Original Katsura Rice Intranet
Highlights
Recently, Kangyuan Pharmaceutical Longqi Capsule applied for NDA, Fangsheng Pharmaceutical Yiqi Xiaomao Granules applied for IND, and Suzhong Pharmaceutical Hemorrhoidal Fistula Fumigation Granules was approved for clinical ...... Since the beginning of this year, 5 new Chinese medicine drugs have been approved for marketing in China, hitting a record high in the same period, 11 new Chinese medicine drugs have been reported for production, and the number has increased significantly, and 18 new Chinese medicine drugs have been declared IND, and the research and development in the fields of respiratory, gynecology and digestion is hot. During the performance disclosure period of listed companies, the net profit of many traditional Chinese medicine companies has increased significantly, and R&D investment has increased.
5 new traditional Chinese medicine drugs have been approved for marketing! Qijin, Zhuohe, and Chengdu Huaxi are on the list
In the first quarter of 2024, the State Food and Drug Administration approved a total of 5 new TCM drugs for marketing. Among them, there are 3 innovative drugs in category 1.1 of traditional Chinese medicine, including catechu supernatant pills of Hubei Qijin Pharmaceutical Co., Ltd., Jiuwei cough suppressant oral liquid of Zhuohe Pharmaceutical Co., Ltd., and Qinwei granules of Chengdu Huaxi Natural Medicine, and 2 new drugs of category 3.1 of traditional Chinese medicine (i.e., compound preparations of traditional Chinese medicine with ancient classic prescriptions), including peony licorice decoction granules from Wuhan Kangle Pharmaceutical Co., Ltd. and Linggui Shugan granules from China Resources Sanjiu.
New Chinese medicine drugs approved for marketing in China in the first quarter of 2024
Source: Minenet China Declaration Progress (MED) database
New Chinese medicine drugs have entered the harvest period, and the number of approvals in the first quarter of 2024 has reached a record high in the same period. In the past 2023, a total of 9 new Chinese medicine drugs have been approved for marketing in China, but the first new Chinese medicine drug was approved for marketing on 8 June 2023. In the first quarter of 2022, the State Food and Drug Administration only approved the marketing of Beijing Shennuoji's icariin soft capsules. In the first quarter of 2021, the State Food and Drug Administration approved the listing of the anti-epidemic "tripartite" new drugs Qinglung Detoxification Granules, Dampness Sepsis Granules, and Xuanlung Sepsis Granules.
Hubei Qijin Pharmaceutical Co., Ltd.'s catechu Shangqing pill, also known as "Jingmen Shangqing Pill", originated in the late Ming and early Qing dynasties, and has been circulating for more than 400 years. The drug has the effects of clearing heat and annealing, detoxifying sores and relieving pain, and is used for mild recurrent aphthous ulcers. According to data from Minenet, in 2022, the sales of Chinese patent medicines for mouth ulcers in China's three major terminals and six major markets (see the statistical scope at the end of this article for details) will exceed 600 million yuan. Catechu Supernatant Pill is the first national Class 1 new drug approved in Jingmen City, and it is also the first Class 1.1 innovative drug of oral ulcer Chinese medicine in China.
Jiuwei Cough Suppressant Oral Liquid is derived from Professor Zou Xuexi's clinical experience prescription, which has the effect of promoting lung and relieving cough, and is used for the treatment of acute bronchitis wind-heat cough syndrome, and the prescription is composed of dwarf tea, loquat leaves, ephedra, bitter almonds, peppermint, tangerine peel, bamboo ru, Houttuynia cordata and boiled licorice. The drug is researched and developed by Suzhou Yusen New Medicine, and Zhuohe Pharmaceutical is responsible for marketing and sales, and the two parties share the profits after the product is launched. According to data from Minenet, in 2022, the sales of cough, expectorant and asthma Chinese patent medicines in China's three major terminal and six major markets will exceed 24 billion yuan.
Chengdu Huaxi Natural Medicine's Qinwei Granules (formerly known as: Pain and Wind Granules) are composed of Qin bark, clematis, angelica and Chuanxiong, which have the effects of clearing heat, removing dampness and dispelling wind, invigorating blood circulation and relieving pain, and are used for the treatment of acute gouty arthritis rheumatism and depression. According to data from Minenet, in 2022, the sales of Chinese patent medicines for rheumatic diseases in China's three major terminal markets exceeded 11.5 billion yuan. At present, two types of gout Chinese medicine Class 1.1 innovative drugs in China, Huzhen Qingfeng Capsule and Qinwei Granules, have been approved for marketing.
11 new traditional Chinese medicine drugs are reported for production!Kangyuan, Yuekang, and Tasly are eyeing the 400 billion market
On April 4, Kangyuan Pharmaceutical's marketing application for Longqi Capsule, a class 1.1 innovative drug of traditional Chinese medicine, was undertaken. The drug is a traditional Chinese medicine compound preparation composed of ten flavors of Chinese herbal medicines such as Panax notoginseng, which has the effect of removing phlegm and removing stasis, clearing the lungs and eliminating accumulation, and is used for the treatment of lung cancer, and is expected to become the first anti-tumor Chinese medicine innovative drug in China.
In recent years, there has been a surge in the research and development of new Chinese medicine drugs in China, with a total of 10 new Chinese medicine drug marketing applications being undertaken in 2022 and 23 new Chinese medicine drugs in 2023. In the first quarter of 2024, 10 new Chinese medicine drug marketing applications were undertaken, an increase of more than 66% compared with the first quarter of 2023 (6 drugs).
2024-present marketing status of new Chinese medicine drugs
There are 6 Class 1.1 innovative drugs of traditional Chinese medicine, including Yuekang Pharmaceutical's Tongluo Jiannao Tablets and Zihua Wenlung Cough Granules, Jianmin Group's Niuhuang Pediatric Antipyretic Patch, Kangyuan Pharmaceutical's Longqi Capsules, Dongfang Yunjia's Pediatric Gold Cough Granules, and Ruihe Pharmaceutical's Throat Clearing Capsules. Among them, there are 2 pediatric drugs, and data from Minenet shows that in 2022, the sales of pediatric proprietary Chinese medicines in China's three major terminal markets will exceed 16 billion yuan.
There are 5 new drugs in category 3.1 of traditional Chinese medicine, including Tasly's Loquat Qinglung Drink Granules and Wenjing Tang Granules, Zhongjing Wanxi Pharmaceutical's Loquat Qinglung Granules, Jilin Aodong's Consistent Decoction Granules, and Yaodu Zhangshu's Erdong Granules. Among them, 2 drugs for digestive system diseases and 2 drugs for respiratory diseases, and 1 drug for gynecology. At present, 20 new drugs of 3.1 class of traditional Chinese medicine have applied for NDA in China, mainly focusing on gynecological drugs (7) and respiratory diseases (6).
According to data from Minenet, the sales of proprietary Chinese medicines in China's three major terminal markets will be close to 400 billion yuan in 2022, a year-on-year increase of more than 5%. In terms of therapeutic areas, Chinese patent medicines for cardiovascular and cerebrovascular diseases led the way with sales of more than 96 billion yuan, the second ranked respiratory diseases with sales of more than 80 billion yuan, and Chinese patent medicines for digestive diseases ranked third with sales of nearly 42 billion yuan.
Sales of proprietary Chinese medicines in China's three major terminal markets (unit: 10,000 yuan)
Source: Minenet Grid Bureau Database
Since the implementation of the new version of the registration classification of traditional Chinese medicines in 2020, no Class 1 innovative drugs of traditional Chinese medicine for cardiovascular and cerebrovascular diseases have been approved for marketing in China. At present, only Yuekang Pharmaceutical's TCM Class 1.1 innovative drug Tongluo Jian Brain Tablets and TCM Class 1.2 innovative drug Hydroxysafflower Yellow Pigment A for injection are under review, and it is expected that the company will win the first Class 1 innovative drug of TCM for cardiovascular and cerebrovascular diseases in China.
18 new traditional Chinese medicine drugs have applied for IND, and the research and development of traditional Chinese medicine enterprises has increased
Entering April, the IND applications of 3 new Chinese medicine drugs ushered in progress. On the 7th, Fangsheng Rongda's clinical trial application for the 1.1 class of traditional Chinese medicine innovative drug Yiqi Xiaomao Granules for the treatment of uterine fibroids was undertaken; on the 4th, the clinical trial application of the 2.3 class of traditional Chinese medicine improved new drug Danhong Huayu Oral Liquid of Baiyunshan Hutchison Whampoa was undertaken, and the new indications are planned; on the 2nd, the clinical trial application of the 1.1 class innovative drug Si Yadan gel of the Xinjiang Institute of Physics and Chemistry of the Chinese Academy of Sciences was undertaken, for the treatment of vitiligo.
As of April 9, 18 clinical trial applications for new Chinese medicine drugs have been undertaken in China, and a number of innovative drugs focus on respiratory, gynecology and digestion. Among them, there are 13 Class 1 innovative drugs of traditional Chinese medicine and 5 Class 2 improved new drugs of traditional Chinese medicine, involving well-known traditional Chinese medicine companies such as Kangyuan Pharmaceutical, Lei Yunshang, Suzhong Pharmaceutical, Baiyunshan Hutchison Whampoa, Fangsheng Pharmaceutical, etc.
Clinical application of new Chinese medicine drugs from 2024 to the present
Among the 18 new traditional Chinese medicines, Jiangsu Zhongyong Hongrui's traditional Chinese medicine class 1.1 innovative drug Xiangshu Pinggassan (for the treatment of chronic non-atrophic gastritis spleen and stomach deficiency and cold syndrome), Suzhong Pharmaceutical Co., Ltd.'s traditional Chinese medicine class 1.1 innovative drug hemorrhoidal fistula fumigation granules (for the improvement of mixed hemorrhoids after surgery), Xinqikang Pharmaceutical's 2.3 class of traditional Chinese medicine improved new drug Xipayigu gingival liquid (for radiation oral mucositis), Kangyuan Pharmaceutical's traditional Chinese medicine class 1.1 innovative drug Qiangqin granules (for the treatment of influenza), Guangzhou University of Chinese Medicine's Class 1.1 innovative Chinese medicine drug Qingxing Granules (for the treatment of common cold) has been approved for clinical use.
The promotion of the R&D of new Chinese medicine drugs is inseparable from the heavy investment of enterprises, and the growth of performance can provide strong support for the R&D investment of enterprises. During the disclosure period of the annual reports of listed companies, the performance of many traditional Chinese medicine companies came with good news. As of April 9, 23 traditional Chinese medicine companies have disclosed their 2023 annual reports, of which 15 companies' net profits have increased by more than 10%, and 11 companies' R&D expenses have increased by more than 10%.
Kangyuan Pharmaceutical's net profit in 2023 will be 537 million yuan, a year-on-year increase of 23.54%, and R&D expenses will be 772 million yuan, a year-on-year increase of 27.40%.
In 2023, CR Sanjiu's net profit will be 2.853 billion yuan, a year-on-year increase of 16.50%, and its R&D expenses will be 715 million yuan, a year-on-year increase of 20.30%.
Tongrentang's net profit in 2023 will be 1.669 billion yuan, a year-on-year increase of 16.92%, and its R&D expenses will be 280 million yuan, a year-on-year increase of 28.68%.
Taiji Group's net profit in 2023 will be 822 million yuan, a year-on-year increase of 131.99%, and its R&D expenses will be 234 million yuan, a year-on-year increase of 113.52%.
In 2023, the net profit of Darentang will be 987 million yuan, a year-on-year increase of 14.49%, and the R&D expenses will be 185 million yuan, a year-on-year increase of 20.56%.
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Source: Minenet database, company announcements
Note: The statistical scope of "China's Three Terminals and Six Major Markets" is as follows: urban public hospitals and county-level public hospitals, urban community centers and township health centers, urban physical pharmacies and online pharmacies, excluding private hospitals, private clinics, village clinics, and county and rural pharmacies;