According to a report from Zhengda Tianqing, the company has recently submitted a marketing application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration for its self-developed Class I innovative drug, anlotinib hydrochloride capsules, in combination with chemotherapy for treating advanced unresectable or metastatic soft tissue sarcoma. This application has been accepted. Zhengda Tianqing noted that there are currently no officially approved combination therapies for first-line treatment of advanced soft tissue sarcoma globally. The Phase III clinical study (ALTN-III-04) evaluating the use of anlotinib hydrochloride capsules in combination with chemotherapy for first-line treatment of advanced unresectable or metastatic soft tissue sarcoma has achieved its pre-specified primary efficacy endpoint, as assessed by an Independent Data Monitoring Committee (IDMC). This study is the first key Phase III research globally to utilize an anti-angiogenic drug in combination with chemotherapy. At present, anlotinib hydrochloride capsules have received approval for six ...
According to the authoritative forecast of the International Diabetes Federation, the number of diabetes patients in China may increase to 174 million in 2045! This number really shocked the Chinese people. Are there really so many? You know, the number of diabetes patients in China in 2023 will reach 141 million, with an incidence rate of 12.8%. The number of diabetes patients in China ranks first in the world! In recent years, diabetes has become younger in China. According to a report in 2020, the prevalence of diabetes among residents aged 18 and above in China has reached 11.9%. This set of data once again sounded the alarm for the health of the Chinese people! You should know that diabetes is a chronic disease, and its typical symptoms are “three more and one less”. “Three more” means drinking more, eating more, and urinating more; “one less” mainly refers to weight ...
Recently, the National Medical Insurance Administration reported on the unannounced inspection of Wuxi Hongqiao Hospital in Jiangsu Province, and made it clear that the next step will be to guide the Jiangsu Provincial Medical Insurance Administration to conduct a comprehensive investigation in the local area. At the same time, it will organize a special action to severely crack down on fraud and insurance fraud across the country to focus on rectifying the unhealthy trends and corruption problems around the people in the medical insurance field. On October 10, the State Drug Administration issued the “Notice on Rewarding Internal Whistleblowers on Drug and Medical Device Quality and Safety (Draft for Comments)” (hereinafter referred to as the “Reward for Reporting”) for public comments. The “Reward for Reporting” clearly states that the announcement applies to reporting major violations of drug and medical device quality and safety to the drug supervision and management department, ...
Drugdu.com expert’s response: The process of exporting medical devices involves multiple steps, as detailed below: Ⅰ. Market Research and Preparation Target Market Research: Conduct in-depth research on the medical device demand, regulations, standards, and competitors in the target market. Understand factors that may affect transactions, such as the target market’s political stability, trade policies, and currency exchange rate fluctuations. Product Registration and Certification: Complete product registration and certification according to the regulatory requirements of the target market. For example, the European market requires CE certification, and the US market requires FDA registration. Ensure that the products comply with the regulations and standards of the destination country to avoid trade barriers and compliance risks. Establishing a Sales Network: Establish contact with distributors, agents, or medical institutions in the target market. Participate in international exhibitions, seminars, and other events to communicate face-to-face with potential customers and showcase product advantages. Ⅱ. Production and ...
Original Xie Ling Arterial New Medicine October 18, 2024 08:27 Chongqing Yesterday (October 17th), Sanofi announced that it has reached an agreement with Orano Med, a subsidiary of the Orano Group, to further accelerate the development of next-generation radioligand therapy (RLT) by leveraging their expertise in combating rare cancers. According to the agreement, Sanofi and Oueno will jointly invest in a new entity operated under the Oueno Medical brand, focusing on the discovery, design, and clinical development of next-generation radioligand therapy (RLT) based on lead-212 (①¹² Pb) alpha emitting isotopes. Sanofi will make an equity investment of 300 million euros (approximately 2.313 billion yuan), accounting for approximately 16% of the equity of the new entity Orano Medical, with a valuation of 1.9 billion euros (approximately 14.648 billion yuan). At the beginning of last month, Sanofi announced a licensing agreement with RadioMedix and Orano Med for RLT, focusing on AlphaMedix, a ...
On October 17, Zhejiang Inter Group issued the “Indicative Announcement on the Change of Controlling Shareholders and Exemption from the Offer for this Transaction”. Huachen Investment transferred nearly 122 million shares of Inter Group held by it to Zhejiang Pharmaceutical and Health Industry Group, the controlling shareholder of Huachen Investment, free of charge; at the same time, Zhejiang International Trade Group entrusted the voting rights corresponding to nearly 151 million shares of Inter Group held by it to Zhejiang International Trade’s wholly-owned subsidiary Zhejiang Pharmaceutical Group for exercise. After this change of rights and interests, Zhejiang Pharmaceutical Group can actually control the voting rights corresponding to nearly 322 million shares of Inter Group. As of September 30, 2024, it accounts for 61.67% of Inter Group’s total share capital. So far, the controlling shareholder of Inter Group has changed from Zhejiang International Trade to Zhejiang Pharmaceutical Group, and the actual controller ...
According to multiple sources in the industry, from October 16 to 18, the National Medical Insurance Administration conducted pre-negotiations with companies that passed expert reviews. As in last year, “pre-negotiations” give companies ample opportunities for communication. Before the formal negotiations, the National Medical Insurance Administration specially organized experts and companies that intend to participate in the negotiations to fully communicate around the payment standard calculations for the intended negotiated products. The medical insurance party and the enterprise party first go through a round of “pre-negotiations” before the formal negotiations, which can facilitate the enterprise party to more fully understand the negotiation rules, and when the formal negotiations are held, the results will be relatively ideal. Previously, the National Medical Insurance Administration had organized fund calculations and pharmacoeconomic calculations in Xiaotangshan, Beijing. On September 19, the National Medical Insurance Administration held an on-site communication meeting for companies to negotiate/bid in Beijing. ...
Recently, the website of the State Intellectual Property Office updated a new invention patent, named “Method for controlling stimulator, stimulator, brain-computer interface system and chip”, and the inventor of the patent is Huawei Technologies Co., Ltd. It is reported that this is Huawei’s second brain-computer interface related patent. As early as June 2023, Huawei announced a patent called “A brain-computer interface device and information acquisition method”. Brain-computer interface is one of the most popular phenomenal technologies in recent years, and its potential in the medical field is highly expected by the industry. According to McKinsey’s calculations, the potential market size of global brain-computer interface medical applications is expected to reach US$40 billion in 2030, and it is expected to exceed the US$145 billion mark by 2040. With the increase in R&D investment, the medical application of brain-computer interface has gradually shifted from early abstract concepts to landing results. In September, ...
On October 15, Yaoshibang issued an announcement that it had signed a transaction agreement to acquire 100% of the equity of Yikuai Pharmaceutical, with a total consideration of RMB 1.035 billion, including a cash consideration of RMB 420 million and a share consideration of RMB 615 million. In the pharmaceutical industry, where mergers and acquisitions are common, this transaction with a total price of RMB 1 billion has attracted considerable attention. The reason is that this is not only the first large-scale acquisition of Yaoshibang, a pharmaceutical B2B e-commerce unicorn, since its listing, but also related to Yaoshibang’s own financial situation. Amid the tightening of listing, Yaoshibang successfully rang the bell on the Hong Kong Stock Exchange in June 2023. However, as a “digital enterprise that deeply cultivates the outpatient market” that went public at a loss, Yaoshibang had just turned a profit when it handed in its full-year performance ...
This is the title of an article published in Nauter in February this year (Move over, CRISPR: RNA-editing therapies pick up steam). RNA editing technology, which is coming to the fore, is seen as a potential to surpass CRISPR due to its safer and more flexible characteristics. The technology is in its infancy, and the bets of MNCs such as Eli Lilly and GSK have once pushed its popularity to a climax. However, Wave, an RNA editing pioneer founded in 2012, took more than 10 years to push its first RNA editing project WVE-006 into clinical trials. During this period, due to the clinical failure of other nucleic acid drugs, Wave’s stock price fell from a high of US$56 per share to around US$1 per share, and market expectations were no longer met. After years of silence, a counterattack driven by clinical data is taking place. On October 16, Wave ...
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