Recently, according to the public information on the NMPA official website, the KL003 cell injection independently developed by Kanglin Biotechnology (Hangzhou) Co., Ltd. successfully obtained the NMPA’s implicit clinical trial license, with the acceptance number CXSL2300699, and is clinically used to treat transfusion-dependent beta in adults or children. -Thalassemia. The microspectrum biosafety service platform provides cell bank testing and strain library testing services for this product. β-thalassemia is a hemolytic anemia caused by defects or mutations in the β-globin gene (Hemoglobin β, HBB) on chromosome 11, resulting in partial or complete loss of β-globin-related functions, which brings great consequences to the patient’s life and health. The patients is more common in children and adolescents. Traditional treatments for thalassemia (blood transfusion, hematopoietic stem cell transplantation, etc.) are accompanied by side effects that cannot be ignored. The vast majority of patients lack the opportunity for radical cure, and there are obvious unmet ...
SHANGHAI, Jan. 07, 2024 /PRNewswire/ — Shanghai Argo Biopharmaceutical Co., Ltd. (“Argo”), a biotechnology company focused on the discovery and development of next-generation RNAi therapeutics, today announced that it has entered into two exclusive license and collaboration agreements with Novartis PHARMA AG (“Novartis”). Under the first agreement, Argo has granted Novartis exclusive global licenses to develop and commercialize a Phase 1 stage program. The first agreement also includes a research collaboration and Novartis also receives an option to potentially license compounds directed against up to two additional targets for cardiovascular disease treatment. Under the second agreement, Argo granted Novartis an exclusive ex-Greater China license to develop and commercialize a Phase 1/2a clinical-stage program for cardiovascular disease treatment. Discovered and developed with Argo’s cutting-edge RNAi platform technology, these clinical-stage assets offer industry-leading efficacy and durability therapies. The transactions have a combined potential value of up to $4.165 billion for Argo and ...
BridGene Biosciences, Inc., a leader in the discovery of small molecule drugs for traditional “hard-to-drug” targets, announced a strategic collaboration and licensing agreement with Galapagos NV. Under the collaboration, BridGene will use its chemoproteomics platform, IMTAC, to discover novel small molecule drug candidates against the collaboration targets. The parties will collaborate to advance the molecules to clinical candidates, which Galapagos has the exclusive rights to develop and commercialize. The preclinical research collaboration will focus on oncology targets named by Galapagos. Galapagos will pay BridGene up to $27 million in upfront and preclinical research milestone payments and more than $700 million in clinical and commercial milestones, assuming success of the programs. BridGene is also eligible to receive tiered royalties on net sales of each product resulting from the collaboration. “BridGene’s proven expertise in discovering small molecule drugs for challenging targets positions them as an ideal partner in pioneering new avenues in ...
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., ...
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