Huahai is up!

　　Recently, there has been good news from Huahai Pharmaceuticals.
The Class 1 new drug HB0036 has been approved for clinical use, the antidepressant ANDA has been approved by the FDA, and Pfizer's new crown oral drug order has been won.
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At present, Huahai Pharmaceutical has 15 innovative drugs (12 Class 1 new drugs) Among them, 2 new drugs are in phase III clinical stage and are expected to be marketed; 38 varieties have been reviewed (15 first), and a total of 18 varieties have won bids for national centralized procurement; 26 new categories of reported products are under review, of which 3 No first imitation (including first imitation of dosage form) has been approved yet
.
Won 8 heavyweight varieties, 38 over-reviewed varieties were dazzling On August 12, the official website of the State Food and Drug Administration showed that Huahai Pharmaceutical's 4 generic drugs duloxetine hydrochloride enteric-coated capsules and sitagliptin phosphate tablets Approved for production and deemed to have been reviewed
.
According to data from Minet.
com, in 2021, the sales of terminal duloxetine and sitagliptin in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) will exceed 900 million yuan and 18 million yuan respectively.
billion
.
Since the beginning of this year, Huahai Pharmaceutical has approved the production of 8 newly registered and classified generic drugs and considered them to be reviewed, covering the fields of neuropsychiatry, metabolism, cardiovascular and cerebrovascular, and anti-infection, further enriching the company's product pipeline
.
Among them, the terminal sales of sitagliptin phosphate tablets, losartan potassium hydrochlorothiazide tablets, and levetiracetam injection concentrated solution will all exceed 1 billion yuan in Chinese public medical institutions in 2021; oseltamivir phosphate capsules will be sold in July It was approved for listing on the 7th, successfully caught up with the last train of the seventh batch of centralized procurement and obtained the qualification to be selected
.
Generic drugs approved for production by Huahai Pharmaceutical from 2022 to the present As of now, Huahai Pharmaceutical has 38 varieties that have passed/deemed to have passed the consistency evaluation, and a total of 18 varieties have been selected in the six batches of centralized procurement of chemical drugs carried out by the country
.
Among the 38 varieties, 15 varieties were first reviewed, 1 was technology transfer from the original research; 3 varieties, including lisinopril tablets, fosinopril sodium tablets, and nevirapine tablets, were exclusively reviewed
.
In terms of dosage form, Huahai Pharmaceutical's over-rated varieties are mainly tablets, accounting for 86.
84%
.
Huahai Pharmaceutical passed/deemed to pass the consistency evaluation varieties From the perspective of therapeutic areas, 38 varieties involved 6 major therapeutic areas, mainly concentrated in nervous system drugs (17), cardiovascular and cerebrovascular drugs (11), systemic drugs Anti-infectives (5)
.
According to data from Minet.
com, in 2021, the sales volume of terminal systemic anti-infective drugs in China's public medical institutions will exceed 150 billion yuan, and the sales of cardiovascular and cerebrovascular drugs and nervous system drugs will both exceed 100 billion yuan
.
12 Class 1 new drugs are eye-catching, and 26 new products are on the way.
On August 19, Huahai Pharmaceutical announced that the Class 1 biological drug HB0036 injection has obtained the implied license for clinical trials, and the indication is advanced solid tumors
.
HB0036 is a bispecific antibody targeting PD-L1 and TIGIT, which can simultaneously bind to PD-L1 and TIGIT with high specificity, block the immunosuppression mediated by the two, and reactivate the immune system The killing of tumor cells finally achieves a synergistic anti-tumor effect
.
At present, there are no similar drugs targeting the above two pathways on the market at home and abroad
.
From 2022 to now, Huahai Pharmaceutical has had 4 Type 1 new drugs approved for clinical use in China, including HB0036 injection, HB0034 injection, HB0028 injection, and HHT120 capsule
.
In addition, HB0036 was approved by the US FDA for clinical research in January this year, and is currently conducting Phase I clinical research in the United States
.
At present, Huahai Pharmaceutical has 15 innovative drugs under development, focusing on cardiovascular and cerebrovascular, tumor, autoimmunity and other fields, of which there are 12 category 1 new drugs
.
Among the 15 innovative drugs, two biosimilars, HOT-3010 and HOT-1010, are in phase III clinical stage and are expected to be marketed; HB002.
1M and HHT-101, two class 1 new drugs, are in phase II clinical stage, and the remaining innovative drugs are clinically Research continues
.
Huahai Pharmaceutical is mainly researching innovative drugs In terms of generic drugs, Huahai Pharmaceutical currently has 26 new registration and classification applications under review, and it will be deemed to have passed the consistency evaluation after being approved for production
.
The 26 varieties cover 8 therapeutic areas, mainly focusing on cardiovascular and cerebrovascular drugs (8), nervous system drugs (7), anti-tumor and immunomodulatory agents (4)
.
Huahai Pharmaceutical's 3 newly registered and classified generic drugs under review have not yet been approved for listing (including the first generic in dosage form), including dopamine tablets, olanzapine fluoxetine capsules, dimethyl fumarate intestinal Dissolved capsules
.
According to data from Minet.
com, the sales of Dopaszil tablets from Roche, a public medical institution in China, will exceed 800 million yuan in 2021, a year-on-year increase of 10.
20%; in fiscal 2021, the global sales of Bojian's dimethyl fumarate will exceed 2 billion US dollars.

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On August 19, Huahai Pharmaceutical announced that the ANDA of the antidepressant levomilnacipran sustained-release capsules declared by the company to the US FDA has been provisionally approved
.
Levomilnacipran Sustained-Release Capsules is an antidepressant.
At present, there is no original research drug or generic drug application for listing in the domestic market.
If the product of Huahai Pharmaceutical is transferred to China as an ANDA in the United States, the listing process can be accelerated
.
It is worth mentioning that Huahai Pharmaceutical has obtained 18 ANDA numbers (including provisional approval) in the United States since the beginning of this year, focusing on the fields of neuropsychiatry and chronic diseases
.
At present, Huahai Pharmaceutical has 86 US ANDA numbers, which is conducive to the company's continuous expansion of sales in the US market, strengthening the product supply chain, enriching the product echelon, and enhancing the market competitiveness of the company's products
.
Huahai Pharmaceutical's ANDA Approval in the U.
S.
from 2022 to Present Advantages, not only leading domestic pharmaceutical companies in the field of preparation export and international development, but also recognized by global pharmaceutical giants
.
On August 18, Huahai Pharmaceutical announced that the company and Pfizer signed the "Master Production and Supply Agreement", and Huahai Pharmaceutical will provide preparations for the new coronavirus treatment drug Paxlovid sold by Pfizer in the Chinese mainland market during the agreement period (5 years).
Outsourced production services
.
Pfizer provides the raw materials for nematevir and ritonavir preparations, and Huahai Pharmaceutical is responsible for the production of nematevir preparations and completes the combined packaging
.
As early as March this year, Huahai Pharmaceutical has obtained the MPP authorization of Pfizer's new crown oral drug, which can simultaneously produce Paxlovid's APIs and preparations
.
The acquisition of Pfizer's localized production order is an important milestone for Huahai Pharmaceutical to enter the CMO/CDMO track
.
Data source: Minet database, company announcement Note: Minet's "Competitive Landscape of Public Medical Institutions in China", 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 in the terminal
.
The statistics are as of August 22.
If there are any omissions, please correct me! Won 8 blockbuster products, 38 over-reviewed products, 12 class 1 new drugs, 26 new products on the road , 18 ANDA numbers, won the Pfizer new crown oral drug order enterprise hospital