Keymed Biosciences Announces Interim Results for First Half of 2024

CHENGDU, China, Aug. 28, 2024 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) today announced its interim results for the first half of 2024, along with a corporate update.

Rapid development of our pipeline products

Stapokibart (CM310) (IL-4Ra antibody)

• In June 2024, the long-term efficacy and safety data from the Phase III clinical trial of Stapokibart for the treatment of moderate-to-severe AD were presented by way of oral presentation at the EAACI 2024. The study showed that long-term treatment with Stapokibart can consistently improve dermatitis symptoms and quality of life in subjects with moderate-to-severe AD.
• In June 2024, the NDA of Stapokibart for the treatment of CRSwNP was accepted by the NMPA and granted priority review.
• In April 2024, the NDA of Stapokibart for the treatment of SAR was accepted by the NMPA.
• Launched a Phase III clinical study of Stapokibart in adolescent subjects with moderate-to-severe AD in February 2024.
• Launched a Phase III clinical study of Stapokibart in prurigo nodularis subjects in May 2024.
• Our partner CSPC initiated the critical Phase II/III clinical study for the treatment of moderate-to-severe asthma and moderate-to-severe COPD.

CMG901/AZD0901 (Claudin 18.2 ADC)

• As of the date of this announcement, AstraZeneca has conducted multiple clinical studies regarding CMG901 (AZD0901) for the treatment of advanced solid tumors.
• In June 2024, the latest data from a Phase I clinical study of CMG901 (AZD0901) in the treatment of advanced G/GEJ cancer were presented by way of oral presentation at the ASCO Annual Meeting 2024. The study results indicated that the median progression free survival (mPFS) for all 93 patients with Claudin 18.2-high expressing G/GEJ cancer was 4.8 months, and the median overall survival (mOS) was 11.8 months.

CM313 (CD38 antibody)

• Continued to advance a Phase I clinical study of CM313 injection in patients with RRMM, lymphoma, and other hematological malignancies.
• Continuously proceeded with a Phase Ib/IIa clinical study of CM313 injection in subjects with SLE.
• In June 2024, a research paper titled "A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia" was published in The New England Journal of Medicine. The results showed that 95.5% of patients (21/22) achieved a platelet count of =50 × 10⁹/L within 8 weeks upon the first acceptance of CM313 infusion, with a median cumulative duration for a platelet count of =50 × 10⁹/L of 23 weeks.
• Submitted an IND application to further assess CM313 in patients with primary immune thrombocytopenia in June 2024.

CM326 (TSLP antibody)

• Initiated a Phase II clinical study of CM326 in patients with CRSwNP in May 2024.
• Our partner CSPC initiated the Phase II clinical study for the treatment of moderate-to-severe asthma.

CM355/ICP-B02 (CD20xCD3 bispecific antibody)

• Continuously proceeded with a Phase I/II clinical trial of CM355 in relapsed or refractory NHL.

CM336 (BCMAxCD3 bispecific antibody)

• Continuously proceeded with a Phase I/II clinical study of CM336 in RRMM.

CM350 (GPC3xCD3 bispecific antibody)

• Continuously proceeded with a Phase I/II clinical study of CM350 in patients with advanced solid tumors.

CM369/ICP-B05 (CCR8 antibody)

• Continuously proceeded with a Phase I clinical study of CM369 in subjects with advanced solid tumors and relapsed or refractory NHL.

CM383 (Aß protofibrils antibody)

• Initiated a Phase I clinical study of CM383 in healthy subjects.

CM380 (GPRC5DxCD3 bispecific antibody)

• Submitted IND application, and planned to conduct a Phase I/II clinical study for evaluation of CM380 in treatment of patients with RRMM.

Financial and Business Highlights

• In July 2024, Chengdu Keymed granted Belenos an exclusive right to develop, manufacture and commercialize the Group's drug candidates, CM512 and CM536, globally excluding the Greater China region.
• Production capacity of our production base has reached 18,600 litres in total.
• Financial highlights: As of June 30, 2024, the Company held cash (including bank wealth management products) of RMB 2.58 billion. R&D expenses of the Group increased by RMB 81 million to RMB 331 million. During the Reporting Period, the Group's revenue amounted to RMB 54.6 million, mainly consisted of the 1st milestone revenue from AZ on the CMG901 license transaction.

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