Boost Biopharma Firms to List on Suitable Domestic & Overseas Capital Markets

2024-06-16 53 Comments

Recently, Guangdong issued the "Action Plan for Further Promoting the High-Quality Development of the Guangdong Biopharmaceutical Industry." The plan aims to achieve a biopharmaceutical and health industry cluster scale exceeding one trillion yuan and a pharmaceutical industry scale above 500 billion yuan by 2027 in Guangdong Province.

The plan mentions accelerating the inclusion of eligible traditional Chinese medicine (TCM) granules into the medical insurance catalog. In accordance with national regulations, the medical insurance drug catalog of our province will be updated in a timely manner to include the medical insurance drugs announced by the National Medical Insurance Administration within the scope of our province's medical insurance fund payment. The medical insurance department will include eligible TCM formula granules and other TCM preparations in the medical insurance fund payment scope of our province during catalog adjustments, to meet the needs of insured people for TCM services.

The plan also mentions increasing financial support for the pharmaceutical industry. Implementing the 15 policies of science and technology finance, leveraging the guiding role of the National Natural Science Foundation, and promoting rapid improvement of basic research capabilities in biopharmaceuticals. Cultivating long-term investors and "patient capital," accelerating the training and formation of professional investment teams in the field of biopharmaceuticals, coordinating the use of existing policy funds such as provincial innovation and entrepreneurship funds and industrial development funds, studying the establishment of the Guangdong Biopharmaceutical Industry Investment Guidance Fund, investing in potential enterprises and high-quality R&D pipelines, and increasing investment in the upstream and downstream of the pharmaceutical industry chain. Guide financial institutions to continue to increase policy-based financial support for biopharmaceutical research and development, innovation, manufacturing, and other fields, encourage venture capital institutions to "invest early and small," mobilize social forces to establish a diversified and sustainable clinical research investment mechanism through various means such as setting up public welfare funds, accepting charitable donations, and introducing venture capital. Improve the reserve resource library of listed companies in the province, and continue to promote biopharmaceutical companies to list on appropriate domestic and foreign capital market segments.

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Action Plan for Further Promoting the High-Quality Development of Guangdong Biopharmaceutical Industry

To thoroughly implement the decisions and arrangements of the Party Central Committee, the State Council, the Provincial Party Committee, and the Provincial Government, further promote the aggregation and momentum of our province's biopharmaceutical industry, and strive to achieve a biopharmaceutical and health industry cluster scale exceeding one trillion yuan and a pharmaceutical industry scale above 500 billion yuan by 2027, this plan is formulated to help our province build a strong biopharmaceutical province with high quality.

1. Improve the industry development collaboration mechanism. Under the overall guidance of the "chain leader" of the biopharmaceutical and health industry cluster, improve the efficient collaboration mechanism for promoting the high-quality development of the biopharmaceutical industry across departments and key regions, deepen the "three medical collaborations," and strengthen the overall coordination of research and development, approval, production, operation, application, and supervision links. Regularly hold policy communication dialogues between the government and enterprises in the pharmaceutical industry, strengthen policy publicity, unblock communication channels, and discuss industrial development together.

2. Increase support for the entire chain of innovative drugs and medical devices.有条件的地市对创新药械临床前研究、临床试验、审批获证、产业化落地、推广应用等全链条各环节予以政策、资金等支持。统筹省科技创新战略、产业创新能力建设、产业基础再造等专项资金,谋划布局"高端医疗器械""生物医药与健康""岭南中医药现代化及关键技术装备""精密仪器设备"等新一轮省重点领域研发计划专项,支持创新药、中药标准化规范化、高端医疗器械、高端科学仪器和试剂、智能生产设备领域开展关键核心技术攻关和标志性产品产业化攻坚。发布我省已获批生物医药创新药械产品目录,并按照"应配尽配"原则,推动加快入院应用。

3. Accelerate the construction of innovation platforms and infrastructure. Strengthen the construction of major innovation platforms such as Guangzhou Laboratory, Bio Island Laboratory, Shenzhen Bay Laboratory, Shenzhen Advanced Institute of the Chinese Academy of Sciences, Guangdong Biopharmaceutical Science and Technology Innovation and Transformation Center, Zhongshan Institute of Drug Innovation of the Chinese Academy of Sciences, Biomacromolecule Pilot Base, South China Biopharmaceutical Large Animal Model Research Institute, and South China Biosafety Level 4 Laboratory, to accelerate the transformation of scientific research results in our province. Continue to promote the construction of a number of major scientific and technological infrastructure such as the second phase of the National Gene Bank and the Human Cell Line Device, and actively strive for the "Human Protein Navigation" international large-scale science project to settle in Guangzhou. Support the Guangzhou Laboratory and the China Food and Drug Inspection and Research Institute to build a joint laboratory in the Shenzhen River Set, promote the construction of national drug administration key laboratories, Guangdong Biopharmaceutical Science and Technology Collaborative Innovation Center, medical device reliability and usability laboratories, and frontier medical device product quality and safety evaluation laboratories such as medical robot laboratories.

4. Promote the construction of R&D service platforms. The province and cities will work together to introduce and cultivate a number of service platforms such as CRO (Contract Research Organization), CMO (Contract Manufacturing Organization), CDMO (Contract Development and Manufacturing Organization), CTDMO (Contract Testing, Development, and Manufacturing Organization), concept validation centers, and pilot platforms, and有条件的地市予以资金支持。着力提升药品和医疗器械研发、临床前研究、临床试验等研发服务水平。Twenty-five, Accelerate the layout of new fields and new tracks. Strengthen the exploration of multiple paths of frontier technologies and the supply of disruptive technologies, focusing on the development of new fields and new tracks such as gene technology, cell therapy, AI+biomedicine, synthetic biology, brain science and brain-like research. Fully utilize generative artificial intelligence, deep learning and other technologies to carry out multi-field analysis and research on new drug design and screening, recombinant antibody design and synthesis, new drug delivery materials or delivery systems. Develop biomanufacturing models such as chemical drugs and intermediates, natural drugs, functional components of Chinese herbal medicines, and pharmaceutical excipients.

Twenty-six, Promote the steady development of generic drugs. Give play to the role of the drug patent linkage system, and under the premise of protecting the legitimate rights and interests of drug patent owners, support enterprises to start the development and registration application of generic drugs as soon as possible during a reasonable period before the expiration of the original drug patent, accelerate the listing process of generic drugs, and meet the needs of the public for medication. Encourage cities with conditions to support high-end generic drugs, first generic drugs, and difficult-to-imitate drugs. Continue to promote the consistency evaluation of the quality and efficacy of generic drugs, strengthen inter-departmental collaboration, and guide and instruct the whole process of policy guidance and business guidance to continuously improve the quantity and quality of varieties in our province that have passed the consistency evaluation.

Twenty-seven, Strengthen the introduction and gradient cultivation of key pharmaceutical companies. The province and cities jointly formulate enterprise investment intention conditions, increase efforts to introduce leading enterprises, high-end research and development institutions, and major industrial projects in the fields of biomedicine and biomanufacturing at home and abroad. Continue to increase support for technology-based small and micro enterprises, and cultivate a group of high-tech enterprises and specialized and sophisticated enterprises in the sub-tracks of the future life and health industry. By 2027, at least 15 enterprises at the level of tens of billions will be cultivated and developed, forming a group of specialized and sophisticated, "unicorn" and single-champion enterprises in various fields, and promoting well-known domestic and foreign pharmaceutical companies to layout regional sub-centers in our province.

Twenty-eight, Support digital transformation to improve production efficiency. Support biopharmaceutical industrial enterprises to carry out digital transformation throughout the entire life cycle of R&D, quality, production, testing, marketing, compliance, etc., and promote the digital transformation of sub-fields such as chemical drugs, biological drugs, traditional Chinese medicine, and medical devices according to industry characteristics. For eligible technical transformation projects, the new equipment purchase amount will be rewarded at a ratio of no more than 20% in the Pearl River Delta region and no more than 30% in the eastern, western, and northern Guangdong regions (Huizhou Huidong County, Boluo County, Longmen County, Jiangmen Taishan City, Kaiping City, Heshan City, Enping City, Zhaoqing Sihui City, Guangning County, Deqing County, Fengkai County, Huaiji County will implement the support policy of the eastern, western, and northern Guangdong regions), and the reward amount for a single supported project will not exceed 15 million yuan.

Twenty-nine, Build biopharmaceutical industrial parks. Promote the development of biopharmaceutical industry gathering areas such as Guangzhou International Bio Island, Guangzhou Science City Bio-industry Base, Sino-Singapore (Guangzhou) Knowledge City Life and Health Industry Base, Nansha "One City, Three Valleys, Six Parks", Shenzhen Pingshan National Bio-industry Base, Shenzhen Nanshan Biomedicine Industrial Park, Zhuhai Jinwan Biopharmaceutical Industrial Park, Hengqin Guangdong-Macao Cooperation Traditional Chinese Medicine Science and Technology Industrial Park, Zhongshan National Health Science and Technology Industry Base, Foshan Yunhai Sea Pharmaceutical Health Industrial Park, Dongguan Songshan Lake Bio Base, etc., to form more than 10 biopharmaceutical industrial parks with distinct characteristics, significant scale benefits, and obvious radiation and driving effects.

Thirty, Continue to promote the innovative development of drug and medical device regulation in the Guangdong-Hong Kong-Macao Greater Bay Area. Fully utilize the "Hong Kong and Macao Medicine and Device Pass" policy, accelerate the expansion of designated medical institutions and product scope, and explore the gradual expansion of the applicable area. For Hong Kong and Macao medicines and devices that are urgently needed in clinical practice and have been marketed, optimize the approval process and accelerate clinical use. The review period for traditional external Chinese patent medicines marketed in Hong Kong and Macao will be reduced from 200 working days to 80 working days, and the approval period for post-marketing changes and re-registration will be reduced by 50 working days, respectively, to accelerate the market access of Hong Kong and Macao external Chinese patent medicines in the mainland market. Promote the reform of drug marketing permit holders and medical device registrants in the Greater Bay Area, support the nine mainland cities of the Greater Bay Area to connect with the Hong Kong and Macao biopharmaceutical industry, and promote the formation of a complementary and interactive pharmaceutical industry chain between Guangdong, Hong Kong, and Macao.

Thirty-one, Optimize the import filing mechanism for drugs and biopharmaceutical research items. Optimize the import filing process for multiple imports of the same drug and non-first-time imported drugs, support port drug supervision and management departments to simplify the material verification and declaration process for import units with large import business volume and good credit records, and improve the work efficiency of drug import filing. Support biopharmaceutical industry gathering areas such as Guangzhou Huangpu District and Nansha Free Trade Zone to establish a "white list" system for the import of biopharmaceutical research items, and items included in the "white list" do not need to provide an "import drug customs declaration form" when importing, to accelerate the research and development process of innovative drugs.

Thirty-two, Support biopharmaceutical companies to expand the international market. Support domestic biopharmaceutical companies to explore the European and American markets and seize emerging markets such as ASEAN, Africa, and South America through key exhibitions such as the Canton Fair and "Guangdong Trade Global". Innovate the "medicine and device led by medicine" model to fully enhance the radiation and influence of Guangdong's biopharmaceutical industry. Build and improve the "going global" public service platform to provide public services such as country policies, laws and regulations, tax policies, and intellectual property rights for biopharmaceutical companies, guide companies to strengthen overseas compliance operations and risk prevention, and promote biopharmaceutical companies to go global steadily to carry out overseas mergers and acquisitions. Support biopharmaceutical companies to carry out international multi-center clinical trials and synchronous registration and listing.

Thirty-three, Increase financial support for the pharmaceutical industry. Implement the 15 policies of science and technology finance, give play to the guiding role of the National Natural Science Foundation, and promote the rapid improvement of basic research capabilities in biomedicine. Cultivate medium and long-term investors and "patient capital", accelerate the cultivation and formation of specialized investment teams in the field of biomedicine, make good use of existing policy funds such as provincial innovation and entrepreneurship funds and industrial development funds, study the establishment of the Guangdong Biomedicine Industry Investment Guidance Fund, invest in potential enterprises and high-quality R&D pipelines, and increase investment in the upstream and downstream of the pharmaceutical industry chain. Guide financial institutions to continue to increase policy financial support for fields such as biopharmaceutical research and development, innovation, and manufacturing, encourage venture capital institutions to "invest early and small", mobilize social forces to establish a diversified and sustainable clinical research investment mechanism through various means such as setting up public welfare funds, accepting charitable donations, and introducing venture capital. Improve the reserve resource library of listed companies in the province, and continue to promote biopharmaceutical companies to go public on suitable domestic and foreign capital market segments.

Thirty-four, Promote the development of commercial health insurance. Promote the strengthening of data connection and cooperation between medical institutions and commercial insurance companies, and optimize the "one-stop" settlement of basic medical insurance, serious disease insurance, and medical assistance. Support commercial insurance companies to develop inclusive commercial health insurance products and services that cover innovative drugs and devices, and support the purchase of inclusive commercial health insurance with individual accounts of employee medical insurance.Thirty-five, Promote the development of "Internet+ Medical Health". Actively promote eligible medical insurance designated medical institutions to carry out Internet medical services, include the "Internet+" medical service prices into the current medical service price policy system for unified management, and include eligible "Internet+" follow-up medical services into the scope of medical insurance fund payment. In principle, implement unified management for online and offline medical services, and improve agreement management, settlement processes, and related indicators based on service characteristics.

Thirty-six, Steadily advance the sharing and application of medical data. Support the construction of a medical health big data platform and the Guangdong-Hong Kong-Macao Greater Bay Area node of the national biodata center system by Guangzhou Laboratory. Establish and improve the data resource system and data exchange sharing mechanism for the entire chain of biomedicine. Research and carry out pilot operations of public data. In accordance with the requirements of national laws, regulations, and rules, explore and implement a "white list" system for cross-border data circulation. Achieve secure and orderly cross-border data flow for biopharmaceutical companies through models such as including data authorization cross-border catalogs and data subject authorization. Explore the construction of a normalized scientific research data review system, and support the orderly cross-border flow of application research and medical data resources needed for scientific cooperation projects within the Greater Bay Area. Support the use of big data technology for collaborative innovation in medical services and innovation in clinical and research applications.

Thirty-seven, Carry out pharmaceutical and medical device promotion and introduction. Actively undertake large-scale events such as the China Bioindustry Conference, China Pharmaceutical Industry Information Annual Conference, and the release conference of the China Pharmaceutical Industry Top 100 List. Conduct irregular, regional "Hundreds of Enterprises and Hundreds of Hospitals in Guangdong Medical Practice" activities, carry out the release and promotion of new medical devices and key products, and promote the industrial application of medical devices and the promotion and application of new drugs.

Thirty-eight, Strengthen the construction of pharmaceutical innovation talent teams. Gather high-level scientific research, production, marketing, and service talents from home and abroad to build and improve a biomedicine expert think tank. Give full play to the linkage and superposition effects of national, provincial, and municipal talent projects. Relying on major innovation platforms and colleges and universities, introduce a group of urgently needed and short strategic scientific and technological talents, scientific and technological leaders, young scientific and technological talents, and high-level innovation teams for the development of the biopharmaceutical industry, and introduce top talents such as Nobel Prize winners and domestic and foreign academicians to work in Guangdong on a "one case, one discussion" basis. Strengthen the cultivation of talents in the field of biomedicine, focus on the needs of industrial development, optimize the professional structure of colleges and universities, and continue to cultivate a group of biomedicine fields with strong domestic influence.

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