Original croissant meter intranet
Highlights
Recently, China Resources Shuanghe's product line has made continuous progress: lidocaine hydrochloride injection has been approved for marketing, piracetam injection has been evaluated, and semaglutide injection has been approved for clinical ...... Since 2021, 34 new products of CR Shuanghe have been approved for marketing, and the product line has entered an intensive harvest period. At present, the company has 75 varieties that have been evaluated (7 first), and 20 varieties have won the bid for national procurement; 38 new classified products are under review, and 4 new drugs are being developed.
Generic drugs exploded! Won 34 blockbuster varieties
On May 7, China Resources Shuanghe announced that the lidocaine hydrochloride injection of its wholly-owned subsidiary, Shuanghe Limin, was approved for marketing and was deemed to have been evaluated. Lidocaine hydrochloride injection is a local anesthetic and anti-arrhythmic drug, which is the eighth variety approved for marketing by China Resources Shuanghe (including subsidiaries, the same below) this year.
In recent years, CR Shuanghe's product line has entered an intensive harvest period, and the number of new products approved annually has grown from a handful to more than double digits.
In 2020, only 3 varieties of CR Shuanghe were approved for marketing, the same as in 2019. Entering 2021, the number of approved varieties of the company has increased significantly, with 6 varieties approved for marketing in 2021 and 9 varieties in 2022; In 2023, the approved varieties will stand in double digits - 12.
Since 2021, CR Shuanghe has been approved as a variety
Since 2021, 34 varieties of CR Shuanghe have been approved for marketing (excluding supplementary applications), further enriching the company's product line.
Since 2024, CR Shuanghe has 8 varieties approved for marketing and deemed to have been evaluated, including glipizide controlled-release tablets, apixaban tablets, levetiracetam sustained-release tablets, doxazosin mesylate sustained-release tablets, sodium valproate concentrated solution for injection, mirabegron sustained-release tablets, linezolid glucose injection, and lidocaine hydrochloride injection. Among them, doxazosin mesylate sustained-release tablets are the fourth in China, and levetiracetam sustained-release tablets are the fifth in China.
75 varieties have been evaluated, and 4 major 100 billion markets have been attacked
On May 13, China Resources Shuanghe announced that the piracetam injection of Shuanghe Limin, a wholly-owned subsidiary, and the peritoneal dialysate (lactate-G1.5%), peritoneal dialysate (lactate-G2.5%), and peritoneal dialysate (lactate-G4.25%) of the wholly-owned subsidiary Shanghai Changzheng Fumin Jinshan Pharmaceutical passed the consistency evaluation of generic drugs, which is conducive to future market sales and market competition.
Up to now, 75 varieties of CR Shuanghe have passed/are deemed to have passed the consistency evaluation. Among them, 7 varieties are the first to be evaluated in China, including irbesartan dispersible tablets, finasteride tablets, gliquinone tablets, caffeine citrate injection, clozapine oral disintegration tablets, terazosin hydrochloride tablets, and ofloxacin sodium chloride injection.
CR Shuanghe has passed/deemed to have passed the consistency evaluation of varieties
The 75 evaluated varieties covered 11 treatment categories, mainly focusing on cardiovascular and cerebrovascular system drugs (15), nervous system drugs (14), systemic anti-infective drugs (13), digestive system and metabolic drugs (12).
According to data from Minenet, in 2023, the sales of systemic anti-infective drugs, digestive system and metabolic drugs in the chemical drug terminals of China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (hereinafter referred to as China's public medical institutions) will exceed 100 billion yuan, and the sales of nervous system drugs and cardiovascular and cerebrovascular system drugs will be close to 100 billion yuan.
Among the eight batches of centralized procurement of chemical drugs that have been implemented, a total of 20 varieties (excluding contract renewals) have been selected by CR Shuanghe. As more of the company's "barefoot" products enter the centralized procurement, to a certain extent, it makes up for the loss of the price reduction of the existing products.
In terms of supplementary applications for consistency evaluation, CR Shuanghe currently has 11 varieties under review, including 10 injections, including vitamin B6 injection, sodium bicarbonate injection, potassium chloride injection, progesterone injection, famotidine injection, busulfan injection, aminophylline injection, and pentazocine injection. Among them, vitamin B6 injection and progesterone injection were the first to be evaluated.
China Resources Shuanghe Consistency Evaluation Supplementary Application for Varieties under Review
Source: Minenet Consistency Evaluation Progress Database
38 new products on the way! Grab $13.9 billion in varieties
In recent years, CR Shuanghe has stepped up its efforts to support drug R&D and innovation, with R&D expenses of RMB482 million in 2022, a year-on-year increase of 17.80%; In 2023, the R&D expenses will be 561 million yuan, a year-on-year increase of 16.37%.
In terms of generic drugs, CR Shuanghe currently has 38 new registration and classification varieties under review for marketing, which will be deemed to have passed the consistency evaluation after approval for production, further enriching the company's product portfolio in various fields.
Among the 38 varieties, perindopril amlodipine tablets (III.) have not been approved for marketing in China, and the company is expected to win the first generic drug; Indocyanine green for injection, fenofibrate choline sustained-release capsules, and amlodipine benazepril capsules have only one generic drug approved for marketing in China, and the company is expected to achieve the first batch of marketing.
CR Shuanghe is mainly developing new drugs
In terms of new drug research and development, China Resources Shuanghe's mercaptopurine microtablets (for the treatment of childhood leukemia) and octafluoropropane lipid microsphere injection (liver ultrasound microbubble contrast agent) have submitted marketing applications; Category 1 new drug CX2101A (for the treatment of novel coronavirus infection) is in phase I clinical research stage; Semaglutide injection (for adults with type 2 diabetes) has been approved for clinical trials, and Novo Nordisk's semaglutide injection Ozempic (type 2 diabetes) revenue will be $13.9 billion in 2023, a year-on-year increase of 60%.
Source: Minenet database, company announcements
Note: The statistical scope of "Drug Terminal Competition Pattern of China's Public Medical Institutions" by Minenet is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics and village clinics; The above sales are calculated based on the average retail price of the product at the terminal. If there is any omission in the data statistics, please correct it.