Keymed Biosciences Announces Annual Results of 2024

PR Newswire

CHENGDU, China, March 26, 2025

CHENGDU, China, March 26, 2025 /PRNewswire/ -- March. 25, 2025, Keymed Biosciences Inc. (HKEX: 02162) announced its annual results of 2024, along with a corporate update.

Rapid development of our pipeline products

Stapokibart (CM310) (IL-4R<ALPHA> antibody)

Three new drug applications of Stapokibart for the treatment of moderate-to-severe atopic dermatitis (AD) in adults, chronic rhinosinusitis with nasal polyposis (CRSwNP) and seasonal allergic rhinitis have been approved by the NMPA. By the end of 2024, Stapokibart resisted strong sales and recorded revenue of approximately RMB40 million within three and a half months.

   -- In September 2024, the new drug application of Stapokibart injection for 
      the treatment of moderate-to-severe atopic dermatitis in adults was 
      approved by the NMPA. The phase III clinical study results indicated that 
      at week 52, the rates of achieving EASI-75 for the Stapokibart group and 
      the placebo-to-Stapokibart group were 92.5% and 88.7%, respectively. The 
      EASI-90 response rates were 77.1% and 65.6%, respectively. The rates of 
      achieving an IGA score of 0 or 1 point with a reduction of >= 2 points 
      from baseline were 67.3% and 64.2%, respectively. Additionally, the rates 
      of achieving a weekly average reduction of >= 4 points from baseline in 
      the daily PP-NRS score were 67.3% and 60.5%, respectively. Long-term 
      treatment with Stapokibart can consistently improve dermatitis symptoms 
      and quality of life in subjects with moderate-to-severe AD. During the 
      maintenance period, only one subject (0.9%) experienced a relapse. 
 
   -- In December 2024, the new drug application of Stapokibart injection for 
      the treatment of chronic rhinosinusitis with nasal polyps was approved by 
      the NMPA. The study results showed that the data from the Phase III 
      clinical trial was positive. Compared to the placebo, Stapokibart 
      significantly reduced nasal polyps (NPS improvement of 2.3 from baseline) 
      and alleviated nasal congestion (NCS improvement of 0.7 from baseline) 
      after 24 weeks. The differences were highly statistically significant (P 
      < 0.0001). Additionally, it effectively relieved rhinosinusitis, restored 
      sense of smell, improved nasal symptoms, and enhanced quality of life. 
 
   -- In February 2025, the new drug application of Stapokibart injection for 
      the treatment of seasonal allergic rhinitis was approved by the NMPA. We 
      advanced and completed the data unblinding and statistical analysis for 
      the Phase III clinical study of Stapokibart injection for the treatment 
      of seasonal allergic rhinitis $(SAR)$. The study findings demonstrate that 
      during the pollen season, in comparison with the standard treatment group, 
      which consists of nasal spray hormones combined with antihistamine drugs, 
      the administration of Stapokibart for two weeks effectively controls the 
      typical nasal allergic symptoms of patients, including runny nose, nasal 
      congestion, nasal itching, and sneezing. The least-squares mean (LSMean) 
      of the inter-group difference is -1.3, and its 95% confidence interval 
      $(CI)$ is also -1.3, indicating a highly significant statistical difference 
      (P = 0.0008). This difference far exceeds the minimal clinically 
      important difference (MCID) of 0.23, clearly demonstrating substantial 
      clinical benefits. Moreover, Stapokibart can effectively alleviate ocular 
      allergic symptoms such as eye itching or burning, eye tearing or watering, 
      and eye redness. It comprehensively enhances the quality of life of 
      patients and exhibits excellent safety. 
 
   -- In February 2024, we launched a randomized, double-blinded, 
      placebo-controlled Phase III clinical study to evaluate the efficacy and 
      safety of Stapokibart injection in adolescent subjects with 
      moderate-to-severe AD. 
 
   -- In May 2024, we initiated a randomized, double-blinded, 
      placebo-controlled Phase III clinical study to evaluate the efficacy and 
      safety of Stapokibart injection in subjects with nodular prurigo. As of 
      the date of this announcement, the patient enrollment for this clinical 
      study is in progress. 
 
   -- In June 2024, the long-term efficacy and safety data from the Phase III 
      clinical trial of Stapokibart injection for the treatment of 
      moderate-to-severe AD were presented by way of oral presentation at the 
      European Academy of Allergy and Clinical Immunology (EAACI) Congress 
      2024. 
 
   -- In October 2024, the full text of the 52-week efficacy and safety data of 
      the Phase III clinical study was published in the Allergy , the top 
      international journal in allergy and immunology field. 
   -- CMG901/AZD0901 (Claudin 18.2 ADC)AstraZeneca has conducted multiple 
      clinical studies regarding CMG901 (AZD0901) for the indications of 
      gastric cancer, pancreatic cancer and biliary tract cancer, including the 
      Phase III clinical trial for 2L+ gastric cancer, Phase II clinical trial 
      for 1L gastric cancer, Phase II clinical trial for 1L pancreatic cancer, 
      and Phase II clinical trial for 2L+ biliary tract cancer. 
 
   -- In June 2024, the data from the Phase I clinical study of CMG901 
      (AZD0901) in the treatment of advanced G/GEJ cancer were presented by way 
      of oral presentation at the American Society of Clinical Oncology (ASCO) 
      Annual Meeting 2024. On 6 January 2025, the data from the Phase I 
      clinical study was released on the international authoritative oncology 
      journal, The Lancet Oncology. The clinical data 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)

   -- In 2024, we initiated and advanced a multi-center, open-label Phase I/II 
      clinical study. 
 
   -- 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. 95.5% of patients achieved a platelet count 
      of >=50 × 109/L within 8 weeks upon the first acceptance of CM313 
      infusion, and the durable platelet count response rate (defined as a 
      platelet count of >=50 × 109/L observed six or more times among the 
      final eight platelet counts) was 63.6%. 
 
   -- In July 2024, we completed Phase Ib/IIa clinical study to evaluate the 
      safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity 
      and preliminary efficacy of CM313 injection in subjects with SLE. We plan 
      to initiate a Phase II clinical study in the first half of 2025. 
 
   -- In 2024, we initiated a randomized, double-blinded, placebo-controlled 
      Phase II clinical study to evaluate the safety, tolerability, 
       pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary 
      efficacy of CM313(SC) injection in subjects with primary immune 
      thrombocytopenia. The first patient was enrolled and dosed in November 
      2024. 
 
   -- We initiated a randomized, double-blinded, placebo-controlled Phase II 
      clinical study to evaluate the safety and efficacy of CM313(SC) injection 
      in subjects with IgA nephropathy in early 2025. As of the date of this 
      announcement, preparations for patient enrollment are underway for this 
      study. 

CM512 (TSLP x IL-13 bispecific antibody)

   -- We have initiated a randomized, double-blinded, single/multiple 
      dose-escalation, placebo-controlled Phase I clinical study to evaluate 
      the safety, tolerability, pharmacokinetics, pharmacokinetics and 
      immunogenicity of CM512 in healthy subjects and patients with 
      moderate-to-severe atopic dermatitis, with enrollment of the first 
      subject completed in September 2024. The overseas Phase I clinical trial 
      evaluating CM512 for the treatment of asthma was initiated in the first 
      quarter of 2025. 

CM336 (BCMAxCD3 bispecific antibody)

   -- Continuously proceeded with a multi-center, open-label Phase I/II 
      clinical study to assess CM336 injection in treating patients with 
      relapsed or refractory multiple myeloma. As of the date of this 
      announcement, the product is currently in the dose-expansion phase of 
      Phase I/II clinical study. 
 
   -- In December 2024, the latest data of the phase I/II clinical study of 
      CM336 for relapsed or refractory multiple myeloma was presented as a 
      poster at the 66th American Society of Hematology $(ASH)$ Annual Meeting. 

CM383 (A<BETA> protofibrils antibody)

   -- As of the date of this announcement, the enrollment of all subjects in 
      the Phase Ia clinical study of CM383 in healthy subjects was completed; 
 
   -- In November 2024, the enrollment of the first subject in Phase Ib 
      clinical study of CM383 in patients with mild cognitive dysfunction of 
      Alzheimer's disease origin and mild Alzheimer's disease was completed. 

CM518D1 (CDH17 ADC)

   -- We submitted IND application to CDE, and planned to conduct a 
      multi-center, open-label Phase I/II clinical trial for evaluation of 
      CM518D1 in treatment of patients with advanced solid tumors. 

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March 26, 2025 11:09 ET (15:09 GMT)