Highlights
In 2023, Yiling Pharmaceutical, a leading enterprise in traditional Chinese medicine innovation, will achieve excellent results, and the new cough drug Lianhua Qingtussive Tablets will be successfully converted to OTC after being included in the medical insurance negotiation catalog, and sales are expected to usher in a new explosive period. The first class 1 new drug of ophthalmic Chinese medicine, Tongluo Mingmu Capsule, was approved, the class 1 new drug of rhinitis Chinese medicine, Xinqitong Nasal Tablets, was submitted for production and review, and 7 new Chinese medicine drugs were accelerated to accelerate clinical practice. In the field of biochemistry, the market share of the bid-winning products of the national procurement has soared, laying the foundation for the company to develop the chemical drug market, and the new drug aniliprofen injection of class 1 of chemical drugs is about to be put into production, and there are 3 new drugs of chemical drugs and 1 class 1 of biological drugs. With the successive implementation of innovative achievements, Yiling Pharmaceutical's leading position will be further consolidated and enhanced.
Class 1 new drugs in ophthalmology have been approved, and Class 1 new drugs for rhinitis are sprinting
In recent years, Yiling Pharmaceutical's innovation strength has been continuously improved, and in terms of new Chinese medicine drugs, it has strengthened the construction of the evidence system for the registration and review of traditional Chinese medicine that combines traditional Chinese medicine theory, human experience, and clinical trials, continuously improved the efficiency of R&D output, and enriched the R&D product array.
According to data from Minenet, since 2020, Yiling Pharmaceutical has 4 new Chinese medicine drugs approved, and 1 new Chinese medicine drug will be declared for listing in 2023, and there are currently 7 new Chinese medicine drugs actively promoting clinical practice.
Table 1: New Chinese medicine drugs approved by Yiling Pharmaceutical since 2020 (statistics by approval date)
Source: Minenet China Declaration Progress (MED) database
Approved in May 2020, Lianhua Qingcough Tablets is a new Chinese medicine for the respiratory system for the treatment of cough and other symptoms caused by acute tracheo-bronchitis and phlegm-heat syndrome, which is guided by the theory of traditional Chinese medicine and developed by traditional classic prescriptions and clinical practice. In December 2020, Lianhua Qingcough Tablets successfully entered the medical insurance catalog through negotiations, and in November 2023, the State Food and Drug Administration issued an announcement showing that the product was converted from a prescription drug to an over-the-counter drug, and the policy dividend continued to increase, which is expected to drive the rapid increase in product sales.
Figure 1: Sales of Lianhua Cough Tablets (unit: 10,000 yuan)
Source: Minenet Grid Bureau Database
In recent years, the total sales of Lianhua cough tablets have risen rapidly in China's three major terminal markets (see the end of the article for statistical scope), and the cumulative sales in the first half of 2020-2023 have exceeded 180 million yuan, and the market potential should not be underestimated.
In 2021, Yiling Pharmaceutical Co., Ltd. has two new traditional Chinese medicine drugs for the nervous system, Yixing and Xinxin Tablets are new traditional Chinese medicine drugs for the treatment of insomnia based on the theory of network disease, and Jieyu and Troublefree Capsule is a new traditional Chinese medicine for the treatment of mild and moderate depression developed by Zhongjing Jingfang in the Han Dynasty. The company's R&D strength has been recognized by patients at the national level, and the company said that in the future, with the continuous enrichment of academic evidence and the gradual improvement of coverage, the sales of products are expected to achieve sustained and rapid growth.
In October 2023, Tongluo Mingmu Capsule was approved, the product is the first ophthalmic Chinese medicine class 1.1 new drug, is an innovative Chinese medicine developed on the basis of clinical experience under the guidance of the theory of traditional Chinese medicine, mainly for the treatment of type 2 diabetic retinopathy non-proliferative and preproliferative patients, the product features to protect retinal microvessels and blood-retinal barrier, improve retinal function, and effectively treat diabetic retinopathy. Yiling Pharmaceutical has said that after the approval of Tongluo Mingmu Capsule, it can play a synergistic role with Jinlida granules to provide more drug options for patients with diabetes accompanied by retinopathy.
Table 2: Some blockbuster new Chinese medicine drugs under development by Yiling Pharmaceutical (excluding new indications)
Source: Minenet comprehensive database, company announcements
In November 2023, Yiling Pharmaceutical will apply for the listing of another new Chinese medicine drug, Xinqitong Nasal Tablets for persistent allergic rhinitis, lung and spleen deficiency syndrome, and the new drug is expected to become the first approved new drug of rhinitis Chinese medicine Class 1.1.
Yiling Pharmaceutical has mentioned in the semi-annual report and annual report that the company plans to declare 1-2 varieties every year, and the layout direction includes multiple subdivisions such as upper respiratory tract/lower respiratory tract/pediatric respiratory system in the field of large breathing, endocrine fields such as diabetic retinopathy, diabetic foot, diabetic nephropathy, hyperuricemia and other subdivided diseases, four organ diseases in the field of gastrointestinal and hepatobiliary diseases, gynecology and pediatric diseases, in addition to the ENT department, immune diseases, rheumatoid customs, rare diseases and other directions.
The number of exclusive Chinese patent medicines has increased to 21! The large varieties of cardiovascular and cerebrovascular and respiratory systems are super eye-catching
As the company's new TCM drugs under development have entered the harvest period, Yiling Pharmaceutical's exclusive product matrix has gradually expanded, and the company's exclusive products have increased to 21 by 2023, involving 8 categories, and its exclusive Chinese patent medicines for the central cerebrovascular and respiratory systems have been in the leading position in the industry.
Table 3: Yiling Pharmaceutical's exclusive proprietary Chinese medicines
Source: Minenet China Listed Drugs (MID) Database
In the field of cardiovascular and cerebrovascular diseases, the company's ginseng song Yangxin capsule and Tongxinluo capsule will have a total sales of more than 2 billion yuan in China's three major terminals and six major markets in 2022, and Qili Qiangxin Capsule has exceeded 1.8 billion yuan, with outstanding results, and the treatment scope of three exclusive Chinese patent medicines covers the three most common indications of ischemic cardiovascular and cerebrovascular diseases, arrhythmia, and heart failure in cardiovascular and cerebrovascular diseases.
Table 4: Sales of 3 exclusive proprietary Chinese medicines for cardiovascular and cerebrovascular diseases in the first half of 2023
Source: Minenet's competitive landscape of drug terminals in China's public medical institutions
In the first half of 2023, the sales of Ginseng Song Yangxin Capsule and Tongxinluo Capsule will exceed 1 billion yuan, which is the TOP5 and TOP6 brands of internal medication for cardiovascular and cerebrovascular diseases, and the sales of Qili Qiangxin Capsule are more than 700 million yuan, the brand ranks TOP7, and the three exclusive Chinese patent medicines have positive growth.
In the field of respiratory diseases, the company's Lianhua Qingwen Capsule and Lianhua Qingwen Granules will have a total sales of more than 3 billion yuan in China's three major terminal and six major markets in 2022. The main sales position of Lianhua Qingwen Capsule is the retail pharmacy terminal (urban physical pharmacy + online pharmacy), with a total sales of more than 800 million yuan in the first half of 2023, of which the growth rate of online pharmacy terminals in China has reached 172.41%. The main sales position of Lianhua Qingwen Granules is the terminal of China's public medical institutions, with sales of more than 1 billion yuan in the first half of 2023, with a growth rate of 13.97%.
The share of the bid-winning products of the national procurement has soared, and the first class 1 new chemical drug is coming
In recent years, Yiling Pharmaceutical has also been actively deploying the field of biochemistry, and the company has formulated a development strategy of chemical and biological drugs that is "transfer and processing - international and domestic double registration of generic drugs - R&D, production and sales of patented new drugs". Since 2021, the company has approved 1 blockbuster chemical drug every year, and gradually expanded the chemical drug product matrix, and the number of evaluated products has reached 16 so far.
Table 5: Chemical drugs approved by Yiling Pharmaceutical since 2021 (statistics by approval date)
Source: Minenet China Declaration Progress (MED) database
Yiling Pharmaceutical actively participated in the national centralized procurement, and won the bid for captopril tablets, metformin hydrochloride tablets, and ciprofloxacin hydrochloride tablets in the third batch of national procurement, metoprolol tartrate tablets in the fifth batch of national procurement, and isosorbide mononitrate tablets in the seventh batch of national procurement. In the first half of 2023, with the help of Guocai, the company has become the TOP1 enterprise of ciprofloxacin hydrochloride tablets, the TOP2 enterprise of captopril tablets, and the TOP3 enterprises of isosorbide mononitrate tablets in China's public medical institutions, gradually expanding its market competitiveness.
Table 6: Some blockbuster new chemical and biological drugs under development in Yiling Pharmaceutical
Source: Minenet comprehensive database, company announcements
It is reported that the new drug anilineprofen injection, a new chemical drug class 1.1 for postoperative analgesia, is about to be reported for production, which is a non-steroidal analgesic, which was approved for clinical trial for the first time in 2010, a phase I clinical trial was launched in 2014, and a phase III clinical trial will be completed in 2022. At present, Yiling Pharmaceutical has only one anesthetic lidocaine hydrochloride injection in the neurological chemical drugs (including biological drugs) market, and if aniliprofen injection is successfully approved, it will not only become the company's first approved chemical drug Class 1.1 new drug, but also further enhance the company's competitiveness in the nervous system chemical drugs (including biological drugs) market, which is worth looking forward to.
BIO-008 is a monoclonal antibody targeting Claudin18.2, and the phase I clinical trial of advanced solid tumors was officially launched in April 2023.
Sources: Minenet database, company announcements, etc
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; The statistics are as of January 9, 2024, if there are any omissions, please correct!