China's New Drug Development Boom: Multiple Blockbuster Medicines Set for Launch Amid Surge in R&D and IPO Filings

　　【Pharmaceutical Network Industry News】Recently, the NMPA website indicated that HEC CJ PHARM's Insulin Glargine Injection has received marketing approval. Insulin glargine is among the products included in the centralized volume-based procurement (VBP) program for insulin. Prior to this, a total of four companies had obtained approval, comprising the originator Sanofi and three domestic enterprises: Gan&Lee Pharmaceuticals, Tonghua Dongbao, and The United Laboratories. Among these, HEC CJ PHARM marks the fourth approved domestic product. Notably, on the same day, the CDE website announced that the marketing application for Hengrui's SHR-3680 tablets has been proposed for priority review, with the public notice period now underway. The drug is indicated for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) with a high tumor burden.
 

In addition, on October 22, Sihuan Pharmaceutical also announced that China's National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Anaprazole Sodium Enteric-coated Tablets. It is reported that this is the first NDA submitted by Xuanzhu Bio, a subsidiary of Sihuan Pharmaceutical.
 

Industry experts attribute the imminent launch of multiple new drugs primarily to major pharmaceutical companies ramping up R&D investment, with innovative outcomes now beginning to materialize. Data indicates that between 2018 and 2020, a total of 32 Class 1 new drugs (excluding imported drugs, new indications, and vaccines) received their initial marketing approval in China. In contrast, merely in the first half of this year, 15 Class 1 new drugs have already been approved for market launch. Furthermore, the approval and market launch of domestically produced innovative drugs have witnessed an explosive surge this year. For instance, 27 innovative drugs passed regulatory review between January and September, featuring several blockbuster drugs such as Ciprofol Injection, Aunovelin Tablets, Hetrombopag Olamine Tablets, Hyzetimibe Tablets, Savolitinib Tablets, and Disodium Levornidazole Phosphate for Injection.
 

Under the current innovation momentum, analysis indicates that as relevant authorities continue to introduce supportive policies to strengthen clinical trial data verification and accelerate the review and approval of innovative drugs, the development of China's innovative pharmaceutical industry is likely to further accelerate. It is understood that in recent years, the National Medical Products Administration (NMPA) has been actively working to expedite the approval process while continuously promoting the inclusion of new drugs into the national medical insurance system. For example, on May 17, 2018, the NMPA, in conjunction with the National Health Commission (NHC), issued the 《Announcement on Optimizing Matters Related to Drug Registration Review and Approval》, which substantially streamlined the approval procedures for new drugs already marketed overseas. Applicants are no longer required to submit applications for clinical trials and can directly apply for marketing authorization using overseas clinical trial data, effectively shortening the time to market by 1 to 2 years.
 

On September 18, 2020, in the “List of Declared Drugs Passing Formal Review for the 2020 Adjustment of the National Reimbursement Drug List” released by the National Healthcare Security Administration, 171 drugs were new drugs approved for marketing between January 1, 2015, and August 17, 2020. As early as during the 2019 adjustment of the reimbursement drug list, 70 newly marketed drugs with high clinical value in recent years had already been included in the National Reimbursement Drug List through negotiations.
 

Overall, driven by favorable national policies and sustained investment from pharmaceutical enterprises, China's new drug R&D has entered a golden age. At the same time, it is facing increasingly intense market competition. In this regard, industry experts believe that only products with genuine clinical value will be able to stand out and emerge as blockbusters in the future.
 

However, truly enhancing the R&D and innovation capabilities for Chinese-produced innovative drugs is no easy task. Beyond requiring pharmaceutical companies to continuously increase investment and pursue innovative R&D, it is imperative to vigorously cultivate pharmaceutical professionals with innovative mindsets and capabilities, refine talent development mechanisms, and formulate appropriate strategic plans. Only through these measures can an independent and controllable drug innovation system be established, thereby driving further advancement for both enterprises and the industry.