This blockbuster Class 1 new drug is about to be approved, and sales are expected to exceed 2 billion yuan

【Pharmaceutical Network Product Information】It is reported that the Class 1 new drug TRV130, which Enhua Pharmaceutical intends to be widely used for postoperative moderate to severe analgesia, will be approved soon
.
The company has said on the interactive platform on October 14, 2022 that the company continues to pay attention to the approval dynamics of TRV-130, and is expected to be approved for listing around the end of the year, the approval of the product will further enrich the company's anesthesia product line, the company is optimistic about the future market prospects of the product, and is expected to make a greater contribution
to the company's future performance growth.
According to industry estimates, the class 1 new drug TRV130 will be approved for marketing in China around the end of 22, and it is expected to be negotiated for inclusion in medical insurance
at the end of 23.
Surgical patients have a high rate of acute postoperative pain, and severe postoperative pain can cause severe discomfort to patients, and can also delay postoperative recovery due to strong stress responses, and even induce complications
.
Good pain management is an important part of accelerating rehabilitation surgery, which can promote postoperative recovery, shorten the length of hospital stay, reduce inpatient medical costs, and improve patient satisfaction
.
At present, systemic analgesics commonly used after surgery include opioids, nonsteroid antiinflammatory drugs (NSAIDs)/acetaminophen, ketamine, dexmedetomidine, etc.
, but there are different side effects, such as commonly used opioids, which may be at risk
of adverse reactions such as vomiting, constipation, sedation, respiratory depression, and physical dependence.
Therefore, there is an unmet treatment need
for the majority of patients with postoperative pain.
TRV130 is an μ opioid agonist discovered and developed in the United States by Trevena, a novel small molecule G protein-biased ligand that acts on μ-opioid receptors (MOR) for the treatment of moderate to severe acute pain in adult patients requiring intravenous opioids, and has been granted breakthrough therapy designation
by the US FDA.
Enhua Pharmaceutical introduced TRV130 and has exclusive licensing rights
to develop and commercialize TRV-130 in China.
Enhua Pharmaceutical submitted an NDA in China at 1M22, and if the product is successfully launched now, it is expected to become the company's first approved Class 1 new drug, which also means that the company has entered the innovative drug cycle
.
The industry believes that the product is expected to resonate synergistically with the existing fentanyl series products, and the peak sales are expected to exceed 2 billion yuan, reaching 2-3 billion yuan
.
The company is an enterprise focusing on the production, research and development and sales of
central nervous system drugs.
The company is unique in the segment of the market
.
Some listed companies have similarities
between the products of individual categories and the company's products.
According to the 2021 annual report, Enhua Pharmaceutical currently has more than 70 scientific research projects under research, and invested a total of 402 million yuan in scientific research funds in 2021, an increase of 50.
89%
over the previous year.
Among them, in terms of innovative drug research and development, the company has more than 20 innovative drug projects under development; In the research and development and consistency evaluation of key generic drug products, 20 consistency evaluation projects have been carried out; Obtained 3 generic drug production approvals; Generic drugs are under review in 4 projects
.
According to the third quarterly report of 2022, the company achieved operating income of 3.
120 billion yuan from January to September 2022, a year-on-year increase of 7.
89%, and the net profit attributable to shareholders of listed companies was 742 million yuan, a year-on-year increase of 10.
25%, and earnings per share were 0.
7363 yuan
.
At the same time, the company also released the 2022 annual performance forecast, which is expected to be from January 1, 2022 to December 31, 2022: net profit of 837.
66 million yuan to 997.
21 million yuan, an increase of 5% to 25%, and the performance of the same period of the previous year: net profit of 797.
77 million yuan
.
As for the reasons for the change in the annual results of 2022, the company said that it was mainly due to the increase in
the company's main business income.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.