Haisco is out!

Recently, Haisco’s R&D pipeline has frequently appeared: the first imitation perindopril indapamide tablet was approved for marketing, the new class 1 drug HSK16149 capsules and HSK21542 injection were approved for new indications for phase II clinical trials.

16 innovative drugs are under development, and 4 new class 1 drugs will be submitted for production

Since 2012, Haisco, whose original main business was the production and sales of enteral nutrition solutions and other related products, has begun to build its own innovative drug team for transformation and innovation, and in 2019 began to explore the internationalization of innovative drugs

As a cutting-edge domestic innovative drug, in recent years, Haisco has increased its R&D investment year by year.

Innovative drugs are gradually entering the harvest period

In addition to cyclopofol, Haisco currently has 9 innovative drugs in the clinical application and above stage, of which 6 are new class 1 drugs involving therapeutic targets such as kappa, DPP-4, BTK-PROTAC, etc.

Some of Haisco's domestic new drugs are under development

Source: China Drug Clinical Trial Publicity Library of Meinenet

Four new class 1 drugs will be submitted for production one after another

It is worth mentioning that HSK29116 powder is the first oral Protac small-molecule anti-tumor drug targeting BTK in China to enter the clinic.

From the perspective of international progress, the phase III clinical trial of cyclopofol emulsion injection in the United States has been approved by the FDA, and it is expected to submit NDA by the end of 2022.

In addition, Hisco's many products have the potential for license-out, and gradually grow into a global innovative pharmaceutical company.

This year won two major imitations, 7 varieties were the first imitations, and the first to be reviewed

On July 27, Haisco announced that the company's 4 types of generic drug perindopril indapamide tablets were approved for production and deemed to have been reviewed, which was the first imitation + first review in China

At present, Haisco has 16 varieties that have passed or deemed to have passed the consistency evaluation.

Haisco's review situation

Source: Meinenet MED2.

The first/exclusive review of 7 varieties, of which perindopril indapamide tablets, avanafil tablets, flupentixol and melitrazin tablets are the first imitation + first review

Among the varieties under review, 5 varieties have submitted supplementary applications for consistency evaluation.

Consistency evaluation varieties under review by Haisco (including new classifications for production)

Source: Meinenet MED2.

Six varieties have won the bid for national centralized procurement, and these varieties are ready to go

In addition to R&D, innovation and internationalization, Haisco also actively embraces national centralized procurement and trades generic drugs with small profits but quicker sales in exchange for more room for growth in innovative drugs in the future

In the five batches and six rounds of national centralized procurement that have been carried out, Haisco has successfully won the bid for six varieties
.
According to data from Meinenet, in the terminal competition pattern of China's public medical institutions in 2020, except for fatty milk amino acid (17) glucose (11%) injection, Haisco's market share in the remaining five varieties is less than 1%
.

Bid-winning status of Haisco National Procurement (unit: yuan/piece, bottle, bag)

Source: Shanghai Sunshine Pharmaceutical Purchasing Network

Among the varieties that have been reviewed, methylprednisolone sodium succinate for injection, medium and long-chain fat emulsion/amino acid (16)/glucose (16%) injection, avanafil tablets, flupentixol and melitroxin tablets It has not yet been included in centralized procurement, except for avanafil tablets, all other varieties have met the requirements for centralized procurement (the number of competing manufacturers reaches 3 or more)
.

Source: Mynet database, public company announcements, etc.

Note: The statistics are as of August 16, if there are any omissions, please correct me!