Chongqing's Surge in Biopharmaceutical Innovation: Building a New Industry High Ground

(Source:China MedicineReport)

Source: China Pharmaceutical News

□ Reporter Li Yizhen from this newspaper

During the "14th Five-Year Plan" period, Chongqing City added 168 pharmaceutical, medical device, and cosmetics manufacturing enterprises, driving the increase of over 20,000 business entities; 4,710 new medical device products were approved for marketing with an average annual growth rate of 15%; 299 new drugs were approved for marketing with an average annual growth rate of 82%, achieving a breakthrough from "zero" in innovative drugs. The momentum of biopharmaceutical innovation continues to improve, and the innovation ecosystem is rapidly taking shape.

——This is the data recently announced by Chen Dilong, Party Secretary and Director of the Chongqing Municipal Medical Products Administration, at the 23rd press conference of the series of themed press conferences on "High-Quality Completion of the '14th Five-Year Plan' and Writing a Chongqing Chapter of Chinese-Style Modernization" held by the Chongqing Municipal Government Information Office.

Chongqing, the vibrant city built along the mountains and surrounded by two rivers, is rapidly advancing towards new heights in the biopharmaceutical industry.

Cultivating Soil and Strengthening Roots: Building an Innovative Ecosystem for Yufeng Pharmaceuticals

Chongqing has a solid foundation in the pharmaceuticals industry. However, a survey conducted by the Chongqing Municipal Medical Products Administration revealed that although local universities and research institutes have achieved numerous research results, issues such as isolated R&D information, and the disconnection between R&D and commercialization due to a lack of effective communication with enterprises, have to some extent restricted the innovative development of the industry.

To solve this problem, the Chongqing Municipal Medical Products Administration took the initiative to play a coordinating role and led the launch of the "Chongqing Pharmaceutical Innovation Ecosystem" construction in January last year. This project integrates the dispersed innovative policies, project funds, and technical talent resources of government departments, scientific research institutes, medical institutions, and key universities, establishing an efficient docking and resource-sharing biomedicine "government-industry-academia-research-application" exchange and cooperation platform, promoting the innovative development and achievement transformation of the biomedicine industry.

The Innovation Ecosystem Chain of YU Medicine is divided into five professional working groups: Traditional Chinese Medicine, Chemical Medicine/Cosmetics, Biopharmaceuticals, Medical Devices, and In Vitro Diagnostic Reagents. Each working group is equipped with a reviewer from the technical evaluation department to provide enterprises with pre-research and development project initiation to registration submission technical consultation.

To strengthen technical support, the Chongqing drug regulatory department has actively "introduced intelligence to Chongqing," inviting experts from the National Medical Products Administration and related technical departments to Chongqing multiple times. They provide policy interpretation and training for member units of the Chongqing pharmaceutical innovation ecosystem. At the same time, they guide each working group to regularly hold academic salons and project matchmaking meetings to promote the efficient flow of innovative resources.

Under the facilitation of Chongqing's pharmaceutical regulatory authorities and the efforts of all parties, the deep integration of industry, academia, and research has accelerated the emergence of achievements. Chongqing Precision Biotech Co., Ltd. (hereinafter referred to as Precision Biotech) has engaged in in-depth cooperation with multiple universities such as Chongqing University and Southwest University, and its product clinical trials have been simultaneously carried out in several medical institutions within the group. With the support from all sides, the CAR-T product Pujiaolun Injection independently developed by Precision Biotech was approved for marketing on November 4, becoming the second innovative biologic product approved in Chongqing in recent years.

"Puji Oronos Injection is the first CAR-T product in China and the second globally for the treatment of childhood leukemia," said Fan Wei, Director of the Chongqing Center for Drug Evaluation and Inspection. "This is not only the approval and market launch of a product, but also a reflection of the achievements of Chongqing's innovative ecosystem."

As of mid-October this year, the Yu Medicine Innovation Ecosystem has attracted 157 companies to join, provided targeted support for 174 drug R&D projects, and facilitated substantial progress in 66 projects, among which 36 products have been submitted for market approval, with 18 products already approved for marketing.

Warm-hearted Escort: Providing Precise Services for Enterprises

Walking into the first-floor hall of the Chongqing Municipal Drug Administration, the thank-you letters from enterprises posted on the bulletin board vividly witness the profound transformation of the administration's regulatory model from "enterprises seeking departments" to "departments actively reaching out to enterprises."

To enhance service efficiency, the Chongqing Municipal Medical Products Administration has extended its technical service window to the "doorstep" of enterprises. In collaboration with key district and county governments, the administration has established five biopharmaceutical innovation service centers within biomedicine industrial parks. These centers provide enterprises with policy interpretation, technical support, and risk alerts, fully accelerating the fast track for innovative drugs and medical devices from laboratory to market approval.

Chongqing Zhongyuan Huiji Biotechnology Co., Ltd. has deeply felt the speed of this fast track. In 2023, its human mucin-resistant protein A test kit product entered the Chongqing Municipal Medical Products Administration’s innovative approval channel. The Chongqing Center for Drug Evaluation and Inspection quickly arranged a dedicated team to provide pre-technical evaluation services, organized expert discussions on clinical protocols twice, and conducted preliminary assessments on key issues such as sample enrollment to reduce clinical supplements. After the product registration application was accepted, the Chongqing Center for Drug Evaluation and Inspection adopted a combined model of group review, collective decision-making, and expert evaluation for technical assessment, while simultaneously initiating the product registration quality system verification and clinical authenticity verification, rapidly completing the technical evaluation and accelerating the product's market entry.

While helping companies seize the domestic market in China, the Chongqing Municipal Medical Products Administration also regularly organizes medical device export policy exchange salons to assist companies in understanding international rules and expanding export channels. After attending the medical device export policy exchange salon hosted by the Chongqing Municipal Medical Products Administration, Zou Xiaojun, the head of Chongqing Zhengren Medical Device Co., Ltd., stated: "Through the salon discussions, we have gained a deeper understanding of European registration regulations, which will greatly help us expand into overseas markets."

While providing proactive services, the Chongqing Municipal Medical Products Administration (MPA) has also been helping enterprises reduce their burdens. During the "14th Five-Year Plan" period, the Chongqing MPA has vigorously promoted administrative approval reform centered on the "Four Reductions." As of mid-October this year, through "reducing steps," the bureau optimized internal approval processes and established a tiered classification approval system for production and operation, cutting 153 processing steps, approving 37,677 cases with reduced steps, and handling 101 concurrent approvals. Focusing on "reducing materials," it streamlined material lists by integrating and sharing information, allowing some materials to be exempt from submission, reducing 204 application documents. Regarding "reducing timeframes," it compressed the promised processing time for all government service items to 50% of the statutory timeframe. Based on "reducing trips," 131 government service items have been made available for "full online processing." These reform measures have significantly enhanced enterprises' sense of gain and satisfaction.

Multi-pronged Approach to Stimulate Industrial Innovation Vitality

Innovation is the core engine leading the high-quality development of the pharmaceutical industry and the vital source safeguarding public health. The Chongqing Municipal Medical Products Administration has adopted multiple measures to stimulate corporate innovation vitality, injecting continuous momentum into the industry's high-quality development.

August 20th last year, ChongqingZhi Xiang Jin TaiChongqing ZhiXiang Jintai Biopharmaceutical Co., Ltd. (hereinafter referred to as ZhiXiang Jintai) has received approval for the market launch of its innovative Class 1 drug, Selicibart Injection, marking a "zero" breakthrough in Chongqing's innovative drug sector.

Zhi Xiang Jin Tai's Vice General Manager Dai Li expressed deep emotion: "At that time, we were not familiar with the registration process. The Chongqing Municipal Drug Administration's regulatory staff proactively visited us, pre-reviewed the application materials, and provided guidance. They also coordinated with the evaluation department to conduct a pre-inspection of our production quality management system, providing strong support for the rapid market entry of the product."

Nowadays, efficient review and approval have become a key measure for the Chongqing Municipal Medical Products Administration to promote the high-quality development of the pharmaceuticals industry.

In November last year, Chongqing became one of the first pilot provinces in China to optimize the review and approval process for drug supplements, providing pre-submission guidance, inspection, testing, and dossier preparation services for major change supplements applied by Marketing Authorization Holders (MAHs) or Active Pharmaceutical Ingredient (API) registrants within Chongqing. The Chongqing Municipal Medical Products Administration quickly established a special working group, strengthened capacity building to align with the pre-submission services, and simultaneously developed various management systems that match the reform requirements, ensuring the smooth progress of the pilot program.

As of October 10 this year, the Chongqing Municipal Medical Products Administration has received a total of 26 supplementary drug applications for preliminary services, and efficiently completed 20 of them. Among these, 11 have been accepted by the Center for Drug Evaluation of the National Medical Products Administration after preliminary services, and eight have been approved. The approval time has been shortened from 200 working days to as few as 26 working days, significantly improving the efficiency of the review and approval process for supplementary drug applications.

In September this year, another重磅消息传来: the Southwest Branch of the National Medical Products Administration's Center for Drug and Medical Device Review and Inspection has been established in Chongqing. This means that Chongqing's pharmaceutical innovation enterprises can enjoy high-level national technical review and pre-inspection services "at their doorstep."

In addition, the Chongqing Municipal Medical Products Administration also actively supportsInnovative HealthcareDevelopment of Medical Devices. The bureau, in collaboration with relevant departments, has established a key cultivation project database for intelligent medical equipment. An online "research and report at any time" window has been opened to proactively collect ongoing projects with strong innovation, high clinical value, and promising market prospects. These projects are supported by designated personnel who provide tailored services, integrating research and review processes while extending technical support to the forefront of product innovation and development. According to reports, out of the 286 projects initially selected, 50 products had completed registration as of mid-October this year.

Under the relentless efforts of the Chongqing Municipal Medical Products Administration, the biopharmaceutical industry in Chongqing is flourishing. In the future, the administration will continue to uphold its service-oriented philosophy, optimize the innovation ecosystem, and help propel Chongqing's biopharmaceutical industry to a higher level.