SM03

SinoMab Awarded the "Most Valuable Pharmaceutical and Medical Company" in the Selection of the "7th Hong Kong Golden Stocks Awards"

Retrieved on: 
Monday, December 19, 2022
Clinical trial, The Company, Neuromyelitis optica spectrum disorder, Multiple sclerosis, FV, Antigen, B-cell lymphoma, The Group, State, National Medical Products Administration, Sjögren syndrome, Research, Rheumatoid arthritis, MS, Penumbra (medical company), SM03, Barakat Pharmaceutical Group, Death, Republic, NHL, NMPA, Alzheimer's disease, NDA, Mab, R, FIH, Sino Biopharmaceutical Limited, Patient, Attention, Degenerative disease, RA, NMOSD, Safety, BCR, Therapy, State Council, IND, SLE, Pemphigus, Immune system, Phase, AD, Central China, CD22, Pharmaceutical industry, Vaccine

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.

Key Points: 
  • 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.
  • Currently, various candidate products for all-field indications of autoimmune diseases in SinoMab's layout have started clinical trials successively and are progressing steadily.
  • Previously, SinoMab appointed Mr. Shanchun WANG as the President (China) of the Company, mainly responsible for the China operation.

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

Retrieved on: 
Friday, November 4, 2022
Technology, Company, SM03, Pemphigus, Research, Central China, Therapy, Growth, Asthma, The Company, Non-Hodgkin lymphoma, State Council, NHL, Damage-associated molecular pattern, Lupus, Twelfth, Sino Biopharmaceutical Limited, SLE, Barakat Pharmaceutical Group, RA, Rheumatoid arthritis, The Group, Thirteenth, WANG, CD22, Autoimmune disease, B-cell lymphoma, Mab, Degenerative disease, Pharmaceutical industry, Group

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.

Key Points: 
  • 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.
  • Dr. Shui On LEUNG said that: "It is a great pleasure to have Mr. Shanchun WANG joining the Company.
  • 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.

Sinomab Announces IND Application of SN1011 for the Treatment of Neuromyelitis Optica Spectrum Disorder Approved by NMPA

Retrieved on: 
Wednesday, August 24, 2022
Ibrutinib, Investigational New Drug, The Company, Rheumatoid arthritis, Safety, CD22, Research, RA, Central nervous system, Degenerative disease, IND, Smoking, SLE, Mab, Disease, EBV, Multiple sclerosis, Epstein–Barr virus infection, R, National Medical Products Administration, Thirteenth, Asthma, B-cell lymphoma, Twelfth, NHL, NMPA, Antibody, Non-Hodgkin lymphoma, Neuromyelitis optica spectrum disorder, Company, Therapy, Lupus, PV, NMOSD, The Group, MS, Optic nerve, Optic neuritis, Spinal cord, Drug discovery, SM03, BTK, Trial of the century, Pemphigus, Pharmaceutical industry, Phase

The IND approval would enable the Company to initiate the Phase II/III clinical study in China to evaluate the efficacy and safety of SN1011 for the treatment of NMOSD in China.

Key Points: 
  • The IND approval would enable the Company to initiate the Phase II/III clinical study in China to evaluate the efficacy and safety of SN1011 for the treatment of NMOSD in China.
  • SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety.
  • Currently, four IND applications of SN1011 for the treatment of SLE, PV, MS and NMOSD have been approved by NMPA respectively.
  • SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases.

SinoMab Received the Highest Subsidy from HKSTP

Retrieved on: 
Friday, July 8, 2022
Patient, Heart, Research, Pemphigus vulgaris, NMOSD, Investigational New Drug, Hong Kong Science and Technology Parks Corporation, Growth, Company, Industry, Innovation and Technology Bureau, Mab, IND, Neuromyelitis optica spectrum disorder, National Medical Products Administration, Thirteenth, Twelfth, PV, Therapy, Science park, NMPA, CD22, The Company, RA, B-cell lymphoma, MS, Biotechnology, Electronics, Technology, SLE, ITR, Lupus, Multiple sclerosis, Ecosystem, I&T, Translational research, GBA, CTC, Center for Drug Evaluation and Research, Rheumatoid arthritis, CDE, Trial of the century, SM03, HKSAR, R, BTK, The Group, NHL, Safety, Asthma, HKSTP, Center, Program, Hong Kong Science Park, Pharmaceutical industry, Guangdong-Hong Kong-Macau Greater Bay Area

Under this program, funding support will be provided to biomedical companies of HKSTP to bring innovative, life-changing therapies and technologies to patients.

Key Points: 
  • 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.
  • 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.
  • 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.

SinoMab Dosed First Healthy Subject in Phase I Clinical Trial of SM17 in the U.S.

Retrieved on: 
Wednesday, June 15, 2022
Organic, Industry, T helper cell, FDA, Food and Drug Administration, Therapy, Health, FIC, Safety, State, The Company, NHL, RA, CD22, SM03, Pemphigus vulgaris, Company, Coronavirus Scientific Advisory Board (Turkey), Asthma, Pharmacokinetics, Innate lymphoid cell, Research, B-cell lymphoma, Disease, Investigational New Drug, Rheumatoid arthritis, Mab, FRS, Molecular biology, MRC Laboratory of Molecular Biology, IND, Quality of life, SAD, Lupus, LifeArc, Single, Thirteenth, SLE, Food, Patient, Francis Crick Institute, United Kingdom, PV, MAD, Twelfth, LMB, The Group, Risk, Pharmaceutical industry, ILC2

SM17 is currently under development by SinoMab, and was engineered by LifeArc (a leading medical research charity based in the United Kingdom).

Key Points: 
  • SM17 is currently under development by SinoMab, and was engineered by LifeArc (a leading medical research charity based in the United Kingdom).
  • Despite the pandemic, SinoMab have soon initiated the first-in-human dose in the Phase I clinical trial.
  • After evaluating and choosing the lead candidate, it was licensed to SinoMab to take forward into clinical development and towards patients.
  • Following our flagship product, SM03 and key product, SN1011, we now have another key asset entering the clinical trial stage.

SinoMab Announces IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE

Retrieved on: 
Thursday, June 9, 2022
The Company, National Medical Products Administration, Degenerative disease, CDE, Company, Neuromyelitis optica spectrum disorder, Pemphigus vulgaris, Lupus, Research, NHL, Mab, Drug discovery, Safety, CD22, Epstein–Barr virus infection, SM03, RA, SLE, Central nervous system, Optic neuritis, Disease, Smoking, Center, Investigational New Drug, IND, Therapy, Optic nerve, NMPA, Spinal cord, Twelfth, PV, Thirteenth, Patient, MS, BTK, Rheumatoid arthritis, Incidence, Antibody, Union, IL-6, Multiple sclerosis, US, The Group, Center for Drug Evaluation and Research, EBV, Asthma, NMOSD, B-cell lymphoma, Recurrence, Pharmaceutical industry, Pemphigus, Phase

The Company plans to initiate the Phase II clinical study in China upon approval of the present IND.

Key Points: 
  • 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 differentiates from existing BTK inhibitors currently available in the market in terms of mechanism of action, affinity, selectivity and safety.
  • 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.

SinoMab Announces IND APPLICATION FOR SN1011 APPROVED BY NMPA

Retrieved on: 
Wednesday, April 20, 2022
Pemphigus vulgaris, BTK, SM03, Investigational New Drug, Twelfth, IND, Multiple sclerosis, RA, Spinal cord, CD22, B-cell lymphoma, Asthma, NMPA, Ibrutinib, Research, NHL, The Group, Lupus, Pemphigus, Brain, CAGR, Patient, MS Research Australia, Demyelinating disease, The Company, Rheumatoid arthritis, Company, US, Degenerative disease, Movement disorders, SLE, Safety, Mab, National Medical Products Administration, Prevalence, MS, Thirteenth, Therapy, PV, Drug discovery, Pharmaceutical industry, Phase

The IND approval would enable the Company to initiate the Phase II clinical study to evaluate the efficacy and safety of SN1011 in patients with multiple sclerosis in China.

Key Points: 
  • The IND approval would enable the Company to initiate the Phase II clinical study to evaluate the efficacy and safety of SN1011 in patients with multiple sclerosis in China.
  • SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety.
  • 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 for pemphigus in the third quarter of 2022.
  • The approval of this IND application is the third indication of SN1011 in China following the approval of IND application for SLE and pemphigus, fully demonstrating the great potential of our innovative BTK inhibitor in the field of the treatment of autoimmune diseases.

IND Application for SinoMab's First-in-Class Asthma Therapeutic Product SM17 Approved by FDA

Retrieved on: 
Monday, March 14, 2022
Safety, United Kingdom, Asthma, FIH, Patient, Risk, Rheumatoid arthritis, Company, IND, Research, Lupus, Therapy, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, LifeArc, Allergy, Quality of life, Pemphigus vulgaris, Idiopathic pulmonary fibrosis, Investigational New Drug, The Company, Mab, Humanized antibody, Twelfth, CD22, RA, Lincoln Hospital (Bronx), T helper cell, NHL, Thirteenth, FIC, B-cell lymphoma, The Group, PV, Food, SLE, SM03, Health, Pharmaceutical industry, PRC

The IND approval would enable the Company to initiate the First-In-Human (FIH) study in the U.S. in the first quarter of 2022 at the earliest.

Key Points: 
  • The IND approval would enable the Company to initiate the First-In-Human (FIH) study in the U.S. in the first quarter of 2022 at the earliest.
  • Patients with severe, uncontrolled asthma are at a risk of recurrent asthma exacerbations and hospitalizations, and uncontrolled severe asthma is associated with increased mortality/morbidity, diminished quality of life and increased health expenditures.
  • Current approved therapies for severe asthma, including biologics, can reduce asthma annual exacerbation rates to a certain extent.
  • The Company believes the huge potential of SM17 to satisfy unmet medical needs in asthma treatment.

IND Application for SinoMab's First-in-Class Asthma Therapeutic Product SM17 Accepted by FDA

Retrieved on: 
Thursday, February 17, 2022
United Kingdom, Asthma, Twelfth, Patient, Food, Mortality, The Group, Company, The Company, Allergy, PV, NHL, Idiopathic pulmonary fibrosis, LifeArc, Mab, IND, NMPA, Safety, T helper cell, Drug resistance, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Therapy, Rheumatoid arthritis, Cytokine, FIC, Humanized antibody, SLE, Drug discovery, US, SM03, CD22, Investigational New Drug, RA, FDA, Pemphigus vulgaris, R gene, Research, Thirteenth, Lupus, B-cell lymphoma, Drug development, EST, Sclerosis, Pharmaceutical industry, PRC

The Company plans to initiate the First-In-Human study in the U.S. in first quarter of 2022, once IND is approved by FDA.

Key Points: 
  • The Company plans to initiate the First-In-Human study in the U.S. in first quarter of 2022, once IND is approved by FDA.
  • SM17 is the world's first monoclonal antibodies targeting IL17BR co-developed by SinoMab and LifeArc (a medical research charity based in the United Kingdom).
  • SM17 has a wide range of indications, including indications with large market volumes such as asthma and diseases with high mortality rates such as idiopathic pulmonary fibrosis.
  • With the preclinical data and unique mechanism of action of SM17, Company believes that SM17 potentially has a broader and more beneficial effect on asthma treatment than other approved biologics.

SinoMab Announces IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE

Retrieved on: 
Monday, February 7, 2022
SLE, Drug discovery, Lupus, RA, Product life-cycle theory, Research, Multiple sclerosis, Company, Thirteenth, Ibrutinib, Asthma, IND, Rheumatoid arthritis, B-cell lymphoma, Program, NHL, CD22, BTK, Patient, Investigational New Drug, Safety, National Medical Products Administration, CDE, Mab, Center, Therapy, SM03, The Group, Pemphigus vulgaris, PV, NMPA, Twelfth, Center for Drug Evaluation and Research, The Company, Pharmaceutical industry, Phase

The Company plans to initiate the Phase II clinical study in China upon approval of the present IND.

Key Points: 
  • 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 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety.
  • SinoMab BioScience Limited (stock code: 3681.HK) is dedicated to the research, development, manufacturing and commercialization of therapeutics for the treatment of immunological diseases.