SinoMab Announces that IND Application of SM17 for the Treatment of Asthma was Approved by NAMP

A Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases- SinoMab BioScience Limited (Stock Code: 3681.HK, “SinoMab” or the “Company”), is pleased to announce that the Investigational New Drug (“IND”) application, for the treatment of patients with asthma for the Company’s First-in-Class (FIC) therapeutic product SM17, was approved by the National Medical Products Administration of China (the “NMPA”) on 11 August 2023. The Company plans to conduct a Phase I clinical study in China soon to investigate the safety profile of SM17 in Chinese population and to initiate the clinical development program of SM17 for the treatment of allergic diseases.

SM17 is a novel, first-in-class, humanized, IgG4-k monoclonal antibody which is capable of modulating Type II allergic reaction by targeting the receptor of a critical “alarmin” molecule interleukin 25 (IL-25). SM17 could suppress Th2 immune responses by binding to IL-25 receptor (also known as IL-17RB) on Type 2 Innate Lymphoid cells (ILC2s), and Type 2 helper T (Th2) cells, blocking a cascade of responses induced by IL-25, and suppressing the release of the downstream Th2 cytokines such asIL-4, IL-5 and IL-13. IL-25 is a critical cytokine classified as “alarmin”, which has shown to be implicated in the pathogenesis of multiple airway viral responses and allergic diseases, such as asthma. Patients with severe, uncontrolled asthma are at risk of recurrent asthma exacerbations and hospitalizations, and uncontrolled severe asthma is associated with increased mortality and morbidity, diminished quality of life and increased health expenditures.

Meanwhile, the Company is also advancing the Phase I clinical study of SM17 in the U.S. at full speed. Based on the current progress, the Company expects to complete the Phase I clinical study by the end of this year, half a year ahead of the anticipated completion date. As early as March 2022, SM17’s IND application for the treatment of asthma was approved by the U.S. Food and Drug Administration (“FDA”), and the first healthy subject had been successfully dosed in a Phase I clinical First-in-Human(FIH) clinical trial in June 2022. As of today, none of the subjects reported a serious adverse event.

As a new pathway for asthma treatment, therapy targeting the upstream mediators of the Th2 inflammatory cascade pathway, such as “alarmin”, is expected to have a broad effect on airway inflammation. This is expected to lead to more effective control of asthma symptoms and an improvement in disease conditions compared to existing therapies. This has also been validated in the clinical trial of SM17.

The potential first-in-target antibody of SM17 has demonstrated the potential efficacy for multiple indications, including asthma and IPF (Idiopathic Pulmonary Fibrosis). The above unique mechanism enables SM17 to cover more diversified indications, which can not only target indications with huge market size such as asthma and atopic dermatitis, but also treat diseases with high mortality rate such as IPF, and continuously expand its indication coverage. Compared with other currently approved therapeutic antibody drugs targeting ILC2s downstream pathway, SM17 has a differentiated advantage at the source.

As one of the global pandemics, asthma has caused social problems, with huge and urgent medical needs that cannot be ignored. The number of asthma patients worldwide is increasing year by year, and a large patient base is in urgent need of effective therapeutic drugs to alleviate unmet medical needs. According to the Frost & Sullivan Report, the number of asthma patients worldwide is expected to increase to approximately 860 million in 2030, of which the number of asthma patients in China will increase to 78.1 million which is higher than the global growth rate. The Company expects that targeting upstream mediators of the Th2 inflammatory cascade, such as the receptor for IL-25, will have a broad effect on airway inflammation, which is expected to provide a new therapeutic channel with efficacy and safety for asthma diseases and bring relief and treatment to asthma patients.

Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of SinoMab said that: “SM17’s IND application for the treatment of asthma has been approved three months after it was accepted by the NMPA, which demonstrates that the efficient execution of the Company’s new drug R&D program is well recognized by the NMPA, and also fully reflects the huge potential of SM17 in unmet medical needs for asthma treatment. We are confident in the huge clinical development and commercialization prospects of SM17, and will accelerate the progress of clinical trials and strive to achieve commercial business as soon as possible in the future. At the same time, we continue to expand the scope of indications so that new treatment options can benefit more Chinese patients in the future. The Company will continue to focus on autoimmune diseases, and spare no effort to provide more effective treatment options for Chinese and global patients with abundant technical reserves and strong innovation capabilities.”

About SinoMab BioScience Limited
SinoMab BioScience Limited is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The R&D headquarters is located in Hong Kong and the production base is located in mainland China. The Company’s flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and has completed the Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), Alzheimer’s disease, systemic lupus erythematosus (SLE), pemphigus (PV), multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), non-Hodgkin’s lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.

This press release is issued by Financial PR (HK) Limited on behalf of SinoMab BioScience Limited. For further information, please contact:

Financial PR (HK) Limited
Contact: Ms. Chloe Chiu / Ms. Serena Zhang / Ms. Willa Xue
Email: sinomab@financialpr.hk
Tel: (852) 2610 0846
Fax: (852) 2610 0842


Topic: Press release summary

SinoMab Submits another IND Application for SM17 for the Treatment of Atopic Dermatitis, Which was Accepted by NMPA CDE

A Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases – SinoMab BioScience Limited (Stock Code: 3681.HK, “SinoMab” or the “Company”), is pleased to announce that an Investigational New Drug application (“IND”) for SM17, a humanised anti-IL-17RB monoclonal antibody for injection, for atopic dermatitis (“AD”) , has been filed with and accepted by the Center for Drug Evaluation (“CDE”) of the National Medical Products Administration of China (“NMPA”). The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of AD.

SM17 is a humanized, IgG4-k monoclonal antibody targeting IL-17RB, which is a global first-in-class monoclonal antibody drug targeting IL-17BR with the potential for treating atopic dermatitis, asthma, idiopathic pulmonary fibrosis and other immunological disorders. The IND is mainly for the treatment of AD, and the Company will initiate a Phase I clinical study in China upon approval of the present IND.

SM17 could suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s) and Type 2 helper T (Th2) cells, blocking a cascade of responses induced by interleukin-25 (IL-25). IL-25 is a critical cytokine classified as “alarmin”, which has shown to be implicated in the pathogenesis of autoimmune and inflammatory skin diseases, especially for AD. Around the globe, about one-fifth of the population were affected by AD at a certain stage of life, especially during the period of children. The condition is extremely volatile and can be difficult to be totally cured. It significantly reduces the quality of life of patients, and requires highly effective products to make up for unmet medical needs.

As a long-standing chronic disease, new cases of AD are growing rapidly in China with broad market potential. According to Frost & Sullivan, there were approximately 65.7 million AD patients in China in 2019 and is expected to grow to 81.7 million in 2030, and 30% of which will be moderate-to-severe patients. China’s AD medicine market was US$600 million in 2019, and is expected to grow to US$1.5 billion in 2024, and is expected to increase to US$4.3 billion in 2030, indicating a considerable market size. We expect that targeting upstream mediators of the Th2 inflammatory cascade, such as IL-17RB, will have a broad effect on skin inflammation. Coupled with the vast market potential of AD market and the lack of effective treatment methods, it is believed that the research and development of its treatment has market potential.

The Company is also committed to advancing multiple indications studies for SM17, laying a foundation for proof of concept and drug launches. In the United States, as early as March 2022, SM17’s IND application for the treatment of asthma was approved by the U.S. Food and Drug Administration (“FDA”), and the first healthy subject had been successfully dosed in a Phase I clinical First-in-Human(“FIH”) clinical trial in June 2022. Since then, none of the subjects reported a serious adverse event. At present, we are in full steam ahead to accelerate the progress of our clinical study, and expect the Phase I clinical study can be completed by the end of this year, six months ahead of the original anticipated completion date. In China, in addition to the acceptance of the application of SM17 for the treatment of AD, the new drug application for the treatment of asthma was also accepted by NMPA CDE on May 19 this year. If approved, the phase I clinical trial will be accelerated.

Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of SinoMab said that, “As a global first-in-class humanised IgG4-k monoclonal antibody targeting IL-17RB, SM17 has made good progress in several new drug research with the Company’s proactive progress. The acceptance of the new drug application for SM17 not only helps the Company to carry out the clinical research and development project for the treatment of AD in China, but also reflects the high efficiency of the research and development of new drugs. The Company is confident in the significant clinical trial and commercial development prospects of the new drug of SM17, and expects that the new treatment option will benefit more Chinese patients in the future, to jointly write a new chapter in the treatment of AD. In addition, the Company will continue to insist on independent innovation, strive to improve the research of new drugs, continuously expand the indication population, and provide more effective treatment solutions for patients in China and worldwide with no efforts, with an aim to become a global leader in innovative therapies for immunological diseases.”

About SinoMab BioScience Limited
SinoMab BioScience Limited is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The R&D headquarters is located in Hong Kong and the production base is located in mainland China. The Company’s flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and has completed the Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), Alzheimer’s disease, systemic lupus erythematosus (SLE), pemphigus (PV), multiple sclerosis (MS), neuromyelitis optica spectrum disorder (NMOSD), non-Hodgkin’s lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.

This press release is issued by Financial PR (HK) Limited on behalf of SinoMab BioScience Limited. For further information, please contact:

Financial PR (HK) Limited
Contact: Ms. Chloe Chiu / Ms. Serena Zhang / Ms. Cita Zhang / Ms. Willa Xue
Email: sinomab@financialpr.hk
Tel: (852) 2610 0846
Fax: (852) 2610 0842


Topic: Press release summary

SinoMab Announces IND Application of SM17 for the Treatment of Asthma was Accepted by NMPA CDE

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SinoMab Announces Appointment of Mr. Shanchun WANG as the President (China) of the Company

SinoMab BioScience Limited (“SinoMab” or the “Company”, together with its subsidiaries, the “Group”, stock code: 3681.HK), a Hong Kong-based biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases, is pleased to announce that, Mr. Shanchun WANG has been appointed as the President (China) of the Company. Mr. Wang will mainly be responsible for the China operation.

Mr. Shanchun WANG, served as the executive director of Sino Biopharmaceutical Limited (stock code: 1177) and the president of Chia Tai – Tianqing Pharmaceutical Group Co. Ltd., joined SinoMab lately as the President (China) of the Company. Mr. Shanchun WANG has rich experience and practical achievements in corporate strategic management, organizational management, innovation research and development and product commercialization. He is a specialist that granted the special government allowances of the State Council and awarded as a national model worker, a Jiangsu Province Technology Advanced Worker, a Jiangsu Province Model Labour, a winner of the Shanghai Technology Advancement First Honour Award, a Jiangsu Province Outstanding Entrepreneur, a Jiangsu Province Young and Middle-aged Expert with Outstanding Contribution, a Jiangsu Advanced Individual with Outstanding Contribution in Manufacture etc.

Mr. Shanchun WANG said that: “Under the leadership of Dr. Shui On LEUNG, SinoMab has gathered a very strong R&D force, forged a unique B-cell therapeutic platform, and prospectively launched a pipeline with a series of potential key products, with truly internationally recognized original innovation strength. At the same time, SinoMab’s dedication to the field of autoimmune diseases and its vision of growing into a global leader in novel treatments of immunological diseases is highly consistent with the development model of my service enterprises in the past, which is also an important reason why I chose to join SinoMab.”

Dr. Shui On LEUNG said that: “It is a great pleasure to have Mr. Shanchun WANG joining the Company. Our Group has been engaging extensively in the field of autoimmune disease and with the mission of growing into a global leader in the novel treatments of immunological diseases. We have a strong research and development capabilities. Leveraging on our Group’s B-cell therapeutic platform, Alarmins-pathway therapeutic platform and selective T-cell therapeutic platform, the Group has a strategic plan in expanding and diversifying our product pipeline. We believe that Mr. Wang’s rich experience in the pharmaceutical industry for more than 30 years, and as one of the leaders in the biotech industry in China, will help expediting the Company’s development from a global drug research and development enterprise to a biopharmaceutical company bearing commercialization capabilities and international perspective. Mr. Wang’s engagement as the President (China) of the Company while also subscribing shares of the Company also reflects the confidence and commitment of Mr. Wang and our senior management towards the long-term and sustainable growth of the Group, and the continuous support of our senior management will be beneficial to the long-term business development of the Group.”

The Company entered into a subscription agreement with Mr. Wang earlier. Pursuant to the subscription agreement, Mr. Shanchun WANG conditionally agreed to subscribe for and the Company conditionally agreed to allot and issue 14,340,000 subscription shares. This reflects his confidence and commitment towards the long-term and sustainable growth of the Group.

About SinoMab BioScience Limited

SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company’s flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for rheumatoid arthritis in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus, non-Hodgkin’s lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.






Topic: Press release summary



SinoMab Received the Highest Subsidy from HKSTP

SinoMab BioScience Limited (“SinoMab” or the “Company”, together with its subsidiaries, the “Group”, stock code: 3681.HK), a Hong Kong-listed biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of innovative therapeutics for the treatment of immunological diseases, primarily mAb-based biologics, is pleased to announce that, the Company has received HK$8 million subsidy from the Hong Kong Science and Technology Parks Corporation (“HKSTP”), which is the highest subsidy amount in the Clinical Translational Catalyst (CTC) program of HKSTP.

CTC program is offered by HKSTP Institute for Translational Research (ITR), the overarching aim is to provide a platform to transform Hong Kong and Greater Bay Area to become the go-to destination for translational medicine in the region. Under this program, funding support will be provided to biomedical companies of HKSTP to bring innovative, life-changing therapies and technologies to patients.

SinoMab stood out from many biopharmaceutical companies in the CTC program and was granted the highest subsidy amount, embodying the recognition by the evaluation committee on the Company’s product candidates and research and development (R&D) plan. According to the agreement signed by both parties, HKSTP will provide SinoMab a subsidy of HK$8 million in the next 42 months in phases according to its clinical plan and progress for the clinical study of SN1011, the Company’s key product, for the treatment of multiple sclerosis (MS).

SN1011 is SinoMab’s key product and third-generation covalent reversible Bruton’s tyrosine kinase (BTK) inhibitor. Following the approval of Investigational New Drug (IND) applications of SN1011 for systemic lupus erythematosus (SLE) and pemphigus vulgaris (PV) by the National Medical Products Administration (NMPA) on 27 August 2020 and 23 June 2021, respectively, the IND application of SN1011 for MS has been approved by the NMPA on 19 April 2022. The Company plans to initiate Phase II clinical study to evaluate the efficacy and safety of SN1011 in patients with MS in China and expects to enroll the first patient in the fourth quarter of 2022. The IND application of SN1011 for neuromyelitis optica spectrum disorder (NMOSD) was also accepted by the Center for Drug Evaluation (CDE) of the NMPA on 6 June 2022.

Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: “By launching the CTC program, HKSTP provides great support to local biopharmaceutical companies on their New Drug R&D. As a biopharmaceutical company raised in Hong Kong for 20 years, we are grateful for the long-term support and assistance of the HKSTP in promoting innovation and development of local biopharmaceutical companies. Previously, President Xi Jinping, and the Chief Executive of the HKSAR, Mr. Lee Ka-chiu, visited the Science Park, with the desire to forge Hong Kong into an international Innovation and Technology hub, demonstrating the country’s high appreciation of Hong Kong innovative technology development. We are excited by the unprecedented opportunities. With the smooth progress of clinical trials of the Company’s key candidates, the subsidy from the HKSTP will provide a solid foundation for the Company’s continuous R&D and stepping toward commercialization. We will fully grasp the opportunity to accelerate the R&D and clinical trials of various products, further expand the product pipeline and potential indications, speed up the realization of product commercialization, adhere to the concept of independent innovation, strive for the well-being of patients and create value for shareholders.”

About Hong Kong Science and Technology Parks Corporation
Established in 2001, HKSTP attracts and nurtures talent, accelerates and commercializes innovation and technology for entrepreneurs on their journey of growth in Hong Kong, to the Greater Bay Area, Asia and beyond. Its growing innovation ecosystem is built around its key locations of the Hong Kong Science Park in Shatin, InnoCentre in Kowloon Tong and three modern INNOPARKs in Tai Po, Tseung Kwan O and Yuen Long. The three INNOPARKs are realizing a vision of re-industrialisation for Hong Kong. The goal is sectors like advanced manufacturing, electronics and biotechnology are being reimagined for a new generation of the industry.

Through its infrastructure, services, expertise and network of partnerships, HKSTP will help establish innovation and technology as a pillar of growth for Hong Kong, while reinforcing Hong Kong’s international I&T hub status as a launchpad for global growth at the heart of the GBA innovation powerhouse.

About SinoMab BioScience Limited
SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases. The Company’s flagship product SM03 is a potential global first-in-target mAb against CD22 for the treatment of rheumatoid arthritis (RA) and is currently in Phase III clinical trial for RA in China, which has been recognized as one of the significant special projects of Significant New Drugs Development of the Twelfth Five-Year Plan Period and the Thirteenth Five-Year Plan Period. In addition, the Company possesses other potential first-in-target and first-in-class drug candidates, some of which are already in clinical stage, with their indications covering rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), pemphigus vulgaris (PV), non-Hodgkin’s lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.






Topic: Press release summary