1. Today's A-share market
Today (October 13), the broader market opened low and moved low throughout the day, and as of the close, the three major indexes closed down, and more than 3,800 stocks in the two markets fell. The Shanghai Composite Index fell 0.64% to close at 3088.10 points, the Shenzhen Component Index fell 0.99%, and the ChiNext Index fell 1.11%. The trading volume of Shanghai and Shenzhen today was 809.1 billion, basically unchanged from the previous trading day. From the perspective of the plate sector, the pharmaceutical, coal, electronics and other sectors rose slightly, while consumer services, food and beverage, power equipment and new energy fell first.
Novo Nordisk, a leading overseas diet drug, recently announced that the phase III clinical trial of semeglutide for the treatment of kidney failure and chronic kidney disease in patients with type 2 diabetes was stopped nearly a year ahead of schedule, because the interim analysis showed that the trial was successful, which represents the "panacea" known as the "panacea", and the boundary further extends to the field of chronic kidney disease. According to CCTV.com, the National Health Commission issued the "2022 Statistical Communiqué on the Development of Mainland Health Services", the data pointed out that the total amount of medical and health resources in the mainland continued to increase, and by the end of 2022, the number of medical and health institutions nationwide would reach 1032918, an increase of 1,983 over the previous year; The per capita financial subsidy standard for basic public health service projects will be raised from 79 yuan in 2021 to 84 yuan in 2022. Or stimulated by the above news, the pharmaceutical-related sector strengthened today, and the Guojin API 30 Index rose 4.37%.
2. Guojin API 30 index
The Guojin API 30 Index selects the A-shares of the API manufacturing industry, covering the API industry in the pharmaceutical manufacturing industry, and the component stocks mainly cover the A-shares of chemical APIs and key APIs pharmaceutical intermediates for the production of APIs, and after scoring and screening, the top 30 stocks are used as the index constituent stocks, and the index points are weighted by quality factors and corrected by divisors.
Third, the development of the API industry
APIs are APIs used in the production of various preparations. According to ICH Q7A (Introduction to GMP Guidelines for Active Pharmaceutical Substances), an API is defined as any substance or mixture of substances used in the manufacture of a pharmaceutical product and, when used in pharmaceutical products, becomes an active ingredient of a pharmaceutical product. From the perspective of source, APIs are divided into chemical synthetic drugs (inorganic synthetic drugs, organic synthetic drugs) and natural chemical drugs (biochemical drugs, phytochemicals).
In recent years, the number of domestic new drug applications and clinical trials has maintained growth. From a global perspective, the increasing aging trend has prompted generic drugs to replace original drugs with expired patents, thereby driving the development of the global API market. According to public information from the State Medical Products Administration, the number of new drug acceptance varieties increased from 619 in 2017 to 1,795 in 2022. The total number of clinical trials registered (announced) on the platform increased from 1,397 in 2017 to 3,320 in 2022, all showing an upward trend.
4. API industry policy
API selection and quality control were further standardized. In March 2023, the Center for Drug Review of the State Food and Drug Administration issued the "Common Issues in Pharmacy and Related Technical Requirements for the Preclinical Trial Conference of Innovative Drugs for Chemical Drugs Phase III. (Trial)", which proposes that starting materials should be reasonably selected, the rationality of the selection of starting materials should be discussed with drug evaluation agencies, and relevant supporting research materials for the selection of starting materials should be provided.
API registration requirements and acceptance review have been adjusted accordingly. In July 2023, the Center for Drug Review of the State Food and Drug Administration issued the Guidelines for the Acceptance and Review of Chemical APIs (Trial), which clearly stipulates the requirements for the registration materials of the marketing application of chemical APIs and the main points of formal review.
The mainland API industry is moving towards high-quality development. In October 2021, the National Development and Reform Commission and the Ministry of Industry and Information Technology jointly issued the Notice on the Implementation Plan for Promoting the High-quality Development of the API Industry, proposing to promote all-round and in-depth open cooperation in the API industry, participate in the global resource allocation and the division of labor in the international pharmaceutical industry at a higher level, consolidate the scale, cost and technical advantages of the API industry, cultivate well-known brands, improve quality and efficiency, and build an industrial development pattern oriented to domestic and international dual circulation.
【Guojin Securities】
Guojin Index is the company's strategic emerging business, which scientifically explores and innovates modern securities investment theory and practice, and also provides comprehensive services for index products and index strategies for corporate customers. As one of the few index institutions in China "regular army", Guojin Index builds unique strategic advantages based on Smart Beta, and has successively released a series of indexes such as stocks, bonds, overseas, funds, asset allocation, and RMB on Wind.
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Risk Warning: The content of this information is for reference only and does not constitute investment advice. The historical data of the index is not indicative of future performance, and factors such as market environment and policy changes may invalidate the analysis of the value of index investment. The market is risky, and investment needs to be cautious.