Qilu Pharmaceutical Achieves Major Milestone: 99 Products Pass Consistency Evaluation, 42 as First-in-China

　　【Pharmaceutical Network Industry DynamicsRecently, it was announced that Qilu Pharmaceutical's supplemental application for the consistency evaluation of Oseltamivir Phosphate Capsules has been approved by the National Medical Products Administration, indicating that the product has passed the consistency evaluation.
 

Oseltamivir is a potent and highly selective neuraminidase inhibitor that reduces viral dissemination by inhibiting the release of the virus from infected cells, effectively preventing influenza and alleviating symptoms. Data from the MiNe Network shows that in 2020, the sales of oseltamivir in Chinese public medical institutions, including urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions), exceeded 2.7 billion yuan.
 

The original research enterprise of this product is Roche. In China, seven companies already have the production approval for oseltamivir phosphate capsules, including Dongyangguang Pharmaceutical, Breas Pharma, Shanghai Pharmaceuticals Zhongxi Pharmaceutical, CSPC, Kelun Pharmaceuticals, and Betta Pharmaceuticals, etc. Moreover, all these seven companies’ products have passed/been deemed to pass the consistency evaluation. Additionally, more than ten companies’ listing applications are still under review.
 

It is reported that oseltamivir oral conventional release formulations are also included in the seventh batch of bulk procurement. The smooth approval of this variety by Qilu Pharmaceutical will be regarded as passing the evaluation, which means obtaining the qualification for bulk procurement.
 

Recently, Qilu Pharmaceutical has been receiving good news in terms of consistency evaluation. In addition to the Oseltamivir Phosphate Capsules, not long ago, the company’s supplementary application for the consistency evaluation of a new specification of Docetaxel Injection was approved. Clinically, this drug is mainly used for the treatment of advanced or metastatic breast cancer that has failed prior chemotherapy, as well as advanced or metastatic non-small cell lung cancer that has failed cisplatin-based chemotherapy. Currently, the evaluated specifications of this product include single-bottle packages of 1ml:20mg and 4ml:80mg, and double-bottle packages of 0.5ml:20mg and 1ml:40mg. With the enrichment of product specifications, more clinical medication options will be provided to patients.
 

Data from Menet shows that in recent years, the sales of Docetaxel Injection in China's public medical institutions have exceeded 4 billion yuan. Currently, more than 20 companies are competing in this market segment. Regarding consistency evaluation, manufacturers in the domestic market whose Docetaxel Injection has passed the consistency evaluation (or is deemed to have passed the consistency evaluation) include Hengrui Medicine, Huiyu Pharmaceutical, Zhengdatianqing, Qilu Pharmaceutical, Yangzijiang Pharmaceutical, Meidakang Jiale Pharmaceutical, and Aosaikang, among others. In the fifth round of centralized national drug procurement in China, Docetaxel Injection products from Hengrui Medicine, Qilu Pharmaceutical, Zhengdatianqing, Yangzijiang Pharmaceutical, and four other pharmaceutical companies were successfully selected, with price reductions exceeding 90%, while the original research company, Sanofi, was eliminated.
 

In addition, at the end of March, the supplemental application for the consistency evaluation of Qilu Pharmaceutical's Carvedilol Tablets was approved by the National Medical Products Administration, indicating that this product is the first in China to pass the consistency evaluation. Carvedilol Tablets are a neurohumoral antagonist with multiple actions, clinically used for treating essential hypertension and symptomatic congestive heart failure. It has currently been included in the Class B of the National Medical Insurance Catalog. More than 10 companies in China hold the production approval for Carvedilol Tablets. Data from MiNe Network shows that the product’s sales in Chinese public medical institutions exceeded 100 million yuan in 2020, with Qilu Pharmaceutical accounting for 70% of the market. At present, only Qilu Pharmaceutical’s Carvedilol Tablets have successfully passed the evaluation, which will help consolidate its existing market.
 

According to industry statistics, up to now, Qilu Pharmaceutical has cumulatively had 99 products pass the consistency evaluation, of which 42 are the first in China.
 

Disclaimer: In any case, the information or opinions expressed in this article do not constitute investment advice for any person.