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Recently, the research and development of Haisco innovative drugs has made new progress, HSK16149 capsules have been declared for marketing, and the phase II clinical trial of HSK31858 tablets has been ethically approved
.
At present, Haisco has 16 innovative drugs (13 Class 1 new drugs) under development, and 3 Class 1 new drugs can be expected to be launched; Rapid ramp-up of new anesthesia drugs, and parallel license-in/out transactions; 23 varieties have been evaluated (11 are the first in China), 8 varieties have won the bid for national collective procurement, and 3 new classification products are under review
.
13 Class 1 new drugs are under research, aiming at 300 billion markets
On November 8, Haisco issued an announcement that the marketing application of HSK16149 capsules, a class 1 new drug, was accepted by the State Food and Drug Administration and intended to be used for the treatment
of peripheral neuropathic pain.
On November 16, Haisco announced that the phase II clinical trial of HSK31858 tablets of Class 1 new drug has obtained ethical approval, which is intended to be used for the treatment of lower respiratory tract diseases
caused by bronchiectasis and acute lung injury/acute respiratory distress syndrome.
With R&D, production and sales of innovative drugs as its core business, Haisco is committed to becoming the most trusted international innovative drug enterprise
.
In the first half of 2022, Haisco invested 347 million yuan in R&D, a year-on-year increase of 1.
52%, and R&D investment accounted for 27.
82%
of sales revenue.
At present, Haisco has 16 innovative drugs (including 13 in class 1 and 3 in class 2), focusing on anesthesia and analgesia, diabetes and complications, neuralgia and tumors
.
According to data from Minai.
com, in 2021, the sales scale of terminal anti-tumor and immunomodulator, digestive system and metabolite drugs in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) exceeded 170 billion yuan, and the sales scale of nervous system drugs exceeded 100 billion yuan.
The situation of Haisco's main innovative drugs
Source: Minai.
com China Clinical Trial Library, company announcement
The company's innovative R&D pipeline has gradually entered the cashing period, and the α2δ-1 regulator HSK16149 capsules have been declared for marketing; DPP-4 inhibitor HSK7653 tablets and kappa receptor HSK21542 injection are in phase III.
clinical stage; DPP1 inhibitor HSK31858 tablets, FXI inhibitor HSK36273 for injection, HL231 inhalation solution are all in phase II.
clinical stage
.
3 Class 1 new drugs can be expected! HSK16149 capsule can bind to calcium channel α2δ subreceptor, the first indication declared for marketing is diabetic peripheral neuralgia, and the indication of postherpetic neuralgia is in phase III.
clinical stage
.
HSK7653 is a long-acting inhibitor of DPP-4, which is scheduled to file for NDA by the end of 2022 and is expected to become the world's first biweekly formulation of hypoglycemic drugs
.
HSK21542 injection is a peripheral kappa opioid receptor selective agonist with dual effect of analgesia and antipruritic, and is the company's first international fast follow new drug, with development indications including postoperative analgesia, uremic pruritus, liver disease pruritus, etc
.
Cyclopofol sales skyrocket! Won 4 license-in/out deals
Cyclopofol injection is the first Class 1 new drug to enter the commercialization stage of Haisco, and it is also a blockbuster innovative drug in the field of anesthesia, which was included in the 2021 edition of the national medical insurance catalogue
in November 2021.
With the approval for marketing as the "starting point", the indications of cyclopofol injection have continued to expand and steadily advance internationally, and at present, it has been approved for non-tracheal intubation in China for indications such as sedation and anesthesia in surgery/operation, induction and maintenance of general anesthesia, and sedation during intensive care; The phase III clinical study will be carried out directly in the United States, and it is expected to be filed for marketing
by the end of 2023.
With the help of indications expansion and medical insurance, the cyclopofol injection market ushered in rapid volume
.
According to the financial report, the number of cyclopofol sales in the first half of 2022 was about 1.
5 million, and it has entered more than 900 hospitals, of which 55% are hospitals above the top three; Strive to cover about 1,400 hospitals throughout the year, and achieve more than
4 million cyclopofol sales throughout the year.
It is remarkable that the sales of anesthesia products in the first half of the year reached 129 million yuan, a year-on-year increase of 1602.
52%.
In addition to the internationalization of self-developed products, Haisco also actively strengthens business development, accelerating the promotion of R&D projects License-out and License-in since 2021, and optimizing business cooperation to enrich the product pipeline
.
In terms of license-out, the FTP-637 project, a subsidiary of Haisco's overseas holdings, was sold to Foresite Capital for a down payment of US$60 million and a milestone payment of up to US$120 million, demonstrating the company's R&D strength and product internationalization potential
.
FTP-637 is a TYK2 inhibitor, the world's first TYK2 inhibitor approved by the FDA in September 2022 as Bristol-Myers Squibb's deuterated colesitinib
.
In terms of license-in, Haisco has successively introduced olanzapine transdermal patch for vomiting caused by tumor chemotherapy Starton in the United States, Lorecivivint for the long-acting treatment of osteoarthritis by Biosplice in the United States, and riluzole oral membrane
for the treatment of "ALS" by Aquestive in the United States.
At present, no transdermal patch of olanzapine has been approved for marketing
in the world.
According to data from Minai.
com, the sales scale of terminal olanzapine in China's public medical institutions exceeded 2 billion yuan in 2021, a year-on-year increase of 6.
63%; In the first half of 2022, its sales scale exceeded 1 billion yuan, a year-on-year decrease of 9.
66%.
Riluzole is the first ALD drug approved by the FDA, with a terminal sales scale of more than 100 million yuan in China's public medical institutions in 2021, and the domestic marketed preparations include riluzole tablets, riluzole capsules, and riluzole oral suspension
.
23 varieties have been evaluated, and the generic drug pipeline is "shrinking"?
In terms of generic drugs, Haisco has approved 22 first generic drugs for marketing
.
With the company's transformation into innovative drugs, the number of generic drug products under research has gradually decreased
.
So far in 2022, Haisco has only submitted a marketing application for a generic drug of gliclazide sustained-release tablets, which was undertaken by CDE on July 5
.
The company has only 3 newly registered generic drug marketing applications under review, specifically riprodiccaine cream, compound vitamin injection, and gliclazide sustained-release tablets, which will be deemed to have passed the consistency evaluation
after approval for production.
As the number of generic drugs is no longer increased and the collection and digestion of existing varieties is completed, the company's generic drug business will enter a stable state of development
.
At present, 23 varieties of Haisco have passed/deemed to have passed the consistency evaluation
.
Among them, 11 varieties are the first in China to have been evaluated, and 3 varieties such as polyprezinc granules, compound amino acid injection (18AA-VII.
), compound amino acid (18AA)/glucose (15%) electrolyte injection are exclusive reviews
.
Haisco passed/deemed to evaluate varieties through consistency
Source: Minai.
com China Declaration Progress (MED) database
In terms of therapeutic areas, 23 varieties are mainly concentrated in blood and hematopoietic system drugs (7) and systemic anti-infective drugs (5).
According to data from Minai.
com, in 2021, the sales scale of terminal blood and hematopoietic system drugs and systemic anti-infective drugs in China's public medical institutions exceeded 150 billion yuan
.
In the third and fourth batches of centralized procurement carried out by the state, Haisco each won the bid for 3 varieties, and the seventh batch of centralized procurement won the bid for 2 varieties, and a total of 8 varieties won the bid for national centralized procurement
.
Among them, 5 varieties were supplemented by consistency evaluation and 3 varieties were registered for mass production under the new classification and treated as passed
.
In terms of supplementary applications for consistency evaluation, Haisco also has 6 varieties under review, including compound amino acid injection (20AA), caspofungin acetate for injection, compound amino acid injection (18AA-IX.
), fondaparinux sodium injection, rupatadine fumarate tablets, and compound amino acid injection (18AA-VII.
).
Among them, rupatadine fumarate tablets and compound amino acid injection (18AA-IX) were the first to be evaluated
.
Data source: Minainet database, company announcement Note: Minainet "Drug Terminal Competition Pattern of China's Public Medical Institutions", the statistical scope is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics, village clinics; The above sales are calculated
based on the average retail price of the product at the terminal.
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