China's Innovative Drug Sector Flourishes as a Wave of Pharmaceutical Companies Enters the Harvest Phase

　　【Pharmaceutical Network Market Analysis] Recently, the NMPA website showed that Qilu Pharmaceutical's Aripiprazole Oral Soluble Film and Memantine Hydrochloride Oral Soluble Film have been approved for marketing, both being the first of their kind in China. Among them, Aripiprazole is a new type of atypical antipsychotic frontline medication, mainly producing therapeutic effects by acting on dopamine receptors and serotonin receptors. It is the first dopamine partial receptor agonist used clinically, primarily for the treatment of schizophrenia. Compared with other psychiatric treatment drugs, Aripiprazole has the advantages of fewer side effects, significant efficacy, and low recurrence rate.
 

Memantine hydrochloride is a first-line treatment for moderate to severe Alzheimer's disease recommended by the U.S. "Guidelines for the Use of Medications by Experts" and can be used alone or in combination with donepezil or rivastigmine. Currently available formulations in China include tablets, oral solutions, and extended-release capsules.
 

Notably, since the beginning of this year, Qilu Pharmaceutical's product line has seen continuous good news, with 8 varieties approved for marketing and a cumulative total of 105 products passing evaluations. According to reports, on June 21, the NMPA website showed that Qilu Pharmaceutical’s Carboplatin Injection passed the consistency evaluation, becoming the first in China to do so.
 

Platinum-based antitumor drugs are an important part of Qilu Pharmaceutical's oncology portfolio. Currently, Qilu Pharmaceutical has a range of platinum products from the first to third generations, including Cisplatin Injection, Carboplatin Injection, Nedaplatin for Injection, and Oxaliplatin Injection. Moreover, four of its platinum injectables have passed/been deemed to pass the consistency evaluation.
 

In addition to Qilu Pharmaceutical, several other pharmaceutical companies have recently received approval for their products' market applications, including the TQ-B3101 capsule by Zhengda Tianqing and the SHR-A2102 injection by Hengrui Medicine. Among them, multiple companies have already had several new drugs approved. For example, just recently, JMT103 "Naleshuzumab Injection," a Class 1 new drug from Jinmante, a subsidiary of CSPC Pharmaceutical Group, has also been submitted for marketing approval and accepted. The Center for Drug Evaluation has agreed to grant priority review, and the application is currently in progress. The indication for this application is the treatment of unresectable or surgically challenging giant cell tumors of the bone. JMT103 is a next-generation innovative fully human anti-RANKL (IgG4) monoclonal antibody that can inhibit bone resorption mediated by multinucleated osteoclasts by blocking the formation of these cells.
 

Currently, CSPC Pharmaceutical Group has 80 innovative drugs under development globally. Among them, 6 have been approved for marketing, and 4 are in the process of registration, including JMT103, Irinotecan Liposome, Rizetinib, and Lipusu Monoclonal Antibody.
 

In addition, Hengrui Medicine's announcement on May 25 showed that its subsidiary, Shandong Shengdi Pharmaceutical Co., Ltd., received the "Drug Registration Certificate" issued by the National Medical Products Administration for its Ambroxol Hydrochloride Oral Solution. At the beginning of 2022, Hengrui Medicine also launched or submitted for marketing authorization four innovative drugs. Among them was the marketing application for SHR-1316 (Adebrelimab Injection), a Class 1 new drug and PD-L1 monoclonal antibody, in combination with chemotherapy as first-line treatment for extensive-stage small cell lung cancer.
 

Overall, benefiting from strong market demand and substantial policy support, China's innovative drug industry is thriving. The industry generally believes that the development of innovative drugs will continue to gain momentum. Meanwhile, as innovative drug companies increase their R&D investment, the clinical pipeline layout is becoming increasingly enriched, and more new drugs are expected to come to market successively, benefiting a wide range of patients.
 

Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.