Recently, MBS314, an innovative tri-specific antibody product developed by Beijing Mabworks Biotech Company Limited (hereinafter referred to as “Mabworks”) in collaboration with Kangyuan Botron Biotechnology (Beijing) Limited, has obtained the Notice of Approval for Clinical Trial of Drugs issued by the State Drug Administration of the People’s Republic of China (SDA), which authorizes the conduct of Phase I/II clinical trial for the treatment of multiple myeloma. Myeloma. MBS314 is a new mechanism of tri-specific antibody targeting CD3/BCMA/GPRC5D for the treatment of multiple myeloma.MBS314 has a differentiated CD3 binding epitope, which is able to achieve low-affinity but long-lasting activation and killing effect with T-cells, with better safety; at the same time, it binds BCMA and GPRC5D with high affinity, which is able to overcome BCMA and GPRC5D tumor cell killing effect in the body of the patient. At the same time, the high affinity combination of BCMA and GPRC5D can overcome ...
While it may appear that hospital administrators and biotech CEOs have quite dissimilar jobs because they face different challenges daily, this article attempts to conveys the value of some of the underlying principles that one can develop in the field of hospital administration, that may have some value in other healthcare fields and in other executive positions. By PETE O’HEERON When one thinks of the dynamic biotech landscape, with many early-stage firms delving into therapies for diverse maladies, such as cancer or heart disease, to any of a number of rare diseases, the executive leadership image that arises is certainly quite different than one might imagine for a healthcare executive, such as a hospital administrator. While patient health might be an end goal for both, the milieu within which they operate is seemingly quite distinct. It is certainly not typical for individuals to transition between these two realms, and yet, ...
On Oct 17, RemeGen Co., Ltd. (688331.SH/09995.HK) announced that the global multicenter Phase III clinical IND of Telitacicept for the treatment of adults with active primary Sjögren’s syndrome has been approved by the U.S. FDA. Clinical studies will be carried out in many countries and regions around the world. This is a multicenter, randomized, double-blind, placebo-controlled phase III trial to evaluate the efficacy and safety of Telitacicept in the treatment of adults with active primary Sjögren’s syndrome (pSS), and the evaluation of pharmacokinetic characteristics, pharmacodynamics and immunogenicity will also be conducted. In a series of previous non-clinical projects and clinical trials, the efficacy and safety of Telitacicept in adult patients with pSS have been confirmed. In a phase II study (18C012) involving 42 adult pSS patients in China, both the 240 mg and 160 mg dosage regimens of Telitacicept for Injection showed good efficacy and tolerability. This 48-week global phase ...
Nanjing, China– InxMed, a clinical-stage biotechnology company dedicates on developing innovative therapies against drug resistance, and Escugen, a clinical-stage antibody–drug conjugate (ADC) company, today announced that InxMed licensed EZWi-Fit® linker-payload platform from Escugen for the development of the next generation tumor-associated antigens (TAAs) targeting ADCs. The license agreement provides InxMed with right to use EZWi-Fit® platform on the several novel ADC candidate molecules. InxMed will have the right for development, manufacturing, and commercialization of these ADC candidate molecules. InxMed is developing next generation TAAs targeting ADCs with significant improvement of efficacy and therapeutic window. Meanwhile, the company is developing solutions to boost ADC’s efficacy including enhancing ADC penetration via FAK inhibitor and developing stroma targeting ADC to create synergy. InxMed is positioned to invent next generation ADCs, with the attributes to be more tumor selective and potent, and broad combination potential. The novel antibodies discovered by InxMed to be equipped ...
Harbour BioMed’s Wholly-owned Subsidiary, Nona Biosciences, announced today that it has entered into an exclusive license agreement with Pfizer Inc. for the global clinical development and commercialization of Nona Biosciences’ MSLN-targeted antibody-drug conjugate (ADC), HBM9033. Under the terms of the agreement, Nona Biosciences will receive a total of up to $53 million in upfront and near-term payments, with the potential for additional payments of up to $1.05 billion upon achieving certain development and commercial milestones. Nona Biosciences is also eligible to receive tiered royalties on net sales ranging from high single digits to high teens. “We are delighted to collaborate with Pfizer, a company that is committed to developing high-impact medicines for people living with cancer,” said Jingsong Wang, M.D., Ph.D., Chairman of Nona Biosciences. “This agreement represents a significant milestone in the advancement of our proprietary Harbour Mice® platform and the ADC ecosystem, affirming Nona’s robust capabilities and expertise ...
Beijing, China, Cambridge, Massachusetts, USA, and Basel, Switzerland—BeiGene (Nasdaq: BGNE; Hong Kong Stock Exchange: 06160; Shanghai Stock Exchange: 688235), a global biotechnology company, today announced that it has The commercialized products and new indications have been successfully entered into the “National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2023)” (“National Medical Insurance Drug Catalog”) issued by the National Medical Insurance Administration (“National Medical Insurance Administration”). Among them, the company’s independently developed anti-PD-1 antibody Zelzian® (tislelizumab injection) and BTK inhibitor Baiyezan® (zanubrutinib capsules) successfully renewed their contracts and added two new adaptations respectively. The disease was included in the national medical insurance drug catalog; the cooperative products introduced the long-acting goserelin microsphere preparation Bituowei® (goserelin microspheres for injection), the rare disease Castleman’s disease treatment drug Savinco® (stuximab for injection) ) was included for the first time, while the RANKL inhibitor Anjiavir® (desomasumab injection, 120 mg (1.7ml)/bottle) was ...
Walvax Biotechnology Co., Ltd. (hereinafter referred to as the “Company”), in cooperation with Fudan University and Shanghai Blue Magpie Biopharmaceutical Co. (hereinafter referred to as the “RQ3033 Vaccine” or the “Vaccine”) developed by the Company in cooperation with Fudan University and Shanghai Blue Magpie Bio-pharmaceutical Company Limited (hereinafter referred to as the “Shanghai Blue Magpie”), which was approved by the relevant state departments for inclusion in the Emergency Use Program after receiving a letter from the Vaccine Research and Development Task Force of the State Council’s Research and Development Group of the Joint Prevention and Joint Control Mechanism on December 1, 2023 The “Vaccine” was approved for emergency use by the relevant state departments. The RQ3033 vaccine is an iterative vaccine developed on the basis of the mRNA technology platform jointly established by the Company, Fudan University and Shanghai Blue Magpie, and on the basis of the first-generation vaccine, i.e., ...
IGM Biosciences plans to axe 22% of its workforce, becoming the latest company to downsize in a bid to free cash resources. Amid the layoffs, the US-based biotechnology company will also reprioritise its pipeline, discontinuing operations for all haematologic oncology and targeted cytokine product development while doubling down on its efforts in the clinical development of T cell engagers for autoimmune diseases and a DR5 agonist for colorectal cancer. IGM expects the restructuring to extend the company’s cash runway into Q2 2026. The restructuring comes less than a month after the company said it anticipated an increase in headcount to support the research and development of its pipeline candidates, citing its intent to advance and expand its antibody product pipeline, in its 13 November 10-Q filing. In the same filing, the company acknowledged that it had significant net losses to date and that achieving profitability sufficient enough to offset the ...
The University of Edinburgh, the University of Arts London, Silchar Medical College, Assam University and the Indian Institute of Technology Delhi have collaborated on a new UK-India research project, DOSA2, to help combat antimicrobial resistance (AMR). LifeArc, UK Research and Innovation, Economic Social Science Research Council, the Newton fund and the government of India’s Department of Biotechnology will fund and support the Diagnostics for One Health and User Driven Solutions for Antimicrobial Resistance (DOSA) project. Designated as one of the top ten global public health threats facing humanity by the World Health Organization, AMR occurs when bacteria, fungi and parasites change and adapt to antibiotics over time. Globally, urinary tract infections (UTIs) are the second leading cause of antibiotic consumption, often purchased over the counter in India, one of the highest human antibiotic-using countries in the world, and taken without medical supervision, contributing to the global issue of AMR. The ...
Cancer Research UK (CRUK), its innovation unit, Cancer Research Horizons, and Guardant Health have announced a collaboration to advance the development and precision of cancer detection and treatment. The mission-focused collaboration aims to accelerate the discovery and development of cancer drugs and diagnostics for patients. Affecting 20% of people in the UK, rare cancers are forms of cancer that can occur in unusual places in the body, requiring special treatment. Challenging to treat, rare cancer types include melanoma skin cancer, kidney cancer, brain tumours, non-Hodgkin lymphoma and pancreatic cancer. As part of the agreement, the parties will be able to discuss opportunities for collaboration to support CRUK’s research and development activities. In particular, the agreement will focus primarily on the charity’s clinical trials run by its Centre for Drug Development (CDD), including the DETERMINE trial, as well as other CRUK and Cancer Research Horizon research collaborations. The DETERMINE trial is ...
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