On November 6, Haichen Pharmaceutical (300584) announced that it has received approval for the addition of a new specification for injection of Labetalol Hydrochloride 150mg through a supplemental drug application. The company recently received a notification from the National Medical Products Administration, approving the addition of the 150mg specification based on the already approved 50mg specification, and is considered to have passed the consistency evaluation.

The registration classification of this approval is for chemical drugs, with the manufacturing enterprise being the company itself. The approval number is H20247263. The addition of the new specification will involve changes to the production process, which must be implemented within six months from the date of approval.

Labetalol Hydrochloride injection is a novel ultra-short-acting beta-blocker, clinically suitable for the emergency treatment of various rapid cardiac arrhythmias. In 2023, this product generated sales revenue of 267 million yuan, accounting for 51.59% of the company's total income. The approval of the new specification is expected to further enhance the company's competitiveness and brand effect in the market.

In the first three quarters of 2024, Haichen Pharmaceutical achieved a revenue of 360 million yuan, with a net profit attributable to the parent company of 28.12 million yuan.

https://finance.eastmoney.com/a/202411063231171844.html