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-4Rα 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 (Aβ 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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