Jul 9, 2022 | Business
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
Jun 17, 2022 | Business
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, today announced that, the first healthy subject has been dosed in the Phase I clinical trial of SM17 in the U.S. SM17 is a First-in-Class (FIC) humanized anti-IL-17RB monoclonal antibody. The subject is currently in a normal condition.
SM17 is the world’s first humanized IgG4-k monoclonal antibody targeting IL-17RB. SM17 is currently under development by SinoMab, and was engineered by LifeArc (a leading medical research charity based in the United Kingdom). SM17 was originally developed by Dr. Andrew McKenzie, FRS, who also serves as a member of the Company’s Scientific Advisory Board, at the MRC Laboratory of Molecular Biology (LMB).
SM17 could suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s), 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 airway viral responses and allergic diseases, such as uncontrolled severe asthma. Uncontrolled severe asthma is associated with increased mortality/ morbidity, diminished quality of life and increased health expenditures. These patients are at a risk of recurrent asthma exacerbations and hospitalizations. The Company expected that targeting upstream mediators of the Th2 inflammatory cascade, such as IL-17RB on ILC2s, will have a broad effect on airway inflammation. The Company believes the huge potential of SM17 could satisfy unmet medical needs in asthma treatment. The Phase I study is a Single Ascending Dose (SAD) and Multiple Ascending Doses (MAD) to investigate the safety, tolerability and pharmacokinetics of SM17 in healthy subjects.
SM17 received Investigational New Drug (IND) approval from U.S. Food and Drug Administration (FDA) on 11 March 2022. Despite the pandemic, SinoMab have soon initiated the first-in-human dose in the Phase I clinical trial. This marks a significant milestone on the collaboration between SinoMab and LifeArc, and demonstrates the efficient implementation of SinoMab’s new drug R&D programs.
Melanie Lee, Chief Executive Officer of LifeArc, said: “We applied our antibody capabilities when working with Dr. Andrew McKenzie at the LMB, to firstly generate and select a clinical candidate antibody targeting IL-17RB, and then humanise it. After evaluating and choosing the lead candidate, it was licensed to SinoMab to take forward into clinical development and towards patients. It’s so rewarding to know that this antibody is going into trials and could eventually make a difference to people with severe asthma.”
Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: “SM17’s successful first-in-human dosing in Phase I clinical trial marked another milestone in our pipeline development. Following our flagship product, SM03 and key product, SN1011, we now have another key asset entering the clinical trial stage. This further assures our potential commercialization prospects and proves our capability for progressing multiple assets of R&D concurrently. We are confident of the enormous prospects for SM17’s clinical development as well as our commercialization opportunities in general. Moving forward, we will accelerate implementation of our projects, adhere to our vision of independent innovation to bring benefits to patients and create value for shareholders.”
About LifeArc
LifeArc is a self-financing and leading UK medical research charity. It partners and works with academics, industry, charities and patient groups to unlock the potential of early stage science. It has an office in London and scientific research facilities in Stevenage and Edinburgh. It also has a specialist science team working at the Francis Crick Institute in London.
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 vulgaris (PV), non-Hodgkin’s lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.
Topic: Press release summary
Jun 9, 2022 | Business
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, on 6 June 2022, an Investigational New Drug application (“IND”, for neuromyelitis optica spectrum disorder (“NMOSD”)) for SN1011 has been filed with and accepted by the Center for Drug Evaluation (the “CDE”) of the National Medical Products Administration of China (the “NMPA”). The Company plans to initiate the Phase II clinical study in China upon approval of the present IND. The present IND submission, once granted, will enable the Company to conduct clinical program in China for treatment of NMOSD.
SN1011 is the Company’s third generation, covalent reversible BTK inhibitor with improved safety, higher selectivity and superior efficacy and for the long-term treatment of systemic lupus erythematous, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market in terms of mechanism of action, affinity, selectivity and safety.
The Phase I clinical study (first-in-human clinical trial) of SN1011 was conducted in Australia and China in 2019 and completed in July 2021, which has demonstrated improved safety and good pharmacokinetics profile. Currently, the IND application for SN1011 in the treatment of systemic lupus erythematosus (SLE), pemphigus vulgaris (PV) and multiple sclerosis (MS) have been approved by NMPA, the Company plans to launch the Phase II clinical study of SN1011 for pemphigus in the third quarter of 2022. The Company is also planning an IND submission for multiple sclerosis (MS) in the U.S. in the second quarter of 2022, thereby accelerating the initiation of a global phase II trial in the third quarter of 2022.
NMOSD is an autoimmune-mediated inflammatory demyelinating disease of the central nervous system with predominant involvement of the optic nerve and spinal cord. The pathogenesis of NMOSD is mainly associated with aquaporin-4 (AQP4) antibodies and is a separate disease entity from multiple sclerosis, with severe optic neuritis and longitudinal extensive transverse myelitis as the main clinical features. However, the cause of NMOSD is unknown, with a combination of environmental factors such as smoking, low vitamin D levels, EBV infection and genetic susceptibility contributing to the development of the disease.
In 2020, according to inpatient registration data published in China, the incidence of NMOSD is about 0.278 (100,000 people/year), with children at 0.075 (100,000 people/year) and adults at 0.347 (100,000 people/year). NMOSD is seen at all ages, with young adults being the most common, with the average age of onset being 40 years. NMOSD is a highly recurrent and disabling disease, with 40-60% of patients experiencing a recurrence within one year and 90% within three years, and 50% of patients with a natural course of the disease having severe visual or motor impairment within 5-10 years. Currently, there are only three drugs officially approved by the US FDA or the European Union for the treatment of NMOSD, including complement inhibitors, IL-6 receptor blockers and B-lymphocyte-depleting agents. On 30 April 2021, the NMPA officially approved satralizumab for treatment of AQP4-IgG positive patients over the age of 12 years, making it the first drug approved for NMOSD treatment indications in mainland China. An IND application for NMOSD for SN1011 of SinoMab has been accepted by the CDE of the NMPA, and once approved, will facilitate the clinical research and development of new drugs for NMOSD in China.
Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: “NOMSD is the fourth indication of SN1011 in China following the approvals of IND application for systemic lupus erythematosus (SLE), pemphigus vulgaris (PV) and multiple sclerosis (MS), and is also the third IND application submitted by the Company to the regulatory authority this year, which fully reflects the team’s ability to simultaneously advance the research and development of multiple drug candidates and to effectively execute and communicate. The potential indications for SN1011 continue to expand, BTK inhibitor has a wide range of applications in the field of treatment of autoimmune diseases and huge future market potential. We believe that if the SN1011 product is successfully approved and commercialized in the future, it is expected to bring positive benefits to the Company, provide new options for the treatment of various autoimmune diseases and bring hope to the majority of patients.”
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 vulgaris (PV), non-Hodgkin’s lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.
Topic: Press release summary
Feb 8, 2022 | Business
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, on 21 January 2022, an Investigational New Drug application (“IND”, for multiple sclerosis) for SN1011 has been filed with and accepted, on 28 January 2022, by the Center for Drug Evaluation (the “CDE”) of the National Medical Products Administration of China (the “NMPA”). The Company plans to initiate the Phase II clinical study in China upon approval of the present IND. 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 multiple sclerosis.
SN1011 is the Company’s third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy and improved safety for the long-term treatment of systemic lupus erythematous, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety.
Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: “after the Company announced earlier the Completion of Enrollment in Phase III Clinical Trial in China for its Flagship Product, SM03, an IND application (for multiple sclerosis) for SN1011 has been filed with and accepted by the Center for the CDE of the NMPA, which will accelerate the progression of the Phase II clinical study and clinical development program related to indication for treatment of multiple sclerosis, fully reflecting the Company’s efficient implementation of new drug R&D programs. We are absolutely confident in the enormous prospects of SN1011’s clinical development. In the future, the Company will accelerate the program to further expand its product pipeline and strive to bring benefits to patients.”
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 vulgaris (PV), non-Hodgkin’s lymphoma (NHL), asthma, and other diseases with major unmet clinical needs.
Topic: Press release summary
Nov 30, 2021 | Business
SinoMab BioScience Limited (“SinoMab”, or the “Company”, 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, on 30 November 2021, SM03 (Suciraslimab) Phase III clinical trial for rheumatoid arthritis (RA) has completed its targeted enrollment of 510 patients. The patients currently in screening will be randomized by end of December 2021, given eligibility criteria are met.
SM03 (Suciraslimab), a potential global first-in-target anti-CD22 monoclonal antibody for the treatment of RA and potentially for the treatment of other immunological diseases, is currently in Phase III clinical trials in China. The Phase III clinical trial is a multi-center, randomized, double-blind, placebo-controlled, parallel group study to confirm the clinical efficacy and long-term safety in active RA patients receiving methotrexate (MTX).
The efficacy and safety of Suciraslimab was previously evaluated in a phase II clinical study in moderate-to-severely active RA patients. The study results were published recently and shown that Suciraslimab at a dose of 600 mg with 4 and 6 infusions respectively, were both efficacious and well-tolerated throughout the 24 weeks of treatment when compared with the placebo group. Suciraslimab was effective in suppressing disease activity and alleviates symptoms of moderate-to-severely active RA patients receiving stable doses of background MTX.
Dr. Shui On LEUNG, Executive Director, Chairman and Chief Executive Officer of the Company, said, “After the Company announced the results of the flagship product, SM03, which is efficacious and well-tolerated earlier, the completion of enrolment in phase III clinical trial is a major milestone in the research and development process; with the smooth progression of the clinical trial, SM03 will soon step into commercialization officially.”
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 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, systemic lupus erythematosus, pemphigus vulgar, non-Hodgkin’s lymphoma, asthma, and other diseases with major unmet clinical needs.
Topic: Press release summary
