The first batch of large varieties has been reviewed: Hengrui, Jichuan, Northeast Pharmaceuticals...

Since the beginning of the year, many pharmaceutical companies have crossed the line for the first time.

01 The first review of 20 major varieties

Cyberblue's inquiry from the National Drug Approval Center found that, according to incomplete statistics, from January to February 2022, 20 varieties have been evaluated for the first time

include:

Shanghai Shikangte’s famotidine tablets, Jinling Pharmaceutical’s ferrous succinate tablets, Northeast Pharmaceutical’s carboprost tromethamine injection, Beijing Hanmei’s amlodipine and losartan potassium tablets (II), Jiangsu Zhiyuan's Methotrexate Tablets, Jichuan Pharmaceutical's Magnesium Sodium and Potassium Sulfate Oral Concentrated Solution, Ruiyang Pharmaceutical's Lincomycin Hydrochloride Injection, Xiamen Deloitte's Entecavir Tablets, Beijing Hanmei's Amlodipine Chloride Sartan Potassium Tablets (Ⅰ), Sitagliptin Metformin Sustained-Release Tablets from Nanjing Chia Tai Tianqing, Cetrorelix Acetate for Injection from Livzon Pharmaceuticals, Valsartan Dispersible Tablets from Hainan Huanglong, and Injections from Jianjin Pharmaceuticals Calcium levofolinate, Roxatidine hydrochloride acetate for injection from Ruiyang Pharmaceuticals, Teriflunomide tablets from Shengshi Tech, Calcitriol Soft Capsule from Sichuan Guowei and Henan Taifeng, and Amethyst Hydrochloride from Shijiazhuang Green Rollol tablets, Hengrui's ondansetron oral dissolving film, acetaminophen injection and nimodipine oral solution

The first review is of great significance to the company and can help it further expand the market

Taking Nanjing Chia Tai Tianqing's sitagliptin metformin sustained-release tablets as an example, sitagliptin and metformin is a hypoglycemic drug compound with two complementary mechanisms of action combined with diet and exercise therapy.

According to the data from Minet.

In 2021E, the TOP5 brands of non-insulin hypoglycemic drugs for physical pharmacy terminals in Chinese cities are all foreign brands, including Bristol-Myers Squibb's Metformin Hydrochloride Tablets, AstraZeneca's Dapagliflozin Tablets, and Bayer's Acarbose Tablets

According to the data of the 2019 ADA/CDS joint seminar, the disease awareness rate, treatment rate and fasting blood glucose compliance rate of Chinese adult diabetic patients were 38.

Although the hypoglycemic drug market has long been led by unilateral preparations such as metformin, with the market share of compound preparations such as sitagliptin and metformin increasing year by year, it has shown a rising trend.

There are also concentrated solutions of magnesium sodium and potassium sulfate for oral administration from Jichuan Pharmaceutical, and magnesium sulfate oral liquid is a solution, which is a laxative

02 Hengrui's 3 major varieties won the first pass evaluation qualification

From January to February 2022, as of now, Hengrui's three major varieties have achieved the first over-review, including ondansetron oral dissolving film, acetaminophen injection and nimodipine oral solution

Ondansetron is a selective 5-HT3 receptor antagonist indicated for the control of nausea and vomiting induced by cancer chemotherapy and radiation therapy and for the prevention and postoperative nausea and vomiting

According to data from Minet.

Cyberblue searched the National Drug Approval Center and found that there were 9 entries about "ondansetron"

At present, the best-selling dosage forms on the market include injections and tablets.

Acetaminophen pain reliever for fever caused by the common cold or influenza, also for the relief of mild to moderate pain such as headache, joint pain, migraine, toothache, muscle pain, neuralgia, dysmenorrhea

Acetaminophen tablets are one of the second batch of domestically harvested varieties.
According to the data of the WeChat public account "Yao Chunqiu", the sales of acetaminophen in domestic sample hospitals in 2020 will decline significantly, and the annual harvest is 10.
35 million yuan.
A year-on-year decrease of 46.
29%, the original research Johnson & Johnson accounted for more than 70% of the market
.

Nimodipine belongs to the second generation of dipine drugs.
It was used for the treatment of hypertension in the early stage, and now it is mostly used for the prevention and treatment of ischemic nerve damage caused by cerebral vasospasm after aneurysmal subarachnoid hemorrhage
.

According to data from Minet.
com, the sales of nimodipine in China's public medical institutions will exceed 700 million yuan in 2020.
In the first half of 2021, there will be a slight year-on-year decline.
Bayer has the largest market share
.
Hengrui's first review this time will challenge the original market structure of the drug
.

The performance report for the third quarter of 2021 shows that Hengrui achieved operating income of 6.
9 billion yuan, down 14.
84% from the same period last year; net profit was 1.
539 billion yuan, down 3.
57% year-on-year
.
From the perspective of research and development, 4.
142 billion yuan was invested in the first three quarters of 2021, a year-on-year increase of 23.
86%, accounting for 20.
5% of revenue
.

Although Hengrui stated earlier that it "stopped general generic drug projects and only made innovative drugs and high-end generic drugs with core value"
.
However, on the recent R&D day, Hengrui's caliber was adjusted to "deeply tap the potential of traditional generic drugs"
.

Judging from the development of Hengrui's generic drugs, the attitude towards generic drugs may be more cautious in the future
.

According to the past situation, every year, a large number of drugs will be first over-evaluated.
In addition, there are also a large number of drugs that are exclusively declared.
For pharmaceutical companies, no matter how large the amount of the drug is to achieve the first over-evaluation, Its leading entry into the market has played a major role in promoting
.