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Zhengda Tianqing’s Anlotinib Application for Ninth Indication Accepted by CDE

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 ...
- Source: drugdu
- 95
- October 22, 2024
Folagliptin benzoate tablets

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 ...
- Source: drugdu
- 77
- October 22, 2024
Abbott joins the PFA melee

Recently, Abbott announced its latest progress in electrophysiology pulsed field ablation (PFA). Specifically, the global IDE registration of the Volt™ PFA system was completed ahead of schedule; the tactical flex™ Duo ablation catheter Sensor Enabled™ is undergoing the global FOCALFLEX trial; the Advisor™ HD Grid X mapping catheter Sensor Enabled™ has been approved by the US Food and Drug Administration and has begun commercial release. According to Abbott’s official website, the above two catheters are being developed as important tools for doctors to treat patients with abnormal heart rhythms such as atrial fibrillation (AFib). Among them, the mapping catheter will further support the mapping of PFA and radiofrequency ablation cases, and the visualization of cardiac anatomy is crucial for patients undergoing ablation surgery to achieve the best results. It is reported that the enrollment of the US VOLT-AF IDE study was completed 4 months ahead of schedule, and nearly 400 ...
- Source: drugdu
- 113
- October 22, 2024
The state has issued documents many times, and the anti-corruption crackdown in the pharmaceutical industry has been launched frequently.

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, ...
- Source: drugdu
- 103
- October 22, 2024
【EXPERT Q&A】What is the process for medical device export?

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 ...
- Source: drugdu
- 107
- October 21, 2024
Four consecutive A! Prolo Pharmaceutical received the highest evaluation for its information disclosure work on the Shenzhen Stock Exchange again

Recently, the Shanghai and Shenzhen Stock Exchanges released the evaluation results of information disclosure for the years 2023-2024, and Prolo Pharmaceutical (stock code: 000739) received the highest rating of A in the annual information disclosure evaluation of listed companies on the Shenzhen Stock Exchange. Prolo Pharmaceutical has won this honor for four consecutive years, fully reflecting the high recognition of the securities regulatory authorities for the company’s standardized operation level, information disclosure quality, and investor relations management.The evaluation of information disclosure work on the Shenzhen Stock Exchange is a comprehensive assessment of multiple dimensions such as internal governance, information disclosure quality, investor relations management, and social responsibility fulfillment of listed companies. It is an important indicator for measuring the level of governance and information disclosure quality of listed companies. Listed companies that receive A-level evaluations can not only enhance the recognition of the capital market, but also enjoy policy support ...
- Source: drugdu
- 90
- October 21, 2024
2.5 billion+2.3 billion! Sanofi adds more nuclear weapons

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 ...
- Source: drugdu
- 100
- October 21, 2024
Large pharmaceutical companies, change of controlling shareholders

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 ...
- Source: drugdu
- 85
- October 21, 2024
Countdown to the 2024 medical insurance negotiations, these drugs are the focus

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. ...
- Source: drugdu
- 101
- October 21, 2024
Huawei enters the hot track of medical devices

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, ...
- Source: drugdu
- 84
- October 21, 2024

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