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In recent years, Shijiazhuang Four Medicines has vigorously promoted scientific research innovation and structural optimization business measures, persistently promoted the coordinated development of R&D and consistency evaluation of innovative drugs and generic drugs, and vigorously implemented the "raw materials + preparations" business strategy, with remarkable
results.
Up to now, the company has 33 products evaluated, most of which are newly classified products are regarded as evaluations; 45 high-end generic drugs are sprinting to market, of which 17 products will strive for the approval of the first three, and the strength of imitation cannot be underestimated; The company's first Class 1 new drug has attracted much attention and will launch an attack
on the 100 billion anti-tumor drug market.
R&D costs increase year by year, and Class 1 new drugs follow
With the continuous advancement of medical reform, the superimposed impact of various new policies, the intensification of the reform of the domestic pharmaceutical market, the acceleration of the transformation of domestic pharmaceutical enterprises, and the improvement and empowerment of high-quality development of enterprises through innovation have become a general trend
.
According to the data of the annual report of Shisi Pharmaceutical Group, the company's R&D cost reached HK $127 million in 2020, an increase of 95% in 2021 to HK $248 million, and the R&D cost in the first half of 2022 is close to the whole year of 2020, and the company's innovation and transformation continue to accelerate
。
Figure 1: R&D costs of Shisi Pharmaceutical Group (HK$100 million)
Source: Company annual report, semi-annual report
Figure 2: Class 1 new drugs that have been approved for clinical trials
Source: Minainet new version of data
The company's first Class 1 new drug was approved for clinical trial in 2020, which is of great significance
.
NP-01 is a moderately selective KDR/MET/AXL multi-target kinase inhibitor jointly developed by the company and domestic research institutions, and studies have shown that NP-01 shows excellent anti-tumor activity
in various tumor animal models such as gastric cancer, liver cancer, lung cancer, and prostate cancer.
In recent years, the research and development of new anti-tumor drugs in China has been very hot, and the new drugs have achieved rapid take-off with the help of medical insurance after they are launched, and the market scale has continued to increase
.
According to data from Minai.
com, the total sales of anti-tumor drugs in the six major markets of the three major terminals in 2021 (see the end of the article for statistical scope) exceeded 138 billion yuan, and the total sales growth rate in the past two years remained in double digits, and the market potential should not be
underestimated.
The data show that the phase I clinical study of NP-01 tablets of Shisi Medicine for advanced malignant solid tumors is ongoing
.
In addition, the company's ADN-9 is grasping to improve the data and strive to apply for phase I clinical trials within the year, the new drug is an anti-liver fibrosis class 1 new drug, the preliminary research data shows that ADN-9 high efficiency, low toxicity and multi-target comprehensive effect and other characteristics are outstanding, the prospect of the treatment of complex diseases of liver fibrosis is very promising, if successfully listed is expected to fill the domestic gap
。
12 new products have been harvested this year! The 33 rated products are super eye-catching
Table 1: New products approved by Shisi Pharmaceutical since 2022
Source: Minai.
com China Declaration Progress (MED) database
Up to now, Shisi Pharmaceutical has won 12 high-end generic drugs this year, all of which have been approved according to the new classification
.
The company's Bunanserin tablets are the first imitation in China, the original research products entered the domestic market in 2017, entered the medical insurance negotiation catalog in 2020, and are now the 2021 edition of the national medical insurance negotiation catalogue Class B varieties, used for mental division/splitting, and the total sales in the three major terminal markets in 2021 exceeded 36 million yuan
.
Shisi Pharmaceutical was declared for marketing in February 2021 and approved
in June 2022.
The company's acetaminophen mannitol injection was declared for marketing in October 2020 and approved
in June 2022.
Shisi Yao is the first approved enterprise for the indication of alleviating fever in adults, and Hengrui was previously approved for the indication of auxiliary opioid analgesics for the relief of moderate to severe pain
in adults after surgery.
In addition, the company's product line has also ushered in a number of new breakthroughs: moxifloxacin hydrochloride eye drops are the company's first approved ophthalmic preparation, and valsartan amlodipine tablets (I.
) is the company's first approved compound preparation; Ipratropium bromide solution for inhalation is the second inhalant approved by the Company, and azithromycin dry suspension is the second dry suspension approved by the Company
.
Table 2: The products that have been evaluated so far
Source: Minai.
com China Listed Drugs (MID) database
Up to now, the number of products that have been evaluated/deemed to have been evaluated has reached 33 (according to product name), and the number of products approved as evaluated according to the new classification has increased
year by year.
The company's doxofylline injection, ropivacaine hydrochloride injection, ciprofloxacin lactate sodium chloride injection, azithromycin dry suspension, bunanserin tablets, peritoneal dialysate (lactate-G1.
5%) and pentoxifylline injection are the first in China to have been evaluated
.
Shisi Pharmaceutical has said that it is necessary to give full play to the advantages of iterative innovation of generic drugs, actively participate in national procurement with the help of the results achieved by consistency evaluation, and continuously expand the market accessibility and influence
of the company's preparation products 。 The company participated in the third batch, fourth batch, fifth batch, seventh batch of national procurement, cefdinib capsules, prucalopride succinate tablets, doxofylline injection, ambroxol hydrochloride injection, fluconazole sodium chloride injection, ropivacaine hydrochloride injection, bromohexine hydrochloride injection, cefaclor dry suspension A total of 8 products won the bid, the company's half-year report data shows that the sales of the winning products in the first half of 2022 reached HK $132 million, a year-on-year increase of about 260%.
The company said that it will seize the market opportunity of the eighth batch of national procurement and further expand the market share and influence
of consistency evaluation products.
Up to now, methylcobalamin injection, metronidazole sodium chloride injection, hydroxyethyl starch 130/0.
4 sodium chloride injection, ciprofloxacin lactate sodium chloride injection and levofloxacin injection have reached more than 4 competitive patterns (original research + evaluated enterprises ≥ 3), Shisi Pharmaceutical has the opportunity to participate in the bidding
。
45 high-end generic drugs rushed to market, and the strength of imitation should not be underestimated
While fully promoting the research and development of innovative drugs, Shisi Yao's generic drug R&D efficiency, approved quantity, and declared number are among the best in the same industry in China, and it is currently entering the harvest period of concentrated results, and the company's product line portfolio will become increasingly rich
in the future 。
Table 3: Generic drugs currently reported for production and under review by Shisi Medicine
Source: Minai.
com China Declaration Progress (MED) database
At present, Shisi Pharmaceutical has 45 generic drugs declared for marketing and are in the process of review and approval, all of which are declared according to the new classification, and after approval, they are regarded as having been evaluated, and the company's two major categories of systemic hormone preparations (excluding sex hormones and insulin), genitourinary system and sex hormone drugs are expected to usher in the first approved product
.
Linezolid sodium chloride injection, terdizolide phosphate tablets, linezolid dry suspension, stipentanol dry suspension, mannitol sorbitol injection 5 products have not yet been approved by domestic pharmaceutical companies, Shisi drug is expected to strive for the first imitation
in China.
Doxofylline granules, sorbitol mannitol rinse, pentoxifylline sustained-release tablets, tirofiban hydrochloride injection 4 products Only 1 domestic pharmaceutical company has been approved, Shisi Pharmaceutical will strive for the second domestic one, of which pentoxifylline sustained-release tablets in 2021 in the three major terminal 6 major markets with a total sales of more than 100 million yuan
。
Terdizolid phosphate for injection, Arbidol hydrochloride tablets, cefuroxime ester dry suspension, rasagiline mesylate tablets, entacapone tablets, urapidil hydrochloride injection, nifedipine sustained-release tablets, nicorandil for injection 8 products At present, 2 domestic pharmaceutical companies have obtained approval, Shisi Medicine can strive for the third domestic production, of which the total sales of uradil hydrochloride injection and nicorandil for injection in the three major terminal markets in 2021 have exceeded 1 billion yuan
。
Figure 3: Products with sales of more than CNY 1 billion in the six major markets of the three major terminals in 2021
Source: Minai Grid Bureau database
If the above 17 products under review are successfully approved by the first three, Shisi Pharmaceutical will have a first-mover advantage and can quickly occupy the market
.
In addition, the company also challenges some large varieties, propofol medium/long chain fat emulsion injection, lipoic acid injection, epasstat tablets, felodipine sustained-release tablets in 2021 in the three terminal 6 major markets with a total sales of more than 1 billion yuan, with the company's continuous improvement of brand effect, latecomers can also seize a place
.
Source: Company annual reports and announcements, Minainet database, etc
Note: Minai.
com's "Drug Competition Pattern of China's Three Major Terminal and 6 Major Markets", the statistical scope is: 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, excluding county and rural pharmacies; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of November 18, if there are any omissions, welcome to correct.
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