On March 17, 2023 Keymed Biosciences Inc. (HKEX: 02162) reported its 2022 annual results (Press release, Keymed Biosciences, MAR 17, 2023, View Source;proactively-develops-global-strategic-collaboration-301775097.html [SID1234628997]). Focused on unmet clinical needs, the Company continued to efficiently develop innovative and differentiated pipelines, proactively carry out global strategic collaboration and accelerate its commercialization progress in 2022.
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Development of Innovative and Differentiated Pipelines
Core Product CM310 (IL-4Rα antibody):
Initiated Phase III registrational clinical trial for adults with moderate to severe AD in 2022 Q1; Completed the patient enrollment in 2022 November; The Company plans to complete this trial and submit the NDA for this indication in 2023.
Released Phase II clinical data for the treatment of CRSwNP in end of March 2022: co-primary efficacy endpoints are fully achieved with positive results; Initiated Phase III trial in 2022 H2.
Received Breakthrough therapy designation (BTD) from the CDE for the treatment of moderate to severe AD in June 2022.
Obtained the CDE IND approval for the treatment of AR in July 2022.
Obtained the FDA IND approval for the treatment of AD in August 2022.
Initiated Phase II/III pivotal clinical trial for moderate to severe asthma in March 2023, led by CSPC.
Core Product CM326 (TSLP antibody):
Initiated Phase Ib/IIa clinical trial for patients with moderate to severe AD in 2022 H1; Simultaneously initiated Phase II clinical trial for adults with moderate to severe AD in 2022 H2.
Initiated Phase Ib/IIa clinical trial for patients with CRSwNP in 2022 H2; Completed the patient enrollment in February 2023.
Core Product CMG901 (Claudin 18.2 ADC):
Completed the patients enrollment of Phase Ia dose-escalation clinical trial in subjects with solid tumor by 2022 H1; Initiated Phase Ib dose-expansion clinic trial in 2022 Q2 and patient enrollment for this trial is ongoing.
Received Orphan-drug Designation & Fast Track Designation for the treatment of unresectable or metastatic gastric and gastroesophageal junction cancer from the FDA in April 2022.
Received Breakthrough therapy designation (BTD) for the treatment of Claudin 18.2-positive advanced gastric cancer from the CDE in September 2022.
Presented Phase Ia clinical data in subjects with advanced solid tumor at the 2023 ASCO (Free ASCO Whitepaper) GI in January 2023: The results showed that CMG901 was well-tolerated with a favorable safety profile; Preliminary efficacy results demonstrated that in the 8 Claudin 18.2-positive gastric/GEJ cancer patients receiving CMG901, Objective response rate (ORR) and disease control rate (DCR) were 75.0% and 100%, respectively, with ORR of 100% in the 2.6, 3.0, and 3.4 mg/kg cohorts.
In February 2023, KYM Biosciences Inc. (a non-wholly owned subsidiary owned by Keymed with 70% shares) entered a global exclusive license agreement with AstraZeneca AB, who will be responsible for the research, development, manufacture, and commercialization of CMG901 globally. Under the terms of the agreement, KYM Biosciences will receive an upfront payment of $63m on transaction closing and additional development and sales-related milestone payments of up to $1.1bn as well as tiered royalties up to low double-digits.
Core Product CM313 (CD38 antibody):
Proceeding Phase Ia does-escalation clinical trial for RRMM in 2022; Initiated dose expansion clinical trial in the late stage of 2022 Q1.
Obtained IND approval for the treatment of SLE in China in April 2022; completed the first patient dosing in October 2022; Phase Ib/IIa clinical trial is ongoing.
Core Product CM338 (MASP-2 antibody):
Completed CM338 Phase I clinical trial with healthy volunteers in November 2022.
Initiated CM338 Phase II clinical trial for the treatment of IgAN in March 2023.
Completed the first patient dosing in January 2022; Phase I dose-escalation trial is ongoing.
Completed the first patient dosing in September 2022; Phase I dose-escalation trial is ongoing.
Obtained IND approval in China for the treatment of solid tumor in January 2022; Completed the first patient dosing in May 2022; Phase I dose-escalation trial is ongoing.
CM369 (CCR8 antibody):
Obtained IND approval in China for the treatment of advanced solid tumor in August 2022; Completed the first patient dosing in January 2023; Phase I dose-escalation trial is ongoing.
Enlarged Team of Talents & Expanded Manufacturing Capabilities
The Company has built a stable core team and continuously recruit talents to match its growing demand for R&D, clinical trial, manufacture, operation and commercialization. By December 31th 2022, the Company has a total of 613 employees, including over 240 employees in clinical development and operations, and more than 230 employees in production and quality control, with a year-over-year increase of 189%.
In addition to the headquarters in Chengdu, the Company has set offices in Shanghai, Beijing, Wuhan, Guangzhou, Nanjing, Jinan.
The construction of the first phase of commercial-scale facility has been completed by the end of 2022, which will provide 16,000L of manufacturing capacity. The design of all facilities is in compliance with the requirements of cGMP of the NMPA and FDA.
Financial Data & Capital Market Performance
As of December 31, 2022, the Company’s R&D investment amounted RMB 500 million, a year-over-year increase of 42%; Income amounted RMB 100 million, which comes from the out-licensing revenue of CM326 from CSPC; The Company holds a total of RMB 3.17 billion in cash and cash equivalents, time deposits and bank wealth management, which can fully support the Company’s future development.
In March 2022, Keymed Bio (2162.HK) was included as eligible stocks of the Shenzhen-Hong Kong Stock Connect. In Aug 2022, Keymed got listed in FTSE Global Small Cap Index ex US; In Nov 2022, Keymed got listed in MSCI China Small Cap Index.