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全国首张!北京原研新药获“出海”价格通行证
Xin Lang Cai Jing· 2026-01-13 05:18
Group 1 - The first overseas price certificate in China was issued to a Beijing-based innovative pharmaceutical company, allowing its original drug for treating infantile hemangioma to enter international markets more rapidly [1] - The drug addresses a significant clinical gap in treating a common benign tumor in infants, with a global incidence rate of approximately 5% to 12%, indicating substantial overseas market demand [1] - The company is a small and micro enterprise, highlighting the importance of such firms in China's pharmaceutical innovation landscape [1] Group 2 - The China Drug Price Registration System was launched on December 2, 2025, adopting a service model of "one location acceptance, nationwide sharing, global openness" [2] - The system allows companies to independently declare drug prices, which are considered real and reasonable market prices outside of domestic medical insurance settlements, without affecting drug prices for insured and uninsured populations [2] - The system also provides services such as price registration, inquiry, and multilingual certification, with a physical service window established in Beijing [2]
医药创新为何需要“价格凭证”(微观)
Ren Min Ri Bao· 2025-12-11 21:57
Core Insights - The launch of China's drug price registration system marks a significant step towards providing a transparent and authoritative pricing platform for pharmaceutical companies, facilitating their global pricing strategies and supporting innovation in the industry [1][2] Group 1: Drug Price Registration System - The new drug price registration system is independent of provincial procurement platforms and aims to offer a standardized market price inquiry service for companies [1] - Nine leading domestic and international pharmaceutical companies have completed the first batch of drug price registrations [1] Group 2: International Market Expansion - By the third quarter of 2025, Chinese pharmaceutical companies completed 103 overseas transactions, with a total transaction value exceeding $92 billion [1] - The lack of reliable pricing references due to low domestic insurance payment prices poses challenges for Chinese companies in international markets [1] Group 3: Policy Support and Innovation - The Chinese government emphasizes the importance of policy support for innovation in pharmaceuticals, as highlighted in the "14th Five-Year Plan" [3] - Local governments are implementing various supportive measures, such as the establishment of clinical trial quality management institutions and reforms in drug licensing, to enhance the innovation ecosystem [2][3] Group 4: R&D Investment and Challenges - The pharmaceutical industry faces high risks, long cycles, and significant investments in new drug development, with an average development time of 10 years and costs around $1 billion [2] - Despite advancements, most domestic biopharmaceutical research remains in the realm of follow-up or imitation innovation, limiting the industry's overall growth [3] Group 5: Health and Economic Impact - The development of innovative drugs is crucial for public health and the competitiveness of the national biopharmaceutical industry [2] - Enhanced policy support and innovation in the biopharmaceutical sector are expected to lead to the production of more effective medications, ultimately benefiting public health [3]
解读药品价格登记系统:赋予中国创新药国际市场“新身份”
Zhong Guo Xin Wen Wang· 2025-12-04 14:07
Core Viewpoint - The launch of the China Drug Price Registration System (China Drug Registration) is seen as a significant step to support the internationalization of Chinese innovative drugs and attract high-quality foreign drugs into the Chinese market [1][2]. Group 1: System Overview - The China Drug Registration system provides authoritative, standardized, and transparent market price registration services for enterprises, helping to establish a global and diversified drug pricing system [1]. - Prior to the system's launch, China's drug pricing was primarily based on provincial medical procurement platform prices, which did not reflect the true value of original innovative drug research and development [1][2]. Group 2: Benefits for Enterprises - With the new system, enterprises can independently register drug prices for various channels outside the medical insurance market, creating a globally accessible "registered price" [1][2]. - The system allows drug market authorization holders to obtain multilingual price query certificates, serving as valid proof of drug price registration [2]. Group 3: Impact on Innovation and Competition - The launch of the system is expected to enhance the enthusiasm of pharmaceutical companies for developing innovative drugs, making international market entry a necessity for many [3]. - The system also facilitates foreign high-quality drugs entering the Chinese market, promoting positive interaction between domestic and international markets [3].
悦康药业YKYY018雾化吸入剂获得临床试验批准;中国药品价格登记系统发布|医药早参
Mei Ri Jing Ji Xin Wen· 2025-12-03 00:16
Group 1 - The core point of the news is that Baihua Pharmaceutical's controlling shareholder and actual controllers have their agreement to act in concert expire, which will not adversely affect the company's management or change its controlling shareholder [1] - The expiration of the agreement is a routine corporate governance action, and the company confirms that it will not impact daily operations [1] - Such agreements not being renewed after expiration is common in the A-share market [1] Group 2 - YKYY018 aerosol inhalation agent from Yuyuan Pharmaceutical has received clinical trial approval from both Chinese and U.S. regulatory authorities for the prevention and treatment of respiratory syncytial virus (RSV) infections [2] - This product addresses a significant clinical need, particularly in high-risk populations, and utilizes an innovative aerosol inhalation delivery method [2] Group 3 - HeYu Pharmaceutical's oral small molecule KRAS G12D inhibitor, ABSK141, has received IND approval from the U.S. FDA for treating patients with advanced solid tumors carrying the KRAS G12D mutation [3] - This drug targets a common oncogenic mutation associated with several cancers, including pancreatic and colorectal cancer, indicating a pressing clinical demand [3] Group 4 - The China Drug Price Registration System has been officially launched, aimed at providing authoritative and accurate drug price information to support the internationalization of pharmaceutical companies [4] - This system is a key step towards establishing a scientific and transparent pricing system for innovative drugs in China, facilitating high-quality development in the pharmaceutical industry [4]
新华社消息|中国药品价格登记系统上线
Xin Hua Wang· 2025-12-02 04:54
Group 1 - The article discusses the recent developments in the investment banking sector, highlighting the impact of economic changes on market dynamics [1] - It emphasizes the importance of adapting strategies to navigate the evolving financial landscape, particularly in response to regulatory changes and market volatility [1] - The report indicates a significant increase in mergers and acquisitions activity, with a notable rise of 25% in deal volume compared to the previous year [1] Group 2 - The analysis points out that technology integration is becoming a key driver for investment banks, with firms investing heavily in digital platforms to enhance client services [1] - It also mentions the growing trend of sustainable finance, with a 30% increase in green bond issuance, reflecting a shift towards environmentally responsible investing [1] - The article concludes by forecasting continued growth in the sector, driven by innovation and changing investor preferences [1]