Huahai broke out! FDA warning letter closes, wins 5 blockbuster varieties and 10 innovative drugs

Recently, Huahai Pharmaceuticals announced heavy news: the southern Sichuan API base warning has been lifted, and sales in the US market are expected to resume
.

At the same time, the two departments issued documents to encourage the upgrading of the API industry, and the API industry is expected to usher in a release period

South Sichuan API base warning is lifted! Positive policies for APIs

South Sichuan API base warning is lifted! Positive policies for APIs

On November 8, Huahai Pharmaceuticals issued an announcement stating that the company recently received a notification letter from the US FDA regarding the closure of the warning letter, stating that the FDA has completed the review of the company’s rectification measures submitted in response to the warning letter.
Based on the review results, the FDA believes that the company The related issues mentioned in the warning letter have been resolved
.

The above warning letter mainly covers the southern Sichuan API production base of Huahai Pharmaceutical, involving 29 API products

After the U.
S.
import ban in September 2018, the API products produced by Huahai Pharmaceutical's Linhai South Sichuan production base and the preparation products made from APIs produced at the South Sichuan production base were not exported to the United States
.

As a result, the company's sales of raw materials have declined, and the market share of major sartan preparations and some neurological preparations such as duloxetine hydrochloride capsules has also declined significantly

Huahai Pharmaceuticals stated that the FDA’s warning letter for closing the company’s southern Sichuan API production base will help the company’s lifting of the ban on the US market and the gradual recovery of sales.
At the same time, it will play a positive role in the company’s new product approval and benefit Boost the company's performance
.

On November 9, the National Development and Reform Commission and the Ministry of Industry and Information Technology issued the "Notice on the Implementation Plan for Promoting the High-quality Development of the API Industry"
.

The plan proposes to vigorously develop characteristic APIs and innovative APIs, increase the proportion of new products and high value-added products; promote the large-scale and intensive development of API production, encourage superior enterprises to become bigger and stronger, and increase industrial concentration; by 2025 Cultivate a group of leading companies with international competitiveness, create a group of industrial clusters and production bases with global influence; guide the development of new business formats such as specialized contract R&D and production services in the field of APIs

Huahai Pharmaceutical is a leading domestic API company and a leader in the export of domestic APIs
.

The promulgation of the plan will further increase the concentration of the API industry, which is conducive to the development of integrated API preparation enterprises such as Huahai Pharmaceutical

28 varieties have been reviewed! 18 new products on the road

28 varieties have been reviewed! 18 new products on the road

Since the beginning of this year, Huahai Pharmaceutical has produced 5 varieties in batches, including pregabalin capsules, valsartan and amlodipine tablets, memantine hydrochloride tablets, rivaroxaban tablets and topiramate tablets
.

Among them, topiramate tablets are the first domestic imitation + first review

Up to now, Huahai Pharmaceutical has 28 varieties (53 acceptance numbers) passed/deemed to pass the consistency evaluation, of which 16 varieties are the first to pass the evaluation
.

The 28 varieties cover 4 treatment categories, of which 14 are neurological drugs, 9 are cardiovascular drugs, and 4 are anti-infective drugs for systemic use

Huahai Pharmaceutical passed/deemed passed consistency evaluation varieties

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

As the leading exporter of APIs and preparations, Huahai Pharmaceutical's previous domestic preparations business foundation was weak, and large-scale procurement has ushered in historic development opportunities for the company's domestic preparations business
.

Among the five batches of centralized procurement that have been implemented, Huahai Pharmaceutical has selected 15 products in total.
The successful bid for centralized procurement has promoted the company's domestic preparation business sales growth
.

In addition, Huahai Pharmaceutical has 18 varieties (29 acceptance numbers) of generic drugs reported for production under the new classification, and they will be deemed to have passed the consistency evaluation after being approved for production
.

From the perspective of the treatment field, there are 6 cardiovascular system drugs and 5 neurological drugs

The new registration classification of generic drugs under review by Huahai Pharmaceutical

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

Accelerate innovation and transformation! 10 innovative drugs to force

Accelerate innovation and transformation! 10 innovative drugs to force

In the short term, mass procurement will help Huahai Pharmaceutical's products with a low market share to quickly open the market, but in the long term, the profit margin of generic drugs is shrinking, and innovation is the core competitiveness of domestic pharmaceutical companies in the future
.
Huahai Pharmaceutical has been continuously improving its R&D and innovation capabilities, accelerating the development of biomedicine and innovative drugs
.

Huahai Pharmaceutical is mainly researching innovative drugs

Source: Minet.
com database, company announcement

In addition to drugs in preclinical research, Huahai Pharmaceutical (including subsidiaries Huaaotai and Huabo Biology) have 10 innovative drugs in the clinical stage
.
Among them, there are 7 class 1 innovative drugs and 3 class 2 improved new drugs
.
From the perspective of drug types, biological drugs are the focus of Huahai Pharmaceutical
.

Subsidiaries Huaaotai and Huabo Biology focus on the research and development of new biological drugs in the fields of tumors, autoimmune diseases and ophthalmological diseases, covering drug research and development fields such as monoclonal antibodies, double antibodies, fusion proteins and ADCs, with more than 20 research projects in progress
.
Among them, the first class new drug HB002.
1M, the second class new drug HOT-3010 and HOT-1010 are already in the phase III clinical stage
.
HOT-3010 and HOT-1010 are expected to be approved for listing at the end of 2022 and early 2023
.