Hengrui Medicine's 76 new class 1 new drugs, 15 varieties, are the first to imitate 20 varieties, and the first to be reviewed

Recently, the "innovative drug brother" Hengrui Pharmaceuticals has been enthusiastic.
First, the stock price fell after the disclosure of the interim report, which caused heated discussions, and then the introduction of two innovative drugs has attracted much attention
.
Focusing on innovation and internationalization, Hengrui Pharmaceuticals has opened the era of "self-research + BD" dual-engine driving.

"Self-developed + BD" dual-engine drive, 76 new class 1 drug screens

In the past two weeks, Hengrui Medicine has reached two innovative drug cooperation agreements
.
The first is to make a 100 million yuan equity investment in Dalian Wanchun, and pay a total of not more than 1.

In the past, Hengrui Pharmaceuticals focused on internal R&D behind closed doors, and seldom used foreign investment and BD to rapidly expand pipelines
.
Two new drug cooperation agreements reached in the past two weeks means that Hengrui Medicine has entered the era of "self-research + BD" dual-engine drive

According to data from Minai.
com, including new drugs introduced through cooperation, Hengrui Medicine currently has 103 innovative drugs (excluding new indications for the development of new drugs already on the market) in the clinical application and above stage, of which 76 are Class 1 new drugs
.

From the perspective of R&D progress, 7 new drugs have been declared for marketing (the highest R&D progress, the same below), of which 4 are Class 1 new drugs; 17 new drugs have entered Phase III clinical trials (including Phase II/III), of which 13 are Class 1 New medicine
.

Hengrui Medicine focuses on researching new drugs

Source: China Drug Clinical Trial Publicity Library of Meinenet

In terms of targets, Hengrui Pharmaceuticals has deployed global popular targets and cutting-edge therapies, such as PD-1/PD-L1, BTK, CDK4/6, ADC, JAK, etc.
; in addition, multiple drugs do not have the same target at home and abroad.
point approved products, including IL-17 monoclonal antibody, a fully human monoclonal antibody OX40, Toll like bodies immune agonists, selective inhibitors FXIA, the GNRH receptor antagonists, A2AR inhibitors, inhibitors of ROMK
.

From the perspective of treatment categories, 103 innovative drugs cover more than a dozen treatment categories, focusing on anti-tumor, nervous system (pain, depression, Parkinson, etc.
), digestive system (type 2 diabetes) and other therapeutic areas.
Among them, anti-tumor drugs are exclusive Nearly "half of the country"
.

In the field of anti-tumor, SHR6390 tablets (CDK4/6 selective inhibitor) have been declared for the market, and are expected to become the first domestically produced CDK4/6 inhibitor class 1 new drug; famitinib malate capsules (multi-target tyrosine kinase inhibitor) ), SHR3680 tablets (androgen receptor antagonist), SHR-1316 injection (PD-L1 monoclonal antibody) and other Class 1 new drugs are undergoing phase III clinical trials, and the research and development progress is ahead of other domestic companies in research
.

In the field of digestive system and metabolism, two oral hypoglycemic drugs proline Henggligliflozin tablets (SGLT-2 inhibitor) and repagliptin phosphate tablets (DPP4 inhibitor) have been declared for the market, and are expected to become the first domestic SGLT -2 inhibitors and DPP-4 inhibitor class 1 new drugs; Noliglycopeptide injection (GLP-1 receptor agonist) type 2 diabetes indication has completed phase II clinical trials, and the obesity indications are in phase II clinical trials; Effective insulin INS068 injection is currently undergoing phase II clinical trials for the treatment of type 2 diabetes
.

In the field of nervous system, two new class 1 drugs for postoperative pain, SHR0410 injection (selective KAPPA opioid receptor agonist) and SHR8554 injection (MOR bias agonist) have entered phase III or phase II/III Key clinical: SHR-1707 injection (anti-β-amyloid antibody) is in phase I clinical for the treatment of Alzheimer's disease
.

In the field of musculoskeletal system, SHR0302 tablets (selective inhibitors of JAK1 kinase) are undergoing phase III clinical trials and are expected to become the first selective inhibitor of AK1 kinase in China; SHR4640 tablets (selective inhibitors of URAT1) are undergoing phase III clinical trials.
For primary gout with hyperuricemia, it is expected to become the first domestically produced Class 1 new drug for the treatment of gout
.

In terms of internationalization, the company has a number of innovative drugs that have carried out phase III clinical trials overseas, including carrelizumab (U.
S.
, Europe), pyrrotinib (U.
S.
, Europe), fluzoparib (U.
S.
), and SHR3680 (Europe), SHR0302 (United States, Europe, Canada) and so on
.

In addition, some new medicines achieved outside permission rights, comprising PD-1 mAb (SHR-1210), BTK inhibitors (SHR-1459, SHR-1266 ), pyrrole erlotinib, SHR-1701 and the like
.

15 kinds of sprint for the first imitation, 12 first/exclusive production

Although Hengrui Medicine puts its main energy, financial resources and manpower on innovative drug development and internationalization, it is also the company's development strategy to imitate high-profit products that have not been imitated, including high-end preparations and first generic drugs
.

According to data from Meinenet, since 2021, the company has 11 generic drugs (including new indications) approved for listing, of which 4 are the first generics, namely dexmedetomidine hydrochloride and sodium chloride injection, tolvaptan Tablets, Azilsartan tablets and Mycophenolate sodium enteric-coated tablets
.

At present, Hengrui Pharmaceuticals has 21 generic drugs under review under the new classification, and 15 of them have not been approved for the first imitation (including the first imitation of the dosage form)
.

In terms of dosage form, in addition to conventional oral dosage forms and injections, the company also has a layout in high-end preparations such as inhalants, liposomes, and oral membranes
.

Hengrui Pharmaceutical's new classification is reported for production and there is no first approved product for imitation

Note: with * is the first/exclusive production

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

12 varieties are produced by Hengrui Medicine's first/exclusive new classification, including bupivacaine liposome injection, tacrolimus sustained-release capsules, phenylephrine ketorolac solution, and diquafox sodium eye drops, ophthalmic tafluprost, indacaterol maleate powder inhalation, injection, etc.
gadobutrol
.

The former "medical stock brother", behind the sharp drop in Hengrui's share price

For many years, Hengrui Pharmaceuticals has been regarded as the "big brother of pharmaceutical stocks", and its market value once exceeded 600 billion yuan, but now, this dominance has been robbed by Mindray Medical
.
As of the close of September 7, Hengrui Medicine reported 48.

In the first half of 2021 alone, Hengrui Pharmaceuticals suffered multiple stock price drops, including the failure of the fifth batch of centralized procurement in June and the failure of the core product iodixanol; the threshold for oncology drug research and development was raised in early July, which caused the company Bad strikes and so on
.
The most recent incident occurred on the second day after the publication of the Interim Report, and it was the first time in nearly 5 years that the limit was directly blocked

On August 19, Hengrui Medicine released the 2021 H1 performance report
.
During the reporting period, the company achieved operating income of 13.

There are two main reasons for the performance lower than market expectations: one is the decline in sales of traditional generic drugs due to the impact of centralized procurement, which puts greater pressure on the company’s performance; Price cuts + difficulty in entering the hospital dragged down, and revenue grew negatively from the previous month during the reporting period
.

Under the action of the three-medicine linkage series of policies, the decline in the performance of generic drugs and the decline in stock prices may not be unique to Hengrui Pharmaceuticals.
It is the "throttle" of pharmaceutical companies dominated by generic drugs in the process of transforming to R&D and innovation.
When the life cycle of a new product is over, whether it is performance or stock price, it will usher in a new round of take-off
.

For Hengrui Medicine, currently 43 varieties of the company have passed or deemed to have passed the consistency evaluation (20 are the first ones), 30 of which have been included in the national centralized procurement, and 18 have won the bid, an average decrease of 72.
6%
.
A number of core generic drug products have been included in centralized procurement, including docetaxel, cisatracurium, dexmedetomidine, iodixanol, etc.

On the other hand, the proportion of Hengrui Pharmaceutical’s innovative drug revenue has increased from 14% in 2018 to nearly 40% of H1 in 2021.

Source: Mi Nei.

Note: The review data statistics are as of September 6, if there are any omissions, please correct me!