HONG KONG, Dec 19, 2022 – (ACN Newswire via SEAPRWire.com) – 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 the Company was awarded the “Most Valuable Pharmaceutical and Medical Company” at the “7th Hong Kong Golden Stocks Awards Ceremony” held in Hangzhou today.
The “Most Valuable Pharmaceutical and Medical Company” award aims to recognize Hong Kong-listed pharmaceutical and medical companies that have a healthy corporate governance structure, prominent industry status, sound governance structure, good main business, and the ability to provide investors with sustainable and stable values. SinoMab was awarded the “Most Valuable Pharmaceutical and Medical Company”, highlighting the attention and recognition of the industry and investors on the Company’s value and innovation capabilities, which is a great encouragement and even a spur to SinoMab.
SinoMab is the first Hong Kong-based listed biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapeutics, primarily monoclonal antibody (“mAb”)-based biologics, for the treatment of immunological diseases. With R&D headquarter in Hong Kong and production base in China, the Company strives to become a leading global biopharmaceutical company for the development of novel drugs to fulfil unmet medical needs through its Hong Kong-based innovative R&D, and PRC-based manufacturing capabilities.
Currently, various candidate products for all-field indications of autoimmune diseases in SinoMab’s layout have started clinical trials successively and are progressing steadily. In particular, SM03 (Suciraslimab), the Company’s flagship product, is a potential global first-in target mAb for the treatment of rheumatoid arthritis (“RA”) and other immunological diseases such as Alzheimer’s disease (“AD”), systemic lupus erythematosus (“SLE”), Sjogren’s syndrome (“SS”) as well as non-Hodgkin’s lymphoma (“NHL”). The Phase III clinical trial of SM03 for treatment of RA completed its enrollment on 31 December 2021, and is expected to complete the last subject visit (FV) in December 2022, read out clinical data in the first quarter of 2023 and submit a New Drug Application (“NDA”) to the National Medical Products Administration (the “NMPA”) of the People’s Republic of China (“PRC”) for commercialization in the second half of 2023 at the earliest.
Under normal operation of the human immune system, the B-cell receptor (BCR) pathway would be activated and create strong signals in response to foreign (“non-self”) antigens and trigger a series of B-cell immune responses. To differentiate from our “self” antigens, our body would recruit molecules, like SHP-1, to inhibit or reduce BCR-induced signaling, thereby suppressing B-cell immune responses. SM03 can be used to recruit such immunosuppressive molecules as SHP-1 by conversion of cis-binding CD22 to trans-binding CD22, forming a stable CD22 trans-binding structure, thereby restoring the tolerance of B cells to our “self” antigens and inhibiting a series of immune responses of B cells to attack our “self” antigens, thus suppressing relevant immune responses.
Most of the mechanisms of action of existing RA therapies will result in the depletion or death of B cells, which can have a series of side effects on the human autoimmune system. In contrast, SM03 suppresses the autoimmune response by regulating the function of B cells and does not damage the B-cells and does not affect the normal function of B-cells in the immune system. Data from the Phase II clinical trial showed that SM03 has a comparable response rate and a significant safety advantage over competing products currently available on the market.
In addition, SN1011, a key product of the Company, has obtained four IND approvals from the NMPA for the treatment of SLE, pemphigus (“PV”), multiple sclerosis (“MS”), neuromyelitis optica spectrum disorder (“NMOSD”) respectively. At the same time, the Company is planning an IND submission for MS in the U.S. SM17 (a humanized anti-IL-7RB monoclonal antibody for injection), another key product of the Company, its first healthy subject had been successfully dosed in a Phase I First-in-Human (FIH) clinical trial in the U.S. in June this year and the subjects are currently in normal condition.
Previously, SinoMab appointed Mr. Shanchun WANG as the President (China) of the Company, mainly responsible for the China operation. Mr. Wang has rich experience in the pharmaceutical industry for more than 30 years, served as the executive director of Sino Biopharmaceutical Limited and the president of Chia Tai – Tianqing Pharmaceutical Group Co. Ltd., and is a specialist that granted the special government allowances of the State Council and awarded as a national model worker. 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 Mr. Wang’s service enterprises in the past. As one of the leaders in the biopharmaceuticals enterprise in China with rich experience and practical achievements in corporate strategic management, organizational management, innovation research and development and product commercialization, Mr. Wang’s engagement as the President (China) of the Company 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.
Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: “The Company is deeply honored to be awarded the “Most Valuable Pharmaceutical and Medical Company” in the selection of the “7th Hong Kong Golden Stocks Awards”, which reflects the capital market’s recognition of the Company’s value, innovation capabilities and growth potential, and is a great encouragement to the Company. In the future, the Company will, in line with its original purposes, endeavor to discover and develop innovative drug targets, explore therapies for immune diseases, accelerate R&D and clinical trials of various products, and at the same time further expand the product pipeline and potential indications, accelerate the realization of product commercialization, strive to bring benefits to patients and create values for shareholders and investors. With the imminent completion of the Phase III clinical trial of its flagship product SM03, the Company is poised for a new leap of increase in value.”
About the Selection of the “7th Hong Kong Golden Stocks Awards”
The selection of the “7th Hong Kong Golden Stocks Awards” was jointly organized by Zhitongcaijing.com, a leading Hong Kong and US stock information platform in China, with RoyalFlush Finance and China Galaxy Securities. This selection was rigorous and attracted over 1,000 entries from Hong Kong-listed companies, covering traditional industries such as petrochemicals, finance, and automobiles, as well as emerging industries such as chips, Internet, and medical and pharmaceuticals, which are leading the transformation of China’s economy.
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), 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.
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