On the evening of December 16, Kangchen Pharmaceuticals issued an announcement. First, it will make an impairment provision for the goodwill formed by the acquisition of Tailing International’s equity; second, the “Annual Production of 500kg Anti-tumor API Production Base Construction Project” (hereinafter referred to as the “API Project”) is expected to be extended to December 2026. At the opening of December 17, Kangchen Pharmaceuticals’ stock price fell by more than 2%. As of the close, Kangchen Pharmaceuticals reported 25.9 yuan/share, down 3.61%, and the current market value is 4.144 billion yuan. In fact, Kangchen Pharmaceuticals has acquired Tailing International’s equity for four years. In April 2020, Kangchen Pharmaceuticals acquired 100% of Tailing International’s equity by paying 900 million yuan in cash, thereby obtaining the “Migaix” business. After acquiring Tailing International, Kangchen Pharmaceuticals has conducted impairment tests on the goodwill formed every year. As of now, the company has not made ...
According to Xinhua News Agency, Tianjin (reporters Zhang Jianxin and Bai Jiali), on December 16, Tianjin issued the first wholly foreign-owned tertiary general hospital medical institution practice license, and Perennial General Hospital (Tianjin Perennial Hospital) became the first wholly foreign-owned tertiary general hospital in my country. At the end of November this year, the National Health Commission, the Ministry of Commerce, the State Administration of Traditional Chinese Medicine, and the National Center for Disease Control and Prevention announced the “Pilot Work Plan for Expanding the Opening of Wholly Foreign-Owned Hospitals”. Previously, relevant departments have proposed to allow the establishment of wholly foreign-owned hospitals in Beijing, Tianjin, Shanghai and other places (except for traditional Chinese medicine, excluding mergers and acquisitions of public hospitals). Tianjin Perennial Hospital was invested and built by Singapore Perennial Group with a total investment of approximately RMB 1 billion and 500 beds. It not only has special ...
Ocaliva (obeticholic acid), which started as a blockbuster liver disease therapy and attracted much attention for its great potential in MASH treatment, will further fade away at the end of 2024. Not only did the “bad” news come one after another, but it also came from the two regulatory agencies covering the European and American markets, the FDA and the EMA. However, looking back at the development history of obeticholic acid, it is actually not smooth. Since it was approved for the treatment of primary cholangitis (PBC) in 2016, Intercept has tried twice to expand the drug to MASH, but both attempts failed. This made Intercept completely abandon the MASH project and lay off one-third of its employees. Later, Intercept was acquired by the Italian pharmaceutical company Alfasigma, but the change of destination did not improve the fate of obeticholic acid. And with the first PPAR agonist Elafibranor approved by ...
Drugdu.com expert’s response: The development process of a qualified medical device typically includes the following key steps: Ⅰ. Preliminary Preparations Business Registration: Register the company and clarify the business scope to prepare for future product production ranges and avoid subsequent changes. Team Formation: Establish a professional and efficient R&D team, including talents in mechanical engineering, electrical engineering, software engineering, etc., to ensure the technical feasibility of the product. Ⅱ. Product Development and Design Product Requirement Determination: Conduct market research, clinical application scenario analysis, doctor visits, etc., by the product manager to clarify the product’s functional requirements, performance requirements, and user expectations. System Requirement Determination: Convert product requirements into engineering technical indicators, complete the division of system functional architecture and constituent components, and output related requirements for regulations and standards, risk and safety, usability, serviceability, and manufacturability. R&D and Design: Based on system requirements, carry out structural design, sampling verification, and ...
Yingtai Medical (01501. HK) recently announced that the company has signed a letter of intent to acquire its target company Hangzhou Weiqiang Medical Technology Co., Ltd. and its affiliated group companies on December 18, 2024. According to the terms of the agreement, Yingtai Medical plans to acquire at least 51% of the controlling stake in Weiqiang Medical through capital increase, share expansion, and acquisition of shares from some shareholders. This transaction also stipulates that Yingtai Medical will inject no less than RMB 200 million in new funds into Weiqiang Medical after the acquisition is completed, and must pay a prepayment of RMB 30 million after the agreement takes effect. Weiqiang Medical has attracted much attention for its outstanding product development and clinical integration capabilities. In its product line, it includes Professor Guo Wei’s WeFlow Branch split type thoracic aortic stent graft from 301 Hospital, and Professor Fu Weiguo’s Fabulous stent ...
Recently, the National Medical Products Administration approved the registration applications for four innovative products: Changsha Huiwei Intelligent Medical Technology Co., Ltd. (hereinafter referred to as “Changsha Huiwei Intelligent”)’s “Intestinal Polyp Electronic Lower Digestive Endoscopy Image Assisted Detection Software”, Shanghai Minimally Invasive Melody Medical Technology Co., Ltd. (hereinafter referred to as “Minimally Invasive Melody”)’s “Spinning Intervention Therapy Device” and “Disposable Coronary Spinning Grinding Catheter”, and Hunan Aptech Medical Equipment Co., Ltd. (hereinafter referred to as “Aptech Medical”)’s “Disposable Magnetoelectric Positioning Pressure Monitoring Pulse Electric Field Ablation Catheter”. Changsha Huiwei Intelligence, another heavyweight product approved Changsha Huiwei Intelligent was established in 2020 and is a wholly-owned subsidiary of Suzhou Huiwei Intelligent Medical Technology Co., Ltd. (hereinafter referred to as “Huiwei Intelligent”). Huiwei Intelligent was established in June 2019, specializing in the research and development, production, and sales of intelligent medical products. Driven by independent core technologies in the fields of “artificial ...
Today, LIB Therapeutics announced that it has submitted a biologics license application (BLA) to the U.S. FDA, seeking approval for its third-generation PCSK9 inhibitor lerodalcibep to lower low-density lipoprotein cholesterol (LDL-C) to treat patients with atherosclerotic cardiovascular disease (ASCVD), as well as patients with very high or high ASCVD risk and primary hyperlipidemia (including heterozygous and homozygous familial hypercholesterolemia, HeFH/HoFH). At the same time, LIB Therapeutics is preparing to submit a marketing application (MAA) to the European Medicines Agency (EMA), which is expected to be completed in mid-2025. Cardiovascular disease (CVD) affects hundreds of millions of people worldwide, and the number of related deaths exceeds the sum of cancer, chronic lung disease and diabetes. It is estimated that by addressing the factors that cause or aggravate CVD, about 80% of premature deaths caused by CVD can be prevented. ASCVD accounts for approximately 85% of all cardiovascular deaths. ASCVD is caused ...
The results of the credit evaluation of pharmaceutical recruitment have come out again, and the companies and varieties involved in bribery have also been announced. On December 9, the Shandong Provincial Public Resources Trading Center issued the “Announcement on the Pharmaceutical Price and Procurement Credit Evaluation Results of Shenyang Xinma Pharmaceutical Co., Ltd.” Guiding Opinions” (Mibaofa [2020] No. 34), “Operating Standards for Pharmaceutical Prices and Recruitment Credit Ratings (2020 Edition)”, “Discretionary Benchmarks for Pharmaceutical Prices and Recruitment Credit Ratings (2020 Edition)”, Shandong Provincial Public Resources Under the guidance of the Shandong Provincial Medical Insurance Bureau, the trading center conducts credit rating assessments on pharmaceutical prices and behaviors that are inconsistent with good faith in the list of untrustworthy matters in recruitment and procurement. Along with the announcement, “About Shenyang Xinma Pharmaceutical Co., Ltd. Medicine Price and Recruitment Credit Evaluation Results” was released. The content showed that the type of untrustworthy ...
On December 16, Xinweida Bio announced that the company’s application for marketing authorization for the new indication of the Class 1 new drug Ecnoglutide Injection was accepted by the CDE for long-term weight management of adult patients on the basis of controlling diet and increasing physical activity. Ecnoglutide Injection is the world’s first new long-acting GLP-1 agonist with cAMP bias independently developed by Xinweida Bio. Its three China Phase III registered clinical studies on adult type 2 diabetes and obesity have been successfully completed, and some results have been published at the American Diabetes Congress and the European Diabetes Congress. The completed clinical data confirmed that Ecnoglutide Injection has excellent therapeutic effects on patients with type 2 diabetes and obesity, and shows good safety and tolerability. In November this year, the indication of Ecnoglutide for blood sugar control in adult patients with type 2 diabetes has been submitted for marketing. ...
One year after his retirement, Zuo Guoqing, former member of the Party Committee and president of Chongqing Chinese Medicine Hospital, was investigated for suspected serious violations of discipline and law. Recently, the Chongqing Municipal Commission for Discipline Inspection and Supervision announced this news. Public information shows that Zuo Guoqing is 61 years old, a chief physician, professor, doctoral supervisor, master of medicine and master of business administration, and an expert enjoying special government allowances from the State Council. He has worked in the field of gastroenterology for more than 20 years and served as the vice president of the Second Affiliated Hospital of Chongqing Medical University. He has a profound influence in the medical field in Chongqing. Since 2012, Zuo Guoqing has been transferred to the president of Chongqing Chinese Medicine Hospital. Chongqing Chinese Medicine Hospital is a century-old hospital with a history of more than 120 years. It is ...
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