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New pediatric medicine approved! Tasly takes the lead

Release date: 2019-12-27 Views: 0

Source: Minnet  

On December 27, Tasly issued an announcement saying that the exclusive pediatric new drug Ramie Zhijing Granules (formerly known as Zhidong Granules) received the Drug Registration Approval issued by the State Drug Administration. Data from Minnet.com shows that Hunan Sheng Pharmaceutical ’s exclusive pediatric new drug Pediatric Jingxing Zhike Granules has also entered the “issued” state, and nearly 8 billion pediatric proprietary Chinese medicines in Chinese public medical institutions have recently added multiple new products.

288.7 billion Chinese patent medicine market, the fastest growth in pediatric medicine

Table 1: Sales growth and market share of 13 major categories of public medical institutions in China in 2018

Source: Minnet.com China's public medical institution terminal competition pattern

According to Minnet.com, in 2018, the scale of the market for proprietary Chinese medicines in Chinese urban public hospitals, county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) has exceeded 288.7 billion yuan, a growth rate of 1.16%. The market size of pediatric drugs in 2018 is close to 8 billion yuan, with a growth rate of 14.21%, which is much higher than the horizontal line.

Segmented into various markets, pediatric medications account for 2% ~ 3% of the market share in urban public hospitals, county-level public hospitals, urban community centers, and township health centers due to the particularity of patient groups, but sales have increased The speed is more than 10%, and the performance is very eye-catching.

In recent years, the state has continuously issued a number of policies to support the development of pediatric medicines. Since 2013, China has accelerated the formulation of pediatric medicines and encouraged enterprises to produce pediatric special dosage forms and specifications. In 2014, "Several Opinions on Safeguarding Children's Medications" It is the first comprehensive guidance document on the use of children's medicines in China in the past ten years. From 2016 to 2019, the Health and Family Planning Commission, the Ministry of Industry and Information Technology and the Bureau of Drug Administration have successively launched three batches of children's medicines to encourage R & D declaration, a total of 108 kinds, which is rich. In addition to pediatric medicines, pediatric medicine registration applications have been included in the priority review list, which has greatly improved the speed of pediatric medicines on the market. The Health China Action Plan focuses on strengthening children's health protection measures, and the future of children's medicines in China is optimistic.

New pediatric drug development is difficult, only 4 have been approved for marketing in the past decade

Table 2: Pediatric proprietary Chinese medicines approved for marketing in the past decade

Source: MED China Drug Review Database 2.0

Table 3: Pediatric proprietary Chinese medicines that have completed review and approval

Source: MED China Drug Review Database 2.0

For a long time, because of the fragility of children's vital signs and the difficulty of tracking children's clinical response, the development of children's medicine has been difficult. According to the data of MIN China ’s MED China Drug Review Database 2.0, since 2010, only four new pediatric proprietary Chinese medicines have been approved for listing in the past ten years, including Ramie Xifeng Tablet, Xiaoer Ganmao Ning Granules, Pediatric Jianwei Chewable Tablets, and Ramie Antispasmodic granules, among which Ramie Xifeng Tablets, Pediatric Jianwei Chewable Tablets, Ramie Antispasmodic Granules are exclusive products.

The Ramie Xifeng Tablet of Jiren Pharmaceutical of Heilongjiang Province is a pediatric convulsion medicine, which has the effects of calming the liver and calming the phlegm, and is used for mild to moderate pediatric multiple tic disorder, which belongs to the traditional Chinese medicine liver wind internal phlegm syndrome. . In 2018, it ranked fifth in TOP20 of pediatric pediatric convulsions in Chinese public medical institutions, with a market share of 6.49%. After the product was approved for listing in 2014, the sales growth rate has been high, and the growth rates from 2016 to 2018 were 7282.22%, 132.36%, and 563.87%.

The pediatric healthy stomach chewable tablet of Shandong Buchang Shenzhou Pharmaceutical Co., Ltd. is used for pediatric anorexia, and it is listed as a major scientific and technological project of the 13th Five-Year Plan for "Major New Drug Creation". "Technology and its industrialization research" task 93 (Research on Chinese medicine flavor correction technology and its application in pediatric Jianwei chewable tablets), and received a government subsidy of 760,000 yuan on January 14, 2019.

Tasly's Ramie Zhijing Granules (formerly known as Zhidong Granules) is suitable for children with Tourette Syndrome, and its main functions are Pingganxifeng, Qinghu and phlegm, and peace of mind; used for liver hyperactivity, wind and phlegm. The tics caused by internal disturbances include involuntary twitching of muscles on the face, head and neck, limbs, or trunk, accompanied by abnormal vocalizations in the throat, irritability, dry mouth, red tongue, and disturbed sleep. The product was successfully included in the priority review in September 2018, citing innovative drugs and children's drugs with obvious therapeutic advantages. In 2018, the scale of the market for Chinese patent medicine pediatric convulsions in public medical institutions in China has reached 140 million yuan, and the potential of new drugs to be marketed needs to be verified.

Fang Sheng Pharmaceutical's exclusive product Xiaoer Jingxing Cough Granules is mainly used to treat cough, expectoration, yellow phlegm, redness, swelling and fever caused by exogenous wind chills and mild mild bronchitis in children. At present, the product has been reviewed. Approval. Fang Sheng Pharmaceutical said that as of the end of 2018, the company invested about 3.741 million yuan in the research and development of the drug. The product has obvious therapeutic effects and good safety. If it can be successfully marketed in the future, it will further enrich the company's pediatric product line and improve the company's Competitiveness of the pediatric disease medication market. In 2018, the market size of Chinese patent medicine pediatric antitussive and expectorant drugs in public medical institutions in China reached 2.9 billion yuan.

Priority review to help new drugs to market, these 3 new drugs have been approved for clinical

Table 4: Pediatric proprietary Chinese medicines that have been included in the priority review since 2010

Source: MED China Drug Review Database 2.0

In addition to Tasly's Ramie Zhijing Granules, Xiaoer Malong Zhike Pingchuan Granules, Xiaoer Qinger Oral Liquid, and Susu Xiaoer Zhike Granules were also included in the priority review in October 2016, July 2017, and January 2018, respectively. Comments, three new drugs have been approved clinically.

Tasly mentioned in the 2018 annual board review, that Susu Xiaoer Zhike Granules has been clinically approved, and it is expected that this product will be included in Tasly's pockets in the future. Pediatric Qingzha Oral Liquid has been applied for phase Ⅱ clinical trial by China Resources Sanjiu Medicine and is currently in progress. Huluwa's Pediatric Healing Cough and Pingchuan Granules is an innovative drug used to treat allergic cough in children. The latest news indicates that Phase II clinical trials of this product are in progress.

Table 5: Status of non-priority review of proprietary Chinese medicines in pediatrics that have been approved clinically since 2010

Source: MED China Drug Review Database 2.0

Among the non-priority new pediatric drugs, at present, 6 types of new drugs for pediatric spleen and stomach granules are currently under review and approval. In addition, 7 new drugs have been approved for clinical use, including Xiaoer Yanlining Oral Liquid and Pediatric Chemicals. The granules, pediatric cockroach heat-reducing syrup, pediatric artemisinin anti-sense granules, pediatric antidiarrheal babies cream, pediatric Xuanfei cough syrup are expected to become exclusive new products in the pediatric proprietary Chinese medicine market in the future.

Conclusion

Judging from the current situation, Tasly, Culuwa, Jichuan Pharmaceutical, and China Resources Sanjiu have spared no effort in the layout of the pediatric proprietary Chinese medicine market: Tasly has approved 1 exclusive new product and 1 product has been approved for clinical use; Cucurbit 2 exclusive new products Approved for clinical trials, Phase II clinical trials of Pediatric Malong Zhike Pingchuan Granules are underway; Jichuan Pharmaceutical, a leading pediatric proprietary Chinese medicine company, and Phase III of Pediatric Auricular Clear Heat Syrup are also underway; The Phase II clinical trial of Pediatric Qingzha Oral Liquid is also in progress ... Although there is a problem in the development of children's medicine, etc., with the support of national policies and the efforts of enterprises, the pediatric Chinese patent medicine market is expected to continue to drive the Chinese patent medicine market higher. Maximum power.

Source: Minet data, company announcement


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