On September 6, GlaxoSmithKline (GSK) announced that its Phase 3 MATINEE study of its IL-5 antibody Nucala (mepolizumab) in the treatment of COPD achieved positive results. Compared with the placebo group, the Nucala treatment group achieved a statistically significant reduction in the annualized rate of moderate to severe exacerbations, but specific data have not yet been released. Two months ago, two COPD drugs with new mechanisms: ensifentrine and dupilumab were approved for marketing in the United States and Europe, refreshing the treatment model of this severe respiratory disease. Mepolizumab is expected to join this new round of competition. COPD: The third leading cause of death in humans Chronic obstructive pulmonary disease (COPD), referred to as COPD, is a common, preventable and treatable heterogeneous disease. According to statistics from the World Health Organization, COPD has become the third leading cause of death in humans, with about 11% of people dying from ...
Ascentage Pharma (6855.HK) announced today that the company has published the clinical research results of the company’s original Class 1 new drug Olebatinib (trade name: Nerlik®; research and development code: HQP1351) for the treatment of succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) in the form of a mini oral presentation at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. The clinical data of this oral presentation showed that Olebatinib has sustained clinical efficacy in the treatment of SDH-deficient GIST. As of March 12, 2024, 6 of the 26 patients with SDH-deficient GIST enrolled achieved partial remission (PR), the objective response rate (ORR) was 23.1%, and the median progression-free survival (PFS) was 22 months. In addition, potential mechanism of action (MOA) studies have shown that orebactinib exerts anti-tumor activity by regulating multiple signaling pathways involved in angiogenesis, apoptosis, proliferation and survival. Orebactinib is an original Class 1 new drug ...
On September 3, 2024, the Shenzhen Public Resource Trading Center once again publicly solicited opinions on the “Continuation of Procurement Documents for Centralized Volume Purchase Agreement of Ultrasonic Knife Heads and Pre filled Catheter Flushers (Draft for Comments)”. Enterprises can provide feedback before 17:00 on September 10. The variety of this procurement is ultrasonic blade head (disposable/reusable/integrated handle ultrasonic blade head). After two years, this market is once again experiencing a tense moment. The Guangdong Alliance’s centralized procurement of ultrasonic knives will be launched, and market competition has entered a white hot stage Since the first centralized procurement of ultrasonic cutting heads in Fujian Province in 2020, as of 2024, the centralized procurement areas for ultrasonic cutting heads have spread throughout the country. After this launch, the Guangdong Alliance will become the largest alliance for centralized procurement of ultrasonic knives. At the end of 2021, Guangdong led a 16 province ...
Recently, the National Medical Products Administration announced the approval of Medtronic’s registration applications for two innovative products, the “Heart Pulse Electric Field Ablation Generator” and the “Disposable Heart Pulse Electric Field Ablation Catheter”. Unique advantages, suitable for two indications It is reported that the two innovative products approved this time are Medtronic’s PFA product – PulseSelect, which is the first PFA product approved by NMPA that can be used for both paroxysmal and persistent atrial fibrillation. PulseSelect is a new technique for treating atrial fibrillation (AF) using pulsed electric fields, which can provide bipolar and biphasic pulsed electric fields through a circular multi electrode array catheter. This technology consists of five parts: a controllable multi electrode annular ablation catheter, a PFA host ECG-Gated、 Tableside control、10Fr bidirectional sheath. It is worth mentioning that PulseSelect’s controllable multi electrode annular ablation catheter features a proprietary biphasic waveform, unique built-in guide wire, and a ...
Recently, global orthopedic giant Xerox announced that Mr. Hu Hai, Managing Director of Xerox Greater China, has decided to leave Xerox on September 26th to seek external development opportunities. At present, Hu Hai has not announced where his next destination will be, and Shi Lehui has not yet announced a new successor. Retired veteran resigns In September 2021, Xerox announced the departure of its Managing Director for Greater China, Alaeddin Ahram, and the new Managing Director for Greater China, Hu Hai, took office on September 27th. Hu Hai is a veteran in the field of medical devices, with over 30 years of experience in the field, especially in orthopedics. Prior to joining Xerox, he had extensive work experience in several giant companies, including serving as Vice President of the Joint Division in China at Johnson&Johnson Medical, Vice President of Depuy Synthes in China at Johnson&Johnson Orthopedics, the first CEO and ...
On September 4th, the Shanghai Stock Exchange terminated one IPO company: Shandong Branden Medical Equipment Co., Ltd. (hereinafter referred to as “Branden”). According to information, this was Branden’s voluntary withdrawal of its listing application, and the listing on the Science and Technology Innovation Board was terminated. Two major products support the banner of revenue Founded in 2003, Baibai An is a national high-tech enterprise dedicated to applying medical material modification technology to implantable medical devices, focusing on the research and development, production, and sales of biological and medical products. Through independent research and continuous innovation, Branden has formed a technology platform centered on medical material modification, precision machining, and digital diagnosis and treatment of vascular pathways. According to the prospectus, Branden is the first domestic enterprise to obtain the registration certificate for Class III medical device products of domestically produced Peripherally Inserted Central Catheters (PICCs), breaking the monopoly of imported ...
Recently, Beijing Pinchi Medical Equipment Co., Ltd. (hereinafter referred to as “Pinchi Medical”) completed the listing guidance registration and planned IPO at the Beijing Securities Regulatory Bureau, and the guidance institution is CICC. According to the counseling work arrangement, CICC plans to complete the counseling plan for Pinchi Medical in November and December this year, and apply to the Beijing Securities Regulatory Bureau for counseling acceptance. After the counseling is completed and accepted, Pinchi Medical may apply for an IPO. This is another brain pacemaker company that plans to go public through an IPO in 2023 after Jingyu Medical started filing for listing counseling. According to Smart Medical Equipment, so far, the only two local companies that mass-produce brain pacemakers have embarked on the road to IPO. Founded in 2008, Pinchi Medical is a high-tech enterprise specializing in the research and development, production and sales of a series of neuromodulatory ...
Today (September 5th), the China National Medical Products Administration’s Center for Drug Evaluation (CDE) announced on its official website that Novo Nordisk’s application for the new drug market launch of Paxin Injection has been accepted. According to public information, this should be the weekly long-acting growth hormone Sogroya developed by Novo Nordisk ® (Somapacitan). The Phase 3 study of this product in China for the treatment of children with slow growth caused by insufficient secretion of growth hormone has been completed. Sogroya ® (somapactan) injection is a human growth hormone analog containing growth hormone similar to that produced by the human body, which can be used to treat adult growth hormone deficiency (AGHD). Sogroya ® has been approved in the United States, European Union, Japan, Australia, and Saudi Arabia for subcutaneous injection once a week as a replacement therapy for endogenous growth hormone in adult growth hormone deficiency (AGHD) patients. ...
Recently, Beijing Pinchi Medical Equipment Co., Ltd. (hereinafter referred to as “Pinchi Medical”) completed its IPO counseling and registration with the Beijing Securities Regulatory Bureau, with the counseling agency being China International Capital Corporation (CICC). According to the coaching work arrangement, CICC plans to complete the coaching plan for Pinchi Medical in November December this year and apply for coaching acceptance from the Beijing Securities Regulatory Bureau. After completing the coaching acceptance, Pinchi Medical may apply for IPO. This is another brain pacemaker company planning to go public in 2023, following Jingyu Medical’s IPO guidance filing. According to reports from Smart Medical Devices, the only two local companies that mass produce brain pacemakers have now embarked on the path of IPO and planned to go public. Tsinghua endorsement, Pinchi Medical is aiming for IPO Pinchi Medical was founded in 2008 and is a high-tech enterprise specializing in the research, development, ...
Recently, the drug marketing authorization application for the JAK1 inhibitor amaxitinib sulfate tablets (SHR0302 tablets) was accepted by the State Food and Drug Administration. This product is suitable for adult patients with severe alopecia areata. At present, no JAK1 inhibitor self-developed by domestic companies has been approved for marketing. In addition to the indications for alopecia areata, the marketing authorization application for Amaxitinib Sulfate Tablets has been accepted by the State Food and Drug Administration for three indications, namely: moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above, and ankylosing spine. inflammation and moderate to severe active rheumatoid arthritis. In June 2024, the main research endpoint of the Phase III clinical trial of Emmaxitinib Sulfate Tablets reached the superiority standard preset in the protocol. This study is a randomized, double-blind, and placebo-controlled Phase III study to evaluate the effectiveness and safety of amaxitinib sulfate tablets ...
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