March 29, 2022, Chengdu, China - Keymed Biosciences Inc. (HKEX Code: 02162) released 2021 annual results.
On July 8, 2021, Keymed was listed on the HKEX. During the Reporting Period, the Company continued proceeding the R&D of products and made the following progress with respect to pipeline and business operation:
Core product CM310 (IL-4Rα antibody):
▪ The Company has initiated and completed the Phase IIb clinical trial for moderate-to-severe AD in adults, with the results disclosed in November 2021. And the Phase III clinical study has been rapidly initiated in the first quarter of 2022.
▪ Phase II clinical trial for patients with CRSwNP was initiated in the first half of 2021 and the enrollment was completed in September 2021，and the results were disclosed in March 2022. The Company plans to initiate the Phase III study for CRSwNP in the second half of 2022.
Core product CM326 (TSLP antibody):
▪ The Company has initiated and completed the Phase I trial in healthy persons in 2021, with the results disclosed in November 2021.
▪ Phase Ib/IIa clinical trials of CM326 in adults with moderate to severe AD have been initiated in the first quarter of 2022.
▪ Phase Ib/IIa clinical trials in patients with CRSwNP are about to be initiated.
Core product CMG901 (Claudin 18.2 ADC):
▪ Phase I clinical trial of CMG901 in subjects with solid tumors was proceeded in 2021, which is currently in the dose-escalation phase. The Company expects to initiate the dose-expansion stage of trial in solid tumors in China in the second quarter of 2022.
▪ In March 2021, Keymed received the FDA IND clearance of CMG901 for the Phase I clinical trial in gastric and GEJ cancers in the U.S.
CM313 (CD38 antibody):
▪ The Phase I clinical trial for hematologic malignancies including RRMM and lymphoma was initiated and proceeded in 2021. The dose-escalation trial is expected to be completed in the first half of 2022.
▪ In January 2022, Keymed submitted a clinical trial application to the NMPA for the indication of CM313 in the treatment of SLE.
▪ By the end of 2021, the Company had more than 320 employees, including over 120 employees engaging in clinical development and operations.
▪ In addition to the headquarters in Chengdu, the Company has offices in Shanghai, Beijing, Wuhan, Guangzhou, etc.
▪ In 2021, the Company initiated the construction of a new plant in Chengdu, and the first production line is expected to be put into operation in mid-2022 with capacity of 16,000 L. The designs of all facilities are in compliance with the requirements of cGMP of the NMPA and FDA.
Actively cooperation with external parties
In 2021, Keymed entered into cooperation with CSPC in respect to the interests in China (excluding Hong Kong, Macau and Taiwan) of CM310 and CM326 in respiratory disease indications such as moderate-to-severe asthma and COPD. In September 2021, the Company strategically allied with CSPC to jointly identify, research, develop and commercialize one or more nervous system disease-related products.
In 2021, Keymed entered into a strategic collaboration agreement with InnoCare to develop first-in-class large-molecule innovative drugs.
▪ As of December 31, 2021, the Company’s R&D investment totaled RMB360 million; the collaboration income is RMB110 million, which was mainly derived from the cooperation with CSPC and InnoCare.
▪ As of December 31, 2021, the Company’s cash in hand is approximately RMB3.5 billion.