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Tag: arthritis

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Kindstar Globalgene Announces FY2021 Annual Results, Revenue Increases to RMB930.67 Million

HONG KONG, Mar 25, 2022 - (ACN Newswire) - Kindstar Globalgene Technology, Inc. ("Kindstar Globalgene" or the "Company", together with its subsidiaries, collectively the "Group"; stock code: 9960.HK), a leading independent esoteric clinical testing service provider in China, today announced its audited annual results for the year ended 31 December 2021 ("2021" or the "Year").

During the period under review, the Group recorded total revenue of RMB930.67 million, representing a year-on-year increase of 4.4%. Revenue from non-COVID-19-related testing services was RMB868.57 million, an increase of 12.3%. The Group's consolidated gross profit was up by 5.4% year-on-year to RMB485.77 million, while the consolidated gross profit margin rose by 0.5% year-on-year to 52.2%. Cash and cash equivalents amounted to RMB1,796.7 million, a growth of 113.6% year-on-year. The non-COVID-19-related testing services segment recorded results of RMB197.18 million, an increase of 17.5% year-on-year. The Board has resolved not to distribute a dividend for FY2021.

Focused on specialty esoteric testing services and vigorously developed related services in six major specialty areas

Since its inception in 2003, the Group has been focusing on esoteric clinical testing services and is one of the first companies in China entering the esoteric testing service industry. During the period under review, the Group covered more than 3000 hospitals, in which over 60% are Class III hospitals, added three new laboratories and its esoteric testing volume exceeded 1.68 million, with positive growth in all six major esoteric testing specialty areas.

-- Hematology testing: The Group introduced 50 new testing items and added the Shanghai Xinnuo Baishi Medical Laboratory. During the period, the Group achieved revenue of RMB535.27 million and segment results of RMB152.57 million, representing a year-on-year increase of 14% and 15.7%, respectively.
-- Neurology testing: The Group launched six new projects covering diseases such as Alzheimer's disease and myasthenia [gravis] and also added 143 partnering Class III hospitals. The Group recorded revenue of RMB89.85 million and segment results of RMB14.06 million during the period, a year-on-year increase of 18.2 and 11.6%, respectively.
-- Maternity-related testing: The Group added the diagnosis of gestational syndromes during the period, and recorded revenue of RMB52.25 million and segment results of RMB3.55 million, representing a year-on-year increase of 0.2% and 0.5%, respectively.
-- Genetic disease and rare disease testing: During the period, the Group realized revenue of RMB43.50 million and segment results of RMB5.43 million, representing a year-on-year increase of 20.2% and 126.4%, respectively. Sales of multiple steroid hormone tests doubled year-on-year.
-- Infectious disease testing: The Group introduced 28 new testing items and added the Wuhan Kindstar Zhenyuan Medical Laboratory, achieving revenue of RMB51.97 million and segment results of [RMB]9.78 million during the period, representing a year-on-year increase of 3% and 33.2%, respectively.
-- Oncology testing: The Group launched new testing service items for various types of cancer, including intestinal cancer, cervical cancer, bladder cancer and liver cancer, achieving revenue of RMB8.62 million and segment results of RMB0.83 million during the period, 13.4% and 82.5% higher than the same period last year.
-- Others: The Group added more than 20 scientific research service projects in the areas of research services, CRO and new testing services, achieving revenue of RMB19.46 million and segment results of RMB5.99 million during the period, representing a year-on-year growth of 36.1% and 35.1%, respectively.

Persistent R&D investment to develop and expand new specialty esoteric testing business lines

As at 31 December 2021, the Group's R&D expenses amounted to RMB90.33 million, a year-on-year increase of 20.0%.The Group had 112 new R&D projects, 17 patents were pending or granted and 23 scientific research articles were published throughout the year. During the period under review, the Group stepped up its efforts in promoting the development of specialty esoteric testing services in China and expanding the scope of such services to cover cardiovascular diseases, ophthalmology, rheumatology and immunology.

-- Cardiovascular diseases: The Group focused on the R&D of biomarkers for cardiovascular diseases such as coronary heart disease, acute myocarditis and acute myocardial infarction. It also conducted verification studies on the clinical value of biomarkers.
-- Ophthalmology: The Group actively explored opportunities in ophthalmic structured esoteric testing services and its R&D covered testing solutions for hereditary oculopathy, infectious oculopathy and autoimmune oculopathy.
-- Rheumatology and immunology: The Group began the initial development of six types of disease and drug detection projects, covering sicca syndrome, rheumatoid arthritis, ankylosing spondylitis, gout, antiphospholipid syndrome and allopurinol detection.

Entered the IVD reagents field and optimized immune repertoire deployment

Wuhan Haixi Life Science Technology Co., Ltd., which the group owns a controlling stake, is a high-tech enterprise based on the R&D, manufacturing and sales of esoteric testing reagents providing systematic, comprehensive "high-precision and cutting edge" testing reagent products. The Group's main products, namely reagent kits for JAK2 genes and V617F mutations (PCR-fluorescent probe method) and reagent kits for leukemia fusion genes qualitative testing (PCR-fluorescent probe method) will enter the clinical trial stage of NMPA registration. During the period under review, the Group established its business presence in the field of IVD reagent kits in the upstream industry chain by holding shares in Wuhan Haixi Life Science Technology Co., Ltd.

As an important next-generation sequencing technology, the immune repertoire sequencing technology may bring disruptive changes to the industry in the future. During the period under review, the Group established Wuhan Kindstar Biotechnology Co., Ltd., which will focus on the application and development of the immune repertoire technology in multiple disciplines and explore the biopharmaceutical and immunotherapy pathways. In addition, to further improve its immune repertoire layout, the Group invested in Shenzhen Neoimmune Co., Ltd., a leading immune repertoire enterprise in China. Looking ahead, the two parties will commence strategic cooperation in the immune repertoire segment.

Strategy and Prospects

The Group will continue to consolidate its leading position in esoteric hematology testing in China and replicate its successful experience in hematology to expedite the growth of its specialty esoteric testing business in areas such as genetic diseases, rare diseases, infectious diseases, oncology and neurology. In the next three to five years, the Group will enter several new areas of specialty esoteric testing. At the same time, the Group is also committed to building strong relationships with a wide range of participants in the clinical esoteric testing industry (including doctors, hospitals, pharmaceutical companies, contract research institutions, academic institutions and regulatory agencies), deepening existing strategic partnerships, and expanding the existing cooperation network. Since its listing, the Group has attached great importance to opportunities for horizontal and vertical integration in the industrial chain. In the future, the Group will steadily achieve a strategic and forward-looking layout through investment, integration and empowerment, in order to boost its growth.

Huang Shiang, Chairman and Chief Executive Officer of Kindstar Globalgene, expressed full confidence in the future of China's esoteric clinical testing industry. He said, "Due to increasing public health awareness and an aging population in China, the demand for clinical tests has continued to increase. In recent years, China's esoteric clinical testing market has been growing faster than its routine testing market, and the Company has strived to develop and introduce advanced technologies to meet the enormous unmet medical demand in the country. Looking ahead, we will actively overcome the various uncertainties caused by the COVID-19 pandemic, while continuing to work hard to maintain the steady growth of our existing esoteric clinical tests, and develop and launch new services in specialty areas, thereby contributing to the precise diagnosis and advancement of treatments in specialty areas in China."

Kindstar Globalgene 2021 Annual Results Announcement:
https://www1.hkexnews.hk/listedco/listconews/sehk/2022/0325/2022032501238.pdf

Infographics for Kindstar Globalgene 2021 Annual Results Announcement:
https://mp.weixin.qq.com/s/h1rKtS_79dJ-Symd7Prz0w

About Kindstar Globalgene Technology, Inc.
Kindstar Globalgene Technology, Inc. ("Kindstar Globalgene" or the "Group"; stock code: 9960.HK) is a leading independent esoteric clinical testing service provider and a major provider of hematology esoteric testing services in China. It has built a comprehensive testing portfolio, a broad hospital network and advanced technology platforms and also boasts the largest esoteric testing portfolio among all independent esoteric testing providers in China, with more than 3,500 tests on its service menu and offering one of the most extensive hematology testing portfolios worldwide, including over 2,300 testing items in the field. The Group primarily targets specialty areas with substantial growth potential or that can create significant synergies with its esoteric hematology testing services, including genetic diseases and rare diseases, infectious diseases, oncology and neurology. The Group was listed on the Main Board of the Hong Kong Stock Exchange on 16 July 2021. Over the past 18 years, the Company has developed more than 1,100 testing items entirely in-house, and introduced approximately 2,400 testing items developed by or under license from third parties. The Group serves more than 3,000 hospitals in China, of which more than 1,500 are Class III hospitals, including all of the top 20 hospitals in the nation. The Group's mission is to offer a broad range of high-quality specialty testing services to patients and physicians worldwide, and to promote the application of precision diagnostics and medicine.

The Group's website: https://www.kindstar.com.cn/tc/



Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comKindstar Globalgene Technology, Inc. ("Kindstar Globalgene" or the "Company", together with its subsidiaries, collectively the "Group"; stock code: 9960.HK), a leading independent esoteric clinical testing service provider in China, today announced its audited annual results for the year ended 31 December 2021 ("2021" or the "Year").

Rheumatoid Arthritis (RA) Therapy Area Report, 2022 ā€“ Uncover Key Unmet Needs of Patients, Hot Topics of Conversation Amongst Physicians, and Assess Pharma Company...

DUBLIN–(BUSINESS WIRE)–The “Rheumatoid Arthritis (RA) Therapy Area Report” report has been added to ResearchAndMarkets.com’s offering. This latest report offers fresh insights into the Rheumatoid Arthritis (RA) online space, from the perspective of multiple stakeholders, as well as evaluating key companies’ social media activity. The report, which is based on both machine and human-led analysis, uncovers […]

The post Rheumatoid Arthritis (RA) Therapy Area Report, 2022 – Uncover Key Unmet Needs of Patients, Hot Topics of Conversation Amongst Physicians, and Assess Pharma Company Online Activity – ResearchAndMarkets.com appeared first on Fintech News.

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

HONG KONG, Feb 17, 2022 - (ACN Newswire) - 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 11 February 2022 (EST local time), an Investigational New Drug application ("IND"), for the Company's First-in-Class (FIC) asthma therapeutic product SM17 (Humanized anti-IL17RB monoclonal antibody for injection) has been submitted and accepted by the U.S. Food and Drug Administration ("FDA"). 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's mechanism of action

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. Comparing to other products on the market, SM17 enjoys differentiation advantages. 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.

In the global market, the number of asthma patients is gradually increasing and is expected to reach 247.5 million by 2023 and further increase to 267.7 million by 2030. The number of asthma patients in the PRC is increasing at a greater pace than the global rate and is forecasted to reach 25.6 million by 2023 and further increase to 27.8 million by 2030. In terms of market size, the global asthma market is projected to reach US$25.1 billion by 2023 and US$34.6 billion by 2030. However, the asthma market in the PRC is expected to reach RMB36.4 billion by 2023 and RMB65.0 billion by 2030. In terms of treatment options, traditional asthma treatment is based on inhaled corticosteroid, but they are prone to serious adverse effects, especially in adolescents. Drug resistance can also develop if used for a long time. The introduction of SM17 is expected to provide a better treatment option in terms of the balance of efficacy and safety.

Dr. Shui On LEUNG, Chairman, Executive Director and Chief Executive Officer of SinoMab said that: "following the acceptance of the IND application for SN1011 for the treatment of multiple sclerosis by the NMPA, the acceptance of the SM17 IND application by the FDA fully demonstrates the efficient execution of the Company's new drug R&D program. There is still an unmet medical need for additional effective therapies, particularly for patients who do not respond to current treatments. We are therefore confident in the enormous prospects of SM17's clinical development. Our core products, including SM03, SN1011 and SM17, is making progress on the clinical R&D smoothly, driving the Company moving steadily towards commercialization. In the future, we will accelerate our projects implementation to bring benefits to patients and create value for shareholders through innovation."

About SM17
SM17 is known to be the world's first humanized, IgG4-k monoclonal antibody for new drug development, which targets IL-17RB. And IL-17RB is a type-I single transmembrane glycoprotein belonging to IL-17 receptor family. The binding of SM17 to IL-17RB could suppress Th2 immune responses induced by a category of cytokines called "alarmin", which has shown to be implicated in the pathogenesis of allergic disease and airway viral responses. Alternative approach targeting upstream mediators of the Th2 inflammatory cascade, such as "alarmins", is expected to have a broader effect on airway inflammation and to provide more effective asthma control than currently available therapies, and products with similar mechanism of action as SM17 have been approved by FDA.

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.


Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comSinoMab 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

SinoMab Announces IND APPLICATION FOR SN1011 ACCEPTED BY NMPA CDE

HONG KONG, Feb 7, 2022 - (ACN Newswire) - 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.



Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comSinoMab 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,

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