"Brother Innovative Drugs" is working hard!

Recently, Hengrui Medicine, known as the "first brother of innovative drugs", has frequently reported: SHR8554 injection submitted a marketing application, and HRS-5965 tablets, HR20014 injection, HRS-4642 injection and other class 1 new drugs were approved for clinical use for the first time

Six blockbuster first imitations were approved, and innovative drugs sold over 11 billion

Recently, Hengrui Medicine has successively issued announcements on the approval of new products: on July 2, its 4 types of generic drug Tacrolimus Sustained-Release Capsules were approved for production and deemed to have been reviewed, which is the first domestic generic + first Reviewed; on June 30, its Class 1 new drug revalutamide tablets was approved for marketing, becoming the first domestically produced new androgen receptor (AR) inhibitor

Based on the date of the review conclusion, since 2022, Hengrui Medicine has 1 category 1 new drug approved for marketing for the first time, and 1 category 1 new drug with new indications; 9 varieties have been approved for production and are deemed to have been reviewed, of which 6 A first imitation

From 2022 to the present, Hengrui Medicine has been approved for listing

Source: MED2.

Among the 6 first imitations, nimodipine oral solution, ondansetron oral dissolving film, tacrolimus sustained-release capsule, and acetaminophen mannitol injection are new dosage forms

Revelutamide is the 11th innovative drug (the 10th Class 1 new drug) approved for marketing by Hengrui Medicine in China, and the first new androgen receptor (AR) inhibitor independently developed by a Chinese company.

According to data from Minet.

Hengrui Medicine has been approved for innovative drugs

Note: unsold or sales less than 100 million yuan are represented by *

Source: Mi intranet database

Of the 11 innovative drugs, 8 have been successfully negotiated into the National Medical Insurance Catalogue, of which apatinib, camrelizumab, fluzoparib, and hetropopa ethanolamine have been included in medical insurance for 2 or more indications

On June 29, 2022, the National Medical Insurance Administration announced the "2022 National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog Adjustment Work Plan" and related documents, marking the official start of a new round of national medical insurance catalog adjustments

128 new drugs under development dominate the market, and 17 new class 1 drugs are expected to be launched

As the "first brother of innovative drugs" in China, Hengrui Medicine is far ahead in the number of innovative drugs under development

Since 2021, in addition to insisting on independent research and development, Hengrui Medicine has also continued to strengthen external cooperation, and has successively reached agreements with companies such as CStone Pharmaceuticals, Tianguangshi, Dalian Wanchun, and French Iktos

According to data from Minet.

From the perspective of research and development progress, 13 new drugs have been/will be declared for marketing (the highest research and development progress, the same below), of which 6 are Category 1 new drugs; 13 new drugs have entered the phase III (including II/III) key clinical trials, of which there are 11 are Class 1 new drugs

Hengrui Medicine's domestic research and development of innovative drugs

Source: Minet China Drug Clinical Trials Publicity Library

From the perspective of indications, Hengrui Medicine's new drugs under development focus on anti-tumor and immunomodulatory agents (tumor, autoimmune diseases), digestive system and metabolic drugs (diabetes, obesity, antiemetics, etc.

Antineoplastic drugs account for over 40%, covering lung cancer, breast cancer, liver cancer, stomach cancer, prostate cancer, colorectal cancer, urothelial cancer, bladder cancer and other sub-diseases; digestive system and metabolic drugs are diabetes drugs as the main Mainly, DPP4, SGLT2, GLP-1 and other popular targets have been deployed, covering small molecule oral drugs and compound preparations, fast-acting insulin, long-acting insulin, etc.

In terms of targets, Hengrui Medicine has deployed global popular targets and cutting-edge processes, such as PD-(L)1, BTK, CDK4/6, ADC, JAK, CD20, etc.

On the PD-(L)1 target, Hengrui Medicine’s camrelizumab has been approved for marketing, and it has become the domestic PD-1 mAb with the most medical insurance indications, and it is still developing combination drugs and Broaden clinical research for new indications
.
In addition, the PD-L1 monoclonal antibody adebelimumab has been reported for production, the PD-L1/TGF-B dual antibody SHR-1701 has entered Phase III clinical trials, and the subcutaneous injection of PD-1 monoclonal antibody SHR-1901 has entered Phase I clinical trials clinical
.

Hengrui Medicine is currently the domestic pharmaceutical company with the largest number of ADC drugs under development.
There are 8 new drugs in the clinical application stage and above.
Among them, the Her2-targeting ADC drug SHR-A1811 has made the fastest progress and is currently undergoing Phase III clinical trials
.
In addition, 6 ADC drugs have entered Phase I clinical trials, and 1 ADC drug is in clinical application
.

60 varieties have been reviewed, and 7 varieties have been imitated for the first time.

On July 26, the official website of the State Food and Drug Administration showed that Hengrui Medicine's lipiodol injection (Papaver B-lipiodol injection) passed the consistency evaluation and was the first in China
.

At present, Hengrui Medicine has 60 varieties reviewed (31 are the first), covering 12 major categories of treatment, focusing on anti-tumor and immunomodulators (13 varieties), nervous system drugs (11 varieties), cardiovascular system Drugs (8 varieties) and other therapeutic fields; dosage forms are widely distributed, in addition to ordinary oral normal-release dosage forms, it also includes injections, sustained and controlled release preparations, inhalants, eye drops, oral dissolving films,
etc.

Review of Hengrui Medicine

Note: with * is the first/exclusive review

Source: MED2.
0 China Drug Evaluation Database

In the face of policy pains, Hengrui Medicine decided to "cut off" some generic drug projects and only make innovative drugs and high-end generic drugs with core value
.
Since 2022, the company has only submitted supplementary applications for consistency evaluation of 3 varieties, and no generic drug has submitted a marketing application
.

At present, Hengrui Medicine has 8 supplementary application varieties for consistency evaluation under review, including Oxaliplatin for Injection, Ringer's Injection Sodium Bicarbonate, Compound Sodium Acetate Ringer's Injection (Sodium Potassium Magnesium Calcium Glucose Injection), Sina injection, rosiglitazone tablets and other varieties have not yet been reviewed by companies
.
Among the newly classified generic drugs (excluding withdrawn or unapproved varieties), 7 of them have not been approved for the first time (including the first copy of the dosage form)
.

Hengrui Pharmaceutical has declared a new classification and has not yet approved the first imitation product

Source: MED2.
0 China Drug Evaluation Database

Cyclophosphamide Capsules, Bupivacaine Liposome Injections, Paricalcitol Soft Capsules, 10% Fat Emulsion (OO)/5.
5% Amino Acids (15)/Glucose (20%) Injections are exclusively by Hengrui Medicine declare
.