A Prospective, Single-Center, Open-Label, Randomized Clinical Study on the Treatment of Pemphigus With a Novel Humanized CD38 Monoclonal Antibody (CM313)

Pemphigus is characterized by the presence of IgG antibodies that lead to the loss of keratinocyte adhesion, resulting in blister formation. The etiology of pemphigus antibodies is multifactorial, involving immune dysregulation, genetic predisposition, and potential viral triggers. CD38, a multifunctional transmembrane glycoprotein, plays a crucial role in B-cell maturation and function. CM313, a novel humanized monoclonal antibody targeting CD38, has shown promise in clinical trials for autoimmune diseases, including refractory/relapsed multiple myeloma (RRMM), systemic lupus erythematosus (SLE), and immune thrombocytopenia (ITP). By binding to CD38 on B cells, CM313 modulates B-cell activation, proliferation, and differentiation, potentially reducing the production of autoantibodies, such as those against desmogleins 1/3 in pemphigus. Preclinical studies have demonstrated that CM313 effectively inhibits CD38 enzymatic activity through antibody-dependent cellular cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC), antibody-dependent cellular phagocytosis (ADCP), and Fc-mediated apoptosis. The long-term modulation of B-cell-mediated immune responses by CM313, through the depletion of both short-lived and long-lived plasma cells, suggests a novel therapeutic strategy for pemphigus by targeting the production of pathogenic autoantibodies.

Start Date01 Oct 2025

Sponsor / Collaborator

First Affiliated Hospital Of Fujian Medical University

NCT06594146 / Not yet recruitingPhase 1/2

A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Initial Efficacy of CM313 (SC) Injection in Patients With Primary Immune Thrombocytopenia

This is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial efficacy of CM313 (SC) injection in patients with primary immune thrombocytopenia.

Start Date30 Dec 2024

Sponsor / Collaborator

Keymed Biosciences, Inc.

CTR20240571 / RecruitingPhase 1

一项评价CM313在健康受试者中单次皮下注射/静脉输注给药、剂量递增的安全性、耐受性、药代动力学、药效学及免疫原性的随机、开放/双盲、安慰剂对照I期临床研究

[Translation] A randomized, open/double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of CM313 administered by single subcutaneous injection/intravenous infusion and dose escalation in healthy subjects

主要研究目的：评价CM313单次皮下注射给药或静脉输注给药在健康受试者中的安全性与耐受性；次要研究目的：评价CM313、rHuPH20单次皮下注射给药或静脉输注给药的药代动力学（PK）特征；评价CM313单次皮下注射给药或静脉输注给药的药效学（PD）特征；评价CM313、rHuPH20的免疫原性；

[Translation]

Main study objectives: To evaluate the safety and tolerability of CM313 administered by single subcutaneous injection or intravenous infusion in healthy subjects; Secondary study objectives: To evaluate the pharmacokinetic (PK) characteristics of CM313 and rHuPH20 administered by single subcutaneous injection or intravenous infusion; To evaluate the pharmacodynamic (PD) characteristics of CM313 administered by single subcutaneous injection or intravenous infusion; To evaluate the immunogenicity of CM313 and rHuPH20;

Start Date12 Mar 2024

Sponsor / Collaborator

Keymed Biomedical Technology (Chengdu) Co., Ltd.

100 Clinical Results associated with Lumrotatug

100 Translational Medicine associated with Lumrotatug

100 Patents (Medical) associated with Lumrotatug

Literatures (Medical) associated with Lumrotatug

20 Jun 2024·NEW ENGLAND JOURNAL OF MEDICINE

A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia

Article

Author: Chen, Yunfei ; Cao, Xuan ; Wang, Wentian ; Ma, Yueshen ; Yang, Renchi ; Liu, Xiaofan ; Li, Huiyuan ; Liu, Wei ; Wang, Yuhua ; Dai, Xinyue ; Sun, Ting ; Xue, Feng ; Chi, Ying ; Zhang, Lei ; Pei, Xiaolei ; Ju, Mankai ; Song, Zhen ; Dong, Huan ; Gu, Wenjing ; Fu, Rongfeng ; Xu, Yanmei

BACKGROUND:

Immune thrombocytopenia (ITP) is an autoimmune disease characterized by autoantibody-mediated platelet destruction. Treatment with CM313, a novel anti-CD38 monoclonal antibody, can result in targeted clearance of CD38-positive cells, including plasma cells.

METHODS:

We conducted a phase 1-2, open-label study to evaluate the safety and efficacy of CM313 in adult patients with ITP. CM313 was administered intravenously at a dose of 16 mg per kilogram of body weight every week for 8 weeks, followed by a 16-week follow-up period. The primary outcomes were adverse events and documentation of two or more consecutive platelet counts of at least 50×10⁹ per liter within 8 weeks after the first dose of CM313. The status of peripheral-blood immune cells in patients and changes in the mononuclear phagocytic system in passive mouse models of ITP receiving anti-CD38 therapy were monitored.

RESULTS:

Of the 22 patients included in the study, 21 (95%) had two consecutive platelet counts of at least 50×10⁹ per liter during the treatment period, with a median cumulative response duration of 23 weeks (interquartile range, 17 to 24). The median time to the first platelet count of at least 50×10⁹ per liter was 1 week (range, 1 to 3). The most common adverse events that occurred during the study were infusion-related reaction (in 32% of the patients) and upper respiratory tract infection (in 32%). After CD38-targeted therapy, the percentage of CD56^dimCD16+ natural killer cells, the expression of CD32b on monocytes in peripheral blood, and the number of macrophages in the spleen of the passive mouse models of ITP all decreased.

CONCLUSIONS:

In this study, anti-CD38 targeted therapy rapidly boosted platelet levels by inhibiting antibody-dependent cell-mediated cytotoxicity on platelets, maintained long-term efficacy by clearing plasma cells, and was associated with mainly low-grade toxic effects. (Funded by the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences and others; ClinicalTrials.gov number, NCT05694767).

Frontiers in Immunology

Preclinical characterization of a novel investigational monoclonal antibody CM313 with potent CD38-positive cell killing activity

Article

Author: Li, Yuling ; Yu, Juntao ; Liu, Wei ; He, Yanyun ; Xu, Gang ; Sun, Kaiwen ; Wang, Changyu ; Song, Qin ; Wang, Yanrong ; Chen, Bo

Introduction:

CM313 is currently under clinical investigation for treatments of multiple myeloma, systemic lupus erythematosus, and immune thrombocytopenia. We aimed to report the preclinical profile of the novel therapeutic anti-CD38 monoclonal antibody (mAb) CM313, with an emphasis on the difference with other CD38-targeting mAb.

Methods:

The binding of CM313 to CD38 recombinant protein across species was assessed using ELISA. The binding of CM313 to CD38-positive (CD38+) cells was detected using flow cytometry assays. CM313-induced complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP) and apoptosis on different CD38+ cells were assessed by LDH release assays or flow cytometry assays. The effect of CM313 on CD38 enzymatic activity was measured using fluorescence spectroscopy. CM313 immunotoxicity in human blood was assessed using flow cytometry assays, ELISA, and LDH release assays. Anti-tumor activity of CM313 was assessed in multiple mouse xenograft models. Safety profile of CM313 were evaluated in cynomolgus monkeys and human CD38 transgenic (B-hCD38) mice.

Results:

There exist unique sequences at complementarity-determining regions (CDR) of CM313, which facilitates its affinity to CD38 is consistently higher across a spectrum of CD38+ cell lines than daratumumab. In vitro studies showed that CM313 induces comparable killing activity than daratumumab, including ADCC, CDC, ADCP, apoptosis induced by Fc-mediated cross-linking, and effectively inhibited the enzymatic activity of CD38. However, CM313 showed more potent CDC than isatuximab. In vivo, CM313 dose-dependently inhibited xenograft tumor growth, both as a monotherapy and in combination with dexamethasone or lenalidomide. Furthermore, CM313 was well tolerated with no drug-related clinical signs or off-target risks, as evidenced by 4-week repeat-dose toxicology studies in cynomolgus monkeys and B-hCD38 mice, with the later study showing no observed adverse effect level (NOAEL) of 300mg/kg once weekly.

Discussion:

CM313 is a novel investigational humanized mAb with a distinct CDR sequence, showing comparable killing effects with daratumumab and stronger CDC activity than isatuximab, which supports its clinical development.

News (Medical) associated with Lumrotatug

27 Aug 2024

·www.prnewswire.com

Keymed Biosciences Announces Interim Results for First Half of 2024

CHENGDU, China , Aug. 27, 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 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. The study showed that at week 52, the rates of achieving EASI-75 and EASI-90 for the Stapokibart group was 92.5% and 77.1%, respectively. The rates of achieving an IGA score of 0 or 1 point with a reduction of ≥ 2 points from baseline was 67.3%. Long-term treatment with Stapokibart can consistently improve dermatitis symptoms and quality of life in subjects with moderate-to-severe AD. In terms of safety, Stapokibart was safe and well-tolerated after 52 weeks of administration, with safety profiles consistent with those observed at week 16 and no new safety signals identified. Advanced and completed the 52-week treatment and safety follow-up of the Phase III clinical study of Stapokibart injection for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in the first half of 2024. In June 2024, the new drug application of Stapokibart injection for the treatment of CRSwNP was accepted by the NMPA and granted priority review. Advanced and completed the unblinding of data and the statistical analysis of the Phase III clinical study of Stapokibart injection for the treatment of seasonal allergic rhinitis (SAR) in the first half of 2024, with the clinical data meeting the primary endpoints. In April 2024, the new drug application of Stapokibart injection for the treatment of SAR was accepted by the NMPA. 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 February 2024. Launched a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection 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. Among these, an international multi-center Phase III study comparing CMG901 (AZD0901) monotherapy versus investigator's choice as second-line or later-line treatment in patients with advanced or metastatic gastric and gastroesophageal junction (G/GEJ) cancer expressing Claudin 18.2 was publicly announced on the drug clinical trial registration and information publicity platform in March 2024. The first patient has received the initial dose in April 2024. 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 American Society of Clinical Oncology (ASCO) Annual Meeting 2024. The study results indicated that as of February 2024, among 89 evaluable patients with Claudin 18.2-high expressing (defined as Claudin 18.2 membrane intensity ≥2+ in ≥20% of tumor cells) G/GEJ cancer in three cohorts, confirmed objective response rate (ORR) and confirmed disease control rate (DCR) were 35% and 70%, respectively. In the 2.2 mg/kg dose group, the confirmed ORR was 48%. 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 multi-center, open-label, dose-escalation and dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CM313 injection in patients with RRMM, lymphoma, and other hematological malignancies. Continuously proceeded with a randomized, double-blinded, placebo-controlled, dose-escalation, multiple-dose Phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy 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. This is an investigator-initiated, single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of CM313 in adult patients with primary immune thrombocytopenia. 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 (interquartile range: 17-24). Additionally, 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% (14/22). In June 2024, we have submitted an IND application to further assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of CM313 in patients with primary immune thrombocytopenia. CM326 (TSLP antibody) In May 2024, we initiated a randomized, double-blinded, placebo-parallel Phase II clinical study to evaluate the efficacy and safety of CM326 in patients with CRSwNP, further exploring the optimal dosage. 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 in the first half of 2024 to assess the safety, tolerability, pharmacokinetics, and the preliminary anti-tumor activity of CM355 in relapsed or refractory non-Hodgkin's lymphoma (NHL). As of the date of this announcement, dose escalation of the intravenous infusion formulation (IV) was completed and the subcutaneous formulation (SC) is in the process of patient evaluation. CM336 (BCMAxCD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical study to assess the safety, tolerability, pharmacokinetics, and the anti-tumor activity of CM336 in RRMM. CM350 (GPC3xCD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CM350 in patients with advanced solid tumors. CM369/ICP-B05 (CCR8 antibody) Continuously proceeded with a Phase I clinical study in the first half of 2024 to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and relapsed or refractory NHL. CM383 (Aβ protofibrils antibody) Initiated a Phase I clinical study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single dose-escalation administration of CM383 in healthy subjects. The enrollment of the first subject was completed in June 2024. CM380 (GPRC5DxCD3 bispecific antibody) Submitted IND application, and planned to conduct a multi-center, open-label Phase I/II clinical study for evaluation of CM380 in treatment of patients with relapsed or refractory multiple myeloma. Financial and Business Highlights Actively carry out the out-licensing collaboration In July 2024, Chengdu Keymed and Belenos entered into an out-license agreement, which grants Belenos an exclusive right to develop, manufacture and commercialize the Group's drug candidates, CM512 and CM536, globally excluding the Greater China region. In return, Chengdu Keymed shall receive an upfront and nearterm payment of US$15 million, and iBridge HK Holdings Limited, a wholly-owned subsidiary of the Group, shall receive approximately 30.01% of the equity interest in Belenos as consideration. Subject to achievement of certain development, regulatory and commercial milestones, Chengdu Keymed may also receive additional payments of up to US$170 million. Chengdu Keymed is also entitled to receive tiered royalties from Belenos on net sales for a specified period of time commencing after the first commercial sale of CM512 and CM536. Expand manufacturing capacity and efficiently prepare for commercialization We continue to recruit talents to meet the growing needs of commercialization, research and development, clinical, production and operation of the Company. We further expanded our cGMP-compliant manufacturing capacity, efficiently prepared for the company to become a commercial organization. As of the date of this announcement, the production capacity of our production base has reached 18,600 litres in total, and all the designs thereof are in compliance with the requirements of cGMP of the NMPA and FDA. 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, from RMB 250 million for the six months ended June 30, 2023. 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. SOURCE Keymed

Phase 1Phase 3Phase 2Clinical ResultLicense out/in

20 Jun 2024

·www.prnewswire.com

Keymed Biosciences Announces Safety and Efficacy Results of CM313 for Primary Immune Thrombocytopenia Published in NEJM

CHENGDU, China, June 20, 2024 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) today announced that Lei Zhang/Renchi Yang's team from the Institute of Hematology, Chinese Academy of Medical Sciences has recently published a research paper entitled "A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia" in the New England Journal of Medicine. This is an investigator-initiated, single-arm, open-label phase I/II study evaluating the safety and preliminary efficacy of CM313 in adult patients with primary ITP. A total of 22 patients were enrolled in the study, with one patient dropping out after the first infusion. The remaining 21 patients completed both the 8-week treatment and 16-week follow-up periods. Results showed that 95.5% of patients (21/22) achieved a platelet count of ≥50 × 109/L during the 8-week treatment period, with a median cumulative response duration of 23 weeks (interquartile range, 17 to 24). The median time to first platelet count of ≥50 × 109/L was 1 week (range: 1-3), and the median time to first platelet count of ≥30 × 109/L with a ≥2-fold increase from baseline was 1 week. Additionally, the durable sustained 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% (14/22). Throughout the entire study, overall response (complete or partial response) was observed in 21 patients, with 20 patients achieving complete response. The proportion of patients with bleeding decreased from 68.2% (15/22) at baseline to 4.8 (1/21) at week 8. Most patients discontinued concomitant medications due to the restoration of platelet counts to normal or safe levels with CM313 treatment. In summary, CM313 demonstrated rapid and sustained efficacy in 95.5% of ITP patients who had previously received multiple therapies. Safety analyses showed that CM313 was well-tolerated. CM313 is a humanized monoclonal antibody targeting CD38 and the first domestically-developed anti-CD38 antibody with IND approval by the NMPA in China. Previous phase I/II studies have demonstrated the favorable safety profile and encouraging efficacy of CM313 in patients with RRMM and primary ITP. In addition, the potential use of CM313 in SLE is currently under clinical development. About Keymed Biosciences Inc. Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. To accelerate the efficiency of our research and discovery, the Company has established a fully-integrated platform encompassing all of the key functions in the biological drug development which include target validation, lead molecule discovery and optimization, preclinical evaluation, process development, translational research, clinical development and manufacturing. This integrated platform has enabled us to rapidly and cost-effectively identify, build, expand and advance our diversified pipeline of innovative and differentiated antibody-based therapies, including monoclonal antibodies, antibody drug conjugates (ADCs) and bispecific antibodies. SOURCE Keymed

Clinical ResultImmunotherapyIND

26 Mar 2024

·www.biospace.com

Keymed Biosciences Announces 2023 Annual Results and Business Updates

Submitted a New Drug Application (NDA) of Stapokibart (CM310) for the treatment of moderate-to-severe AD in adults. The NDA was accepted by the China's NMPA and granted priority review. Advanced a Phase III clinical study of Stapokibart for the treatment of CRSwNP in 2023. The results of the clinical trial are positive with co-primary endpoints both achieved. We expect to NDA for CRSwNP indication in 2024. Launched and advanced Phase III clinical studies respectively to evaluate the efficacy and safety of Stapokibart in patients with seasonal allergic rhinitis under background therapy and in adolescent subjects with moderate-to-severe AD. Entered into a global exclusive license agreement with AstraZeneca for the research, development, registration, manufacturing and commercialization of CMG901 and received an upfront payment of US$63 million in 2023. As of the date of this announcement, AstraZeneca has conducted multiple clinical studies regarding CMG901/AZD0901 for the treatment of advanced solid tumors. Rapidly expanded manufacturing capacity and continue to recruit talents to meet the growing needs of commercialized sales of products, research and development, clinical, production and operation of the Company. CHENGDU, China, March 26, 2024 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) today announced its 2023 annual results, along with recent pipeline highlights and corporate updates. "We made solid advances across our business in 2023 toward our goal to become a fully-integrated innovative biopharmaceutical company," said Dr. Bo Chen, Chairman, Executive Director, and Chief Executive Officer of Keymed Biosciences. "We successfully filed for NDA for Stapokibart (CM310), gaining priority review status, and have reported positive results from multiple clinical studies. We continued to develop our innovative and differentiated pipelines, actively explored value-accretive strategic partnerships, further expanded our cGMP-compliant manufacturing capacity and efficiently prepared for the company to become a commercial organization. The year 2024 is set to be an exciting one for Keymed, as the commercialization of our first product will propel us from being a clinical-stage biotech to a commercial-stage biopharmaceutical company. We will build on our plans to enable the successful launch of our product, as we continually strive to develop, manufacture and commercialize innovative biological therapies for patients worldwide." Pipeline Highlights The progress of core pipeline products: Stapokibart (CM310) (IL-4Rα antibody) Submitted a New Drug Application (NDA) of Stapokibart (CM310) for the treatment of moderate-to-severe AD in adults. The NDA was accepted by the China's NMPA and granted priority review. Launched a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart in adolescent subjects with moderate-to-severe AD in February 2024, and the patient enrollment is currently in progress. Advanced a Phase III clinical study of Stapokibart for the treatment of CRSwNP and completed the unblinding of data from the double-blind treatment period and the preliminary statistical analysis in December. The results of the Phase III clinical trial are positive with co-primary endpoints both achieved. We expect to NDA for CRSwNP indication in 2024. Launched and advanced a Phase III clinical study to evaluate the efficacy and safety of Stapokibart in patients with seasonal allergic rhinitis under background therapy in 2023, and a multi-center, single-arm Phase II clinical study to evaluate the safety of Stapokibart in patients with seasonal allergic rhinitis. Our partner, CSPC, has initiated the critical Phase II/III clinical study for the treatment of moderate-to-severe asthma, and the patient enrollment is currently in progress. CMG901/AZD0901 (Claudin 18.2 antibody conjugated) Entered into a global exclusive license agreement with AstraZeneca for the research, development, registration, manufacturing and commercialization of CMG901 and received an upfront payment of US$63 million in 2023. As of the date of this announcement, AstraZeneca has conducted multiple clinical studies regarding CMG901/AZD0901 for the treatment of advanced solid tumors. In November 2023, the latest data from Phase I clinical study of CMG901 in the treatment of advanced gastric/gastroesophageal junction (G/GEJ) cancer has been presented by way of oral presentation at the American Society of Clinical Oncology (ASCO) Plenary Series. Among 89 evaluable patients with claudin 18.2-positive G/GEJ cancer confirmed objective response rate (ORR) and confirmed disease control rate (DCR) were 33% and 70%, respectively. Among others,CMG901 showed a 42% confirmed ORR in 2.2 mg/kg dose cohort, with median progression free survival (mPFS) of 4.8 months. CM313 (CD38 antibody) Continuously proceeded with a Phase I clinical trial of CM313 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of CM313 monotherapy in hematological malignancies including relapsed/refractory multiple myeloma (RRMM) and lymphoma. In June 2023, we presented, in the form of a poster, the latest data from the Phase I clinical study of CM313 for the treatment of RRMM and relapsed/refractory lymphoma at the 28th European Hematology Association (EHA) Congress 2023. CM313 exhibited a good safety pro general in this study for it at dose levels of ≥2.0 mg/kg and yielded preliminary efficacy in patients with RRMM. Continuously proceeded with a Phase Ib/IIa clinical study in 2023 to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of CM313 injection in subjects with systemic lupus erythematosus (SLE). In December 2023, the latest data from the investigator-initiated single-arm, open-label, exploratory clinical study to evaluate CM313, which aimed to evaluate the safety and preliminary efficacy of CM313 for the treatment of primary immune thrombocytopenia in adults, were presented in a poster form at the 65th American Society of Hematology (ASH) Annual Meeting. As of June 30, 2023, a total of 21 patients were enrolled in the study. 7 subjects completed 8 treatments with follow-up period of more than 8 weeks. Among the 7 patients, 100.0% (7/7) achieved a platelet count ≥50 × 109/L within 8 weeks after administration with the first dose, with a median time to response of 1 week (range from 1 to 3). CM326 (TSLP antibody) Continuously proceeded with a Phase II clinical study to evaluate the efficacy and safety of CM326 in adult patients with moderate-to-severe AD. Continuously proceeded with a Phase Ib/IIa clinical trial to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, immunogenicity, and preliminary efficacy of CM326 in subjects with CRSwNP. Our partner, CSPC, has initiated the Phase II clinical study for the treatment of moderate-to-severe asthma. Progress of other pipeline products: CM355/ICP-B02 (CD20xCD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical trial to assess the safety, tolerability, PK, and the preliminary anti-tumor activity of CM355 in relapsed or refractory non-Hodgkin's lymphoma (r/r NHL). As of the date of this announcement, all the 13 patients who were treated CM355 at dose ≥6mg achieved response with the ORR of 100%. CM336 (BCMAxCD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical study in 2023 to assess the safety, tolerability, pharmacokinetics, and the anti-tumor activity of CM336 in RRMM. CM350 (GPC3xCD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical study in 2023 to assess the safety, tolerability, pharmacokinetics, and the preliminary efficacy of CM350 in patients with advanced solid tumors. CM338 (MASP-2 antibody) Continuously proceeded with a Phase II clinical study in 2023 to evaluate the efficacy and safety of CM338 injection in subjects with immunoglobulin A nephropathy (IgAN). CM369/ICP-B05 (CCR8 antibody) Continuously proceeded with a Phase I trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and relapsed or refractory NHL. We will explore the combination of CM369 with other immunotherapies in various cancer indications after collecting the safety data of monotherapy. CM383 (Aβ protofibrils antibody) Submitted an IND application for CM383 in February 2024, and we are about to conduct a Phase I clinical study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single dose-escalation administration in healthy subjects. Financial and Business Highlights Revenue amounted to RMB354 million for the year ended December 31, 2023, mainly representing collaboration income from AstraZeneca in respect of granting the relevant license; R&D expenses increased by RMB89 million to RMB596 million; As at December 31, 2023, our time deposits, cash and cash equivalents and bank wealth management products amounted to RMB2,719 million. The production capacity of the production base in Chengdu has reached 18,600 litres in total, and all the designs thereof are in compliance with the requirements of cGMP of the NMPA and FDA. Continue to recruit talents to meet the growing needs of commercialized sales of products, research and development, clinical, production and operation of the Company. About Keymed Biosciences Inc. Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. Keymed was founded by medical and scientific experts from world-renowned universities who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad. The core leadership team includes the inventors of the first PD-1 antibody drugs that were pioneered and approved in the United States and China. The Company was listed on the main board of Hong Kong Stock Exchange on July 8, 2021. To accelerate the efficiency of our research and discovery, we have established a fully-integrated platform encompassing all of the key functions in the biologic drug development. These include target validation, lead molecule discovery and optimization, preclinical evaluation, process development, translational research, clinical development and manufacturing. This integrated platform has enabled us to rapidly and cost-effectively identify, build, expand and advance our diversified pipeline of innovative and differentiated antibody-based therapies, including monoclonal antibodies, antibody drug conjugates (ADCs) and bispecific antibodies. For more information, please visit . Company Codes: HongKong:02162, HongKong:2162

Phase 1Clinical ResultPhase 3Phase 2License out/in

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Indication	Highest Phase	Country/Location	Organization	Date
Purpura, Thrombocytopenic, Idiopathic	Phase 2	CN	Keymed Biomedical Technology (Chengdu) Co., Ltd.	30 Aug 2024
Plasma cell myeloma refractory	Phase 2	-	Keymed Biomedical Technology (Chengdu) Co., Ltd.	28 Feb 2024
Multiple Myeloma	Phase 2	CN	Keymed Biomedical Technology (Chengdu) Co., Ltd.	17 Jan 2024
Systemic Lupus Erythematosus	Phase 2	CN	Keymed Biomedical Technology (Chengdu) Co., Ltd.	14 Oct 2022
Relapse multiple myeloma	Phase 1	CN	Keymed Biomedical Technology (Chengdu) Co., Ltd.	15 Apr 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05694767 (2022-I2M-2-003, N Engl J Med) Manual	Phase 1/2	Purpura, Thrombocytopenic, Idiopathic	22	CM313 16 mg/kg	ujxozpcexk(ztwsajnlwl) = The most common that occurred during the study were infusion-related reaction (in 32% of the patients) and upper respiratory tract infection (in 32%). czlzzolfbj (wgeojmwxdy )	Positive	19 Jun 2024
NCT05694767 (CM313, ASH2023)	Phase 2	Purpura, Thrombocytopenic, Idiopathic Second line	21	CM313	hwqrkcurbq(yjeatdfsle) = 6 (6/21, 28.6%) had an infusion-related reaction (IRR) at the first dose but none at subsequent doses. The severity of IRR was grade 1 or 2 (according to CTCAE version 5.0) ysspryurlp (fjhbwxdyrl )	Positive	09 Dec 2023
NCT04818372 (EHA2023)	Phase 1	Relapse multiple myeloma \| Lymphoma	34	CM313	hxogpdrdiy(xuyrbseaio) = Grade 3 or higher treatment-emergent adverse events (TEAEs) were reported in 15/34 (44.1%) pts (8 [23.5%] were considered drug related); there were no grade 5 TEAEs rdgusfzkai (csichxbpia ) View more	-	08 Jun 2023

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