to 500 million RMBwhat a increase of 42% compared to the previous year; the income amounted to 100 million RMB, derived from proceeds from CSPC’s out-licensing of CM326; the company has a total of 3,17 Mrd. RMB of liquid funds, time deposits and bank balances that can fully support the future development of the company.
- In March 2022, Keymed Bio (2162.HK) was added to the list of eligible stocks for the Shenzhen-Hong Kong Stock Connect. In August 2022, Keymed was included in the FTSE Global Small Cap Index ex US; in November 2022, Keymed was included in the MSCI China Small Cap Index.
About Keymed Biosciences Inc.
Keymed Biosciences Inc. (stock code: 02162 HK) focuses on addressing urgent unmet clinical needs and is committed to providing high quality, affordable and innovative therapies to patients in China and overseas. Keymed was founded by medical and scientific experts from world-renowned universities, who have extensive experience in translating scientific and technological achievements into commercial exploitation at home and abroad. Core to the leadership team are the inventors of the first PD-1 antibody drugs developed and approved in the United States and China. The company was listed on the Main Board of the Hong Kong Stock Exchange on July 8, 2021.
For more information, see www.Keymedbio.com.
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