Recently, Fosun Pharma (stock code: 600196.SH; 02196.HK) announced that its subsidiary, Fosun Pharma Industry, plans to invest $27 million in cash to acquire 50% of the equity of Fosun Kite held by Kite Pharma. Once this equity transfer is completed, Fosun Pharma will wholly own Fosun Kite and plans to invest an additional $10 million or its equivalent in renminbi as a capital increase for Fosun Kite. On the same day the equity transfer agreement was signed, Fosun Kite and Kite Pharma comprehensively revised and restated their original licensing agreement, signing a “Revised and Restated Licensing Agreement.” According to this agreement, Fosun Kite has obtained exclusive rights to develop, produce, and commercialize Yescarta® and Brexu-Cel (Fosun Kite’s research project FKC889) in mainland China, Hong Kong, and Macau, and within the field of cancer treatment. Additionally, Fosun Kite plans to change its name to Fosun Kairui and will function as Fosun ...
LY-M003 Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. Recently, a prospective, single center, open label, single arm, single dose clinical study evaluating the safety, tolerability, and efficacy of LY-M003 injection in the treatment of adult patients with Wilson’s disease was launched at the First Affiliated Hospital of Zhejiang University School of Medicine (hereinafter referred to as “Zhejiang First Hospital”). The project was led by Professor Yu Chaohui, the leader of the Gastroenterology Department, as the main researcher. LY-M003 injection is an innovative gene therapy drug developed by Lingyi (Hangzhou) Biotechnology Co., Ltd. (hereinafter referred to as “Lingyi Biotechnology”). The Department of Gastroenterology at Zhejiang First Hospital ...
biopharmaceutical era Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. On September 11th, Johnson&Johnson announced that the US FDA has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. According to the press release, Tremfya is the first dual acting mechanism interleukin-23 (IL-23) inhibitor approved for the treatment of active ulcerative colitis. In the critical QUASAR project, the drug demonstrated a highly statistically significant endoscopic response rate. The approval of Tremfya this time is supported by data from the ongoing Phase 2b/3 QUASAR study, which evaluates the efficacy and safety of Tremfya in adult patients with moderate to severe ...
In response to whether the bill is feasible, the FDA once said, “If there is not enough data to calculate which APIs come from China, what proportion and how much impact, no one can guarantee that there will not be fatal drug shortages, and no one is willing to take such responsibility.” Now, the API industry base survey and assessment initiated by the U.S. Department of Commerce is a comprehensive survey of industry data, which means possible variables in the future. According to reports, in July this year, the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce officially announced that it would cooperate with the Strategic Preparedness and Response Administration (ASPR) under the U.S. Department of Health and Human Services (HHS) to conduct a comprehensive investigation and assessment of the U.S. active pharmaceutical ingredients, or API industry base. The survey aims to understand the supply chain ...
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 ...
Drugdu.com expert’s response: The reasons for requiring CE certification in domestic medical device tenders can be elaborated from multiple perspectives: Ⅰ. International Recognition and Market Access of CE Certification International Recognition: CE certification is a prerequisite for market access in Europe. Medical devices with CE certification must comply with European standards such as EN60601 and EN45545. This signifies that CE certification not only enjoys a high level of recognition in the European market but is also globally recognized as an important indicator of product quality and safety. Market Access: For medical device manufacturers aiming to enter the European market, CE certification is indispensable. Without the CE mark, it is illegal to sell or distribute medical devices within the European Economic Area. Therefore, requiring CE certification for domestic medical devices in tenders helps enhance their competitiveness in international markets. Ⅱ. Enhancing Product Quality and Safety Quality Improvement: To obtain CE certification, ...
Today (September 2nd), Shanghai Yinghe Yimai Intelligent Technology Co., Ltd. (hereinafter referred to as “Yinghe Yimai”) announced the completion of an angel round financing of tens of millions of yuan, led by CICC Capital, marking a solid step forward for Yinghe Yimai in promoting the intelligentization of medical imaging. Multiple core products, focusing on intelligent medical imaging Yinghe Medical Pulse was founded in 2020 and is a continuous innovator in the field of medical imaging artificial intelligence based on its newly developed MIIA base model. In response to the current situation where medical imaging AI products are generally single disease, fragmented, and homogeneous, and cannot meet the actual needs of image reading work, Yinghe Medical Pulse is an emerging technology enterprise focused on medical imaging AI integration and research and development. It is committed to providing medical imaging auxiliary tools based on AI and statistical methods, as well as medical ...
1. The more you open, the more you lose In the past few years, drug stores have sprung up all over the country. Whether it is a first-tier city or a small county town, you can see a drug store almost every 50 meters, and there are at least three drug stores at the entrance of a community. The “proliferation” of drug stores has exceeded many people’s imagination. By the end of 2023, there will be nearly 700,000 retail pharmacies in my country, which is more than 100,000 more than the milk tea shops that are everywhere on the streets. In 2012, there were only 440,000 drug stores in my country. In 12 years, the number of drug stores has increased by nearly 50%. Although milk tea shops and snack shops have sprung up in the streets and alleys, they are nothing compared to the expansion speed of chain drug ...
1. Cycles exist objectively, but they are not impossible to cross In recent years, the concept we first used was the “new normal”. The term “new normal” actually lowers social expectations in advance. Later, many experts introduced the concept of “cycle” with the intention of incorporating the current economic situation into a historical cycle. Admittedly, economic development has cycles, and even the spread of viruses has cycles. However, “today’s economic and social conditions should mainly be the result of active choices made by decision-makers. Cyclical factors have an effect but are not decisive, or the adjustment of development direction “encounters” cyclical factors”-excerpted from Du Chen’s “Our Times and Us in the Times”. 2. The current difficulties may only be the initial stage The “new cycle” has just begun, and we must be prepared for long-term hard work. Combining data from the National Bureau of Statistics, Minnet, IQVIA, etc., the average ...
Though the UK became the first country in Europe to authorize use of Eisai and Biogen’s early Alzheimer’s disease drug, Leqembi (lecanemab), patients in the UK’s National Health Services (NHS) will not gain access to the drug as the anti-amyloid treatment was deemed too costly. As per the 22 August draft guidance consultation released by the National Institute for Health and Care Excellence (NICE), an independent committee found that the cost effectiveness estimates were “considerably above what NICE considers an acceptable use of NHS resources.” The committee cited a lack of evidence on the long-term effects of treatment with Leqembi and the costs of providing treatment infusions, monitoring side effects, and determining when to terminate treatment as uncertainties. According to the guidance, NICE has requested additional information from Eisai and NHS England to address the uncertainties and will consider the additional information alongside stakeholder comments in a second meeting. In ...
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