Regeneron is a role model for the biotech community. No biotech company wants to be Regeneron. “Becoming China’s Regeneron” is the slogan of many domestic biotechs. However, such a Regeneron cannot escape its midlife crisis. The attack of opponents, the victory of Eylea generic drugs, and the successive blows of dual-antibodies have put Regeneron in an extremely delicate stage. On the one hand, with two blockbuster drugs, Regeneron has completed the transformation from biotech to big pharma. In the first half of the year, its stock price continued to rise, successfully breaking through the $100 billion threshold, and its market value reached $133.2 billion. On the other hand, although the market believes in Regeneron’s R&D and platform technology capabilities, how can a new billion-dollar blockbuster drug be so easy? And Regeneron’s highly anticipated oncology business is not as glamorous as autoimmunity and ophthalmology, and its progress is also lackluster. So ...
Eight months after leaving office, Liu Qunyou, former Party Secretary of the First People’s Hospital of Xiangtan City, Hunan Province, was investigated. According to the Xiangtan Municipal Commission for Discipline Inspection and Supervision on November 12, Liu Qunyou was suspected of serious violations of discipline and law, and took the initiative to explain the problem to the organization. He is currently undergoing disciplinary review and supervision investigation. Public information shows that Liu Qunyou is 60 years old, from Xinning, Hunan Province, with a bachelor’s degree, deputy chief physician, master’s tutor, graduated from Tongji Medical College of Huazhong University of Science and Technology, and is an in-service graduate student of Xiangya Medical College of Central South University. After graduating from university in 1986, he was assigned to Xiangtan First People’s Hospital and worked in the medical field for 38 years. In March this year, 60-year-old Liu Qunyou resigned from the post ...
On November 14, 2024, Zhang Ke, secretary of the Party Leadership Group and director of the National Medical Insurance Bureau, went to Xicheng District, Beijing to investigate medical insurance work. He visited the Xicheng District Medical Insurance Bureau and the Medical Insurance Affairs Management Center to learn more about the total budget management of medical insurance funds, the settlement process with designated medical institutions, and the allocation of funds. Zhang Ke said that the medical insurance department of Beijing should take the lead in trialing and innovating the settlement methods of medical insurance funds, and explore the construction of a scientific medical insurance settlement system based on direct settlement, instant settlement, and synchronous settlement. It is necessary to actively promote direct settlement and instant settlement between medical insurance and hospitals, pharmaceutical companies, and equipment and consumables manufacturers. For a long time, the long collection cycle has imposed a heavy financial ...
Drugdu.com expert’s response: The inquiry of drug registration standards typically involves multiple levels and channels. Here are some suggested methods and avenues for inquiry: Ⅰ. Methods of Inquiry Official Website Inquiry: (1) CDE (National Medical Products Administration’s Center for Drug Evaluation) Website: CDE is responsible for the evaluation of drug registration applications, and its website usually publishes information related to drug registration. Through sections such as “Information Disclosure” or “Application Directory Browsing” on the CDE website, you can inquire about the overall acceptance status of drug registration applications and the progress of evaluation and approval. Additionally, CDE provides specific inquiry services for the acceptance, evaluation, and approval progress of drug registration applications, and applicants can inquire through the “Applicant’s Window” section. (2) National Medical Products Administration Website: The National Medical Products Administration is the authoritative agency for drug registration approval, and its website also publishes information and policies related to ...
On November 18th, VelaVigo Cayman Limited announced a global strategic partnership agreement with Avenzo Therapeutics, Inc. (Avenzo). According to the agreement, Orange Sail Pharmaceuticals will grant Avenzo the development, production, and commercialization of Nectin4/TROP2 bispecific antibody conjugates worldwide (excluding Greater China), while retaining relevant rights in Greater China. Both parties will jointly promote the development and clinical application of the project on a global scale. The project plans to submit an IND to the US Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA) of China by 2025. According to the terms of the agreement, Orange Sail Pharmaceuticals will receive a down payment of up to $50 million and recent milestone payments. After achieving key milestones in development, regulatory approval, and sales, the company is expected to receive up to $750 million in follow-up milestone payments and tiered royalty payments based on sales in the Avenzo region. ...
Jingtai Technology, which has the halo of being the “first AI pharmaceutical stock” in China, has attracted considerable attention in the secondary market. In the past few months, it has always sparked discussions within the industry due to occasional breakthroughs. According to Wind, on November 19th, Jingtai Technology’s lowest intraday price was HKD 3.51 per share, hitting a new low since its listing. The closing price for the day was HKD 4.00 per share, a drop of 12.66%. Compared to its issue price of HKD 5.28 per share, it has dropped 24.24%. In fact, since September this year, the stock price of Jingtai Technology has shown an overall fluctuating downward trend. According to the official website of Jingtai Technology, it is an innovative research and development platform company driven by artificial intelligence (AI) and robots. Based on technologies and capabilities such as quantum physics, artificial intelligence, cloud computing, and large-scale ...
According to the Medicine Intelligence Data Investment Pattern Database, Yangqi Medical Chip, committed to becoming a pioneer in precision nuclear medicine, recently announced the completion of tens of millions of yuan in PreA round financing. This round of financing is led by Anfeng Venture Capital, and the raised funds will mainly be used for market promotion of approved products, approval of new product research and development, and expansion of the pet radiotherapy market. Yangqi Medical Core was established in 2021, and its core founding team is composed of clinical experts in nuclear medicine, nuclear physics and artificial intelligence, tumor radiotherapy, and radiation physics from Stanford, Alibaba, and other domestic and foreign institutions. The company is headquartered in Shenzhen and has research and development centers in Hangzhou and Shanghai. It is reported that Yangqi Medical Core is deeply involved in the fields of nuclear medicine and tumor radiation therapy. In response ...
Recently, the Equipment Review Center of the National Medical Products Administration released the results of the priority approval application for medical devices (No. 14 of 2024), and Shanghai Qigong Medical Technology Co., Ltd. (hereinafter referred to as Qigong Medical)’s product – endovascular stent – passed the priority approval green channel. It is worth mentioning that this product is urgently needed in clinical practice and there are no registered medical devices of the same variety in China. Qigong Medical focuses on innovative vascular intervention products Against the backdrop of an aging population, the incidence of cardiovascular diseases in China continues to rise, with high mortality rates, difficult treatment, and high risks associated with aortic disease. At present, the clinical treatment options for aortic diseases in China mainly include surgical open treatment and endovascular intervention treatment. Endovascular intervention therapy is a rapidly developing clinical treatment technique in recent years, which combines a ...
On November 14, the Shanxi Provincial Drug and Equipment Centralized Bidding and Procurement Center issued the “Notice on the Adjustment and Disposal of the Price of the Centralized Procurement of Amoxicillin and Other Drugs in the Guangdong Alliance” (hereinafter referred to as the “Notice”). It is worth noting that there are still 11 manufacturers and 20 specifications that refuse to reduce prices for rectification, including well-known pharmaceutical companies, including AstraZeneca, Sanofi, Eli Lilly and other foreign pharmaceutical companies, and their products include well-known brand drugs such as Plavix (clopidogrel bisulfate tablets), Iressa (gefitinib tablets), and Alimta (pemetrexed disodium for injection). The “Notice” emphasizes that the relevant drugs that refuse to accept the price rectification requirements will be disqualified from being selected and the selected price will be disqualified, and will be transferred to the alternative catalog. The platform will increase price risk warnings, and the task volume of the centralized ...
After four months of deliberation, the European Medicines Agency (EMA) has “changed its mind” on Lencanermab. On November 14, the EMA Committee for Medicinal Products for Human Use (CHMP) announced that after re-examining Lencanermab, it recommended approval of Lencanermab for the treatment of mild cognitive impairment or mild dementia caused by Alzheimer’s disease, suitable for apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers. According to regulations, the European Commission is expected to make a final ruling on the marketing authorization application for Lencanermab within the next 67 days. Of course, the European Commission is not in a good position to raise objections, so it is equivalent to approval. Although we had expected this result four months ago, it can be imagined that there were a lot of discussions in the middle. Foreign media commented that “EMA’s attitude towards Lencanermab has reversed 180 degrees.” This time, after Eisai/Biogen submitted the subgroup ...
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