Daily Science and Technology Focus
Microchip Biotech:The product Chidamide Tablets has recently been proposed by the Center for Drug Evaluation of the National Medical Products Administration to be included in the public list of breakthrough treatment varieties.
Dizal Pharmaceutical:At the 2024 ASCO (American Society of Clinical Oncology) Annual Meeting, the company delivered an oral presentation to release, for the first time, the preliminary analysis results of the first international multicenter registrational clinical study "WU-KONG1 Part B, WU-KONG1B" on its self-developed Class I novel lung cancer targeted drug, Sunvozertinib (brand name: Sunvozertinib Tablets). The study focuses on previously treated epidermal growth factor receptor (EGFR) exon 20 insertion mutations (Exon20ins) in non-small cell lung cancer (NSCLC).Biokin:The Phase III clinical trial of the self-developed innovative biologic drug BL-B01D1 (EGFR×HER3-ADC) for monotherapy in patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer who have previously failed anti-PD-1/PD-L1 antibody treatment and platinum-based chemotherapy has recently completed the enrollment of the first participant.Daily Pharmaceutical FocusTellgen:Tellgen's subsidiary Maishi Biotechnology recently received one invention patent certificate issued by the National Intellectual Property Administration of the People's Republic of China. The patent is titled "A Quantitative Analysis Method and Kit for Detecting Multiple Intestinal Microbial Metabolites."Kingfriend:The subsidiary Meitheal Pharmaceuticals, Inc. has recently received the site addition approval letter for Dacarbazine for Injection, 200 mg/vial (ANDA No.: 075259) issued by the U.S. Food and Drug Administration, approving the production at the facility of Jianjin Pharmaceutical Co., Ltd.North China Pharmaceutical Company Ltd.:Xiantai Company, a wholly-owned subsidiary, received the "Approval Notice for Chemical Raw Material Drug Marketing Application" for Ampicillin Sodium issued by the National Medical Products Administration.Menovo:Menovo's wholly-owned subsidiary, Xuancheng Menovo, has successfully passed the technical review of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) for its Dapagliflozin active pharmaceutical ingredient (API). The registration status has been updated to “A” on the CDE’s public platform for API, pharmaceutical excipients, and packaging materials.TIANYU PHARM:The company's Empagliflozin API has recently passed the review of the Center for Drug Evaluation of the National Medical Products Administration.Daily Pharmaceutical News
rhTPO Recommended by "Clinical Diagnosis and Treatment Guidelines for Long-term Systemic Complications of Kidney Transplantation in China" for Treating Thrombocytopenia after Kidney Transplantation
Kidney transplantation is the best choice for treating end-stage renal disease. In the past 20 years, the short-term survival rate of transplant recipients has significantly improved, but the long-term survival rate has not shown obvious enhancement. Long-term systemic complications in transplant recipients severely affect their long-term survival and quality of life, remaining one of the significant concerns in the transplantation field. In view of this, the Organ Transplantation Society of the Chinese Medical Association recently released the "Clinical Diagnosis and Treatment Guidelines for Long-Term Systemic Complications of Kidney Transplantation in China" (hereinafter referred to as the "Guidelines"), which standardizes the diagnosis and treatment of long-term systemic complications in kidney transplant recipients. The Guidelines recommend the use of recombinant human thrombopoietin (rhTPO) for managing thrombocytopenia in kidney transplant recipients, providing strong evidence-based support for the application of rhTPO in the field of organ transplantation.。
Pharmaceutical Valley News | Heartpulse Medical™ Hyperflex® Balloon Dilatation Catheter (Φ32) Approved for Launch in JapanRecently, Shanghai MicroPort CardioFlow MedTech Co., Ltd. (hereinafter referred to as "CardioFlow MedTech™") received registration approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for its Hyperflex® Balloon Dilatation Catheter (Φ32). In March 2022, the Hyperflex® Balloon Dilatation Catheter (Φ40) was first approved for marketing in Japan. The Hyperflex® Balloon Dilatation Catheter is the first domestically developed balloon dilatation catheter in China specifically designed for endovascular aortic repair procedures, assisting in the expansion of aortic stent grafts. The product uses a compliant TPU balloon and is suitable for expanding stent grafts after deployment, allowing the stent graft to unfold more fully and make tighter contact with the vessel wall, thereby eliminating Type I/III endoleaks, enhancing stent graft positioning, and achieving better short-term and long-term therapeutic outcomes.。
Johnson & Johnson Completes Billion-Dollar Acquisition! New Changes in the Cardiovascular MarketOn May 31, Johnson & Johnson announced the completion of its acquisition of Shockwave Medical. Johnson & Johnson acquired all outstanding shares of Shockwave for $335 per share in cash, with the total transaction valued at approximately $13.1 billion. Shockwave will now become part of Johnson & Johnson and operate as a business unit within Johnson & Johnson MedTech. As the world's first company to offer intravascular lithotripsy (IVL) for coronary arteries, Shockwave is committed to providing innovative solutions for treating calcified lesions in coronary artery disease (CAD) and peripheral artery disease (PAD).Currently, the cardiovascular business accounts for less than a quarter of Johnson & Johnson Medical Technologies' overall operations. In the first quarter of this year, the company’s sales reached $7.82 billion. However, through a series of acquisitions, Johnson & Johnson is poised to reestablish its leadership in the cardiovascular field. Notably, in the past two years, the company has made two major acquisitions worth tens of billions of dollars, both targeting the cardiovascular interventional medical device sector. Last month, Johnson & Johnson spent $13.1 billion to acquire Shockwave, a cardiac device company. Two years ago, it also spent $16.6 billion to acquire Abiomed, a company specializing in interventional artificial heart devices. These two significant acquisitions will strengthen Johnson & Johnson’s presence in the cardiovascular interventional device market beyond electrophysiology.Johnson & Johnson CFO Joseph Wolk pointed out that by acquiring Abiomed and Shockwave, Johnson & Johnson is investing in businesses that have already become profit drivers.。
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