Core Insights - China's economy has shown strong resilience and vitality amid complex international environments and domestic transformation pressures, with significant achievements in high-quality development over the past five years [1] - The "Decode Vitality China" series by Securities Times aims to explore the internal driving forces of China's economic development through in-depth reporting on key regions, industries, and leading enterprises [1] Industry Developments - The pharmaceutical industry in China is experiencing a surge in business development (BD) activities, with over $60 billion in BD transactions in the first half of the year, surpassing the total for 2024 [3] - The partnership between Heng Rui Medicine and GlaxoSmithKline could yield a potential total of $12 billion if all projects are executed successfully [3] - From 2015 to 2024, China has entered the top tier of global new drug research and development, surpassing the United States in the number of original new drugs [4] Company Innovations - Guangsheng Tang has invested approximately 999 million yuan in R&D since its listing in 2015, leading to the approval of its innovative drug Tai Zhong Ding in 2023 [5] - Hai Te Biotechnology's new drug Sha Ai Te has entered the medical insurance directory, marking a significant achievement for the company [6] Policy and Market Dynamics - New policies aimed at supporting high-quality development of innovative drugs have been released, addressing key industry pain points such as pricing standards and reimbursement mechanisms [7] - The innovative drug sector has seen a positive market response, with the Innovative Drug 50 ETF rising over 40% in the past year [7] - There are suggestions for policy adjustments regarding the inclusion of combination therapies in medical insurance, which could alleviate patient burdens [8]

Core Viewpoint - Bi Jingquan, a key figure in China's drug review reform, is under investigation for serious violations of discipline and law, which may impact the pharmaceutical industry and regulatory environment in China [2]. Group 1: Background and Career - Bi Jingquan was born in September 1955 and graduated from Peking University in 1978, starting his career at the National Price Bureau in 1982 [2]. - He worked in the National Development and Reform Commission (NDRC) from 1994 and served as the State Council's Deputy Secretary-General in 2008, later moving to the drug regulatory system [2]. - He is recognized for significant reforms in China's pharmaceutical industry, particularly during his tenure as the head of the former State Food and Drug Administration (SFDA) [2]. Group 2: Key Reforms and Initiatives - Under Bi's leadership, the SFDA implemented several reforms, including speeding up drug review and approval processes, promoting consistency evaluations for generic drugs, and piloting the Marketing Authorization Holder (MAH) system [2][3]. - In July 2015, the SFDA addressed long-standing issues of clinical trial data fraud, marking a significant step in drug approval reform [3]. - The introduction of the MAH system in June 2016 aimed to stimulate innovation in drug development by aligning with international practices [4]. Group 3: Impact on the Pharmaceutical Industry - Bi's reforms have been summarized as addressing key issues: approving generic drugs to ensure affordability, implementing consistency evaluations to guarantee efficacy, and accelerating the market entry of innovative drugs [5]. - In June 2017, China joined the International Council for Harmonisation (ICH), integrating its drug regulatory system into a globally recognized framework [5]. - The vaccine scandal in 2018 led to Bi's resignation, highlighting the challenges faced by regulatory authorities in maintaining oversight and public trust [5]. Group 4: Recognition and Awards - In December 2024, Bi Jingquan received a lifetime achievement award from the International Pharmaceutical Information Association, marking a significant recognition of his contributions to drug innovation and international collaboration [6].

Core Viewpoint - Bi Jingquan is recognized as a key figure in China's drug review reform, significantly transforming the pharmaceutical industry and facilitating the integration of Chinese innovative drugs with global standards [1][2]. Summary by Sections Background and Career - Bi Jingquan was born in September 1955 and graduated from Peking University in 1978. He has held various positions in the National Development and Reform Commission and served as the Secretary-General of the State Council before leading the drug regulatory system [2]. - He became the head of the former State Food and Drug Administration (SFDA) in January 2015, where he initiated significant reforms in the pharmaceutical sector [2]. Key Reforms - Under Bi's leadership, several reforms were implemented, including speeding up drug review and approval processes, promoting the consistency evaluation of generic drugs, and piloting the Marketing Authorization Holder (MAH) system [2][3]. - In July 2015, the SFDA announced a self-inspection and verification initiative for clinical trial data, addressing long-standing issues of data fraud [2]. - In August 2015, the State Council released opinions on reforming drug and medical device review and approval systems, marking the official start of drug review reforms [2]. Accelerated Drug Approvals - In February 2016, the SFDA issued opinions to prioritize the review and approval of drug registration applications, leading to a significant acceleration in the market entry of innovative drugs [3]. - The same month, the State Council mandated that generic drugs must demonstrate quality and efficacy consistency with original drugs [3]. - The introduction of the MAH system in June 2016 aimed to stimulate innovation among pharmaceutical developers by aligning with international practices [3]. International Integration - In June 2017, China joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), integrating its drug regulatory system into internationally recognized frameworks [3]. Challenges and Resignation - The vaccine fraud incident involving Changchun Changsheng Biotechnology in July 2018 led to significant scrutiny and the resignation of Bi Jingquan from the SFDA [4]. - Following this, he was appointed as the first Secretary of the newly established State Administration for Market Regulation, where he was initially seen as a promising leader [4]. Recognition and Awards - In August 2020, Bi was appointed as a member of the 13th National Committee of the Chinese People's Political Consultative Conference and later became the Executive Vice Chairman of the China International Economic Exchange Center [4]. - In December 2024, he received a lifetime achievement award from the International Pharmaceutical Information Association, marking a historic recognition for a Chinese individual [4].