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【Pharmaceutical Network Enterprise News】Recently, "pharmaceutical brother" Hengrui Pharmaceutical announced that the company's levobupivacaine hydrochloride injection passed the quality and efficacy consistency evaluation of generic drugs, and the product is an amide long-acting local anesthesia and analgesic, mainly used for the treatment of surgical epidural block anesthesia
.
Data shows that in 2021, global sales of levobupivacaine-related dosage forms were approximately $39.
5 million.
Up to now, the company has invested a total of about 4.
19 million yuan
in R&D expenses for the consistency evaluation of generic drugs of levobupivacaine hydrochloride injection.
The consistency evaluation of generic drugs means that for generic drugs that have been approved for marketing, according to the principle of consistency with the quality and efficacy of the original drug, the generic drug needs to reach the same level
as the original drug in quality and efficacy.
According to relevant national policies, drug varieties that have passed the consistency evaluation will receive greater support in the fields of medical insurance payment and medical institution procurement
.
It is reported that Hengrui Pharmaceutical actively promotes the consistency evaluation of generic drugs, up to now, the company has accumulated 26 products have been evaluated, 32 products are regarded as evaluation, and 8 products are in the process of
application for approval.
Among them, since 2022, in addition to levobupivacaine hydrochloride injection, Hengrui Pharmaceutical has also had a number of varieties evaluated or deemed to have been evaluated, and there is no lack of the first varieties
to be evaluated.
For example, on May 27, NMPA released a batch of drug approval documents to be collected, among which, the 4-class generic drug Diquafosso sodium eye drops of Chengdu Shengdi Pharmaceutical, a subsidiary of Hengrui Pharmaceutical, was approved for marketing, and won the first generic + first evaluation
of the product.
Quafusol sodium is a P2Y2 receptor agonist that acts on the P2Y2 receptor on the conjunctival epithelium and goblet cell membranes, and improves dry eye symptoms
by upregulating the concentration of calcium ions in cells and promoting the secretion of water and mucin.
According to statistics, in H1 2022, the sales of dry eye eye drops in hospitals across the country increased by 171% year-on-year, nearly 60 million yuan, and this year is expected to exceed the 100 million yuan mark
.
On May 23, Hengrui Pharmaceutical announced that the company received the "Drug Supplement Application Approval Notice" approved and issued by the State Medical Products Administration, and the company's butorphanol tartrate injection passed the consistency evaluation of the quality and efficacy of generic drugs, and won the first domestic evaluation
.
Data show that butorphanol tartrate injection will have nearly 1.
6 billion yuan in hospital sales in China in 2021, a year-on-year increase of 6%.
In March, Hengrui Pharmaceutical's gadolinium butrol injection was approved for marketing, which is deemed to have passed the consistency evaluation of the quality and efficacy of generic drugs, and is the first "reviewed" enterprise
in China.
Gadolinium butrol injection is a paramagnetic contrast agent
used in magnetic resonance imaging (MRI).
Data shows that the global sales of gadolinium-related dosage forms in 2021 were about $495 million
.
In January, Shandong Shengdi Pharmaceutical Co.
, Ltd.
, a subsidiary of Hengrui Pharmaceutical, approved ambroxol hydrochloride oral solution for marketing, and this approval is regarded as passing the consistency evaluation
of the quality and efficacy of generic drugs.
Ambroxol hydrochloride oral liquid can increase the secretion of serous glands of the respiratory tract mucosa and reduce the secretion of mucus glands, and is suitable for thick sputum and difficult
coughing up sputum caused by acute and chronic bronchitis.
Data show that ambroxol hydrochloride oral solution had in-hospital sales of 127 million yuan
in 2021.
In addition to Hengrui, this variety has been evaluated, including Beijing Yijia Xinchuang Medical (the first generic drug to be evaluated), Heilongjiang Guikang Pharmaceutical, etc
.
Hengrui Pharmaceutical's rich harvest of generic drugs is inseparable from continuous R&D investment, and the company has actively transformed
into innovative drugs in recent years.
According to the financial report data, the company's R&D investment in the first three quarters reached 3.
497 billion yuan, with a total of more than 80 drugs in the pipeline of innovative drugs under development, 11 drugs have been listed, 5 NDA (new drug applications), and more than 50 phase III clinical trials
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.