The first class 1 new cerebrovascular Chinese medicine is declared for production!

In this issue (October 29 to November 5), the number of approved new drugs for category 2 has increased rapidly, and the battle for PD-1 monoclonal antibody indications has intensified.
Henan Tianfang Pharmaceutical Industry Naoshang Lesheng Granules is again reported for production.
More developments are as follows :

Domestic Review and Approval·New Trends

Domestic Review and Approval·New Trends

This week, CDE has 47 acceptance numbers (36 varieties) reported to the production processing status update.
Among them, Sichuan Jianneng Pharmaceutical's sodium phosphate powder has attracted much attention.
More developments are as follows:

Data source: Yaozhi data

Jianneng Pharmaceutical's Class 2.
2 new drug was approved for listing

Jianneng Pharmaceutical's Class 2.
2 new drug was approved for listing

Sichuan Jianneng Pharmaceutical's self-developed 2.
2 new drug-sodium phosphate powder was approved by NMPA for marketing
.

Sodium phosphate is used for colon X-rays and intestinal endoscopy or to clean the intestines before surgery
.

Previously, sodium phosphate salt was marketed as oral solution and tablet

Domestic review and approval, new acceptance

Domestic review and approval, new acceptance

CDE added 38 new production acceptance numbers this week, with a total of 33 varieties, including Hengrui Medicine’s SHR3680 tablets, Cinda Bio’s Sintilimab injection, Henan Tianfang Pharmaceutical’s Brainshang Lesheng Granules, and Xi’an Yangsen’s Rilpivirin injection has attracted much attention.
See the table below for more developments:

Data source: Yaozhi data

Hengrui's second-generation AR inhibitor SHR3680 first applied for listing

Hengrui's second-generation AR inhibitor SHR3680 first applied for listing

Recently, Hengrui Medicine's independent research and development of the SHR3680 tablet marketing authorization application was accepted by the National Medical Products Administration.
The proposed indication is: high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC), which was approved by the National Medical Products Administration Center for Drug Evaluation Included in the public list of varieties to be reviewed first
.

Previously, SHR3680 tablets were also included as a breakthrough treatment product by the Drug Evaluation Center of the State Drug Administration

SHR3680 is a second-generation AR inhibitor with independent intellectual property rights developed by Hengrui Medicine.
Compared with the first-generation AR inhibitor, SHR3680 has a stronger AR inhibitory effect and no agonistic effect
.

In 2018, SHR3680 was supported by the major new drug creation project of the Ministry of Science and Technology

First-line gastric cancer! Cinda Bio's PD-1 7th indication was declared and listed

First-line gastric cancer! Cinda Bio's PD-1 7th indication was declared and listed

On November 4, Innovent's PD-1 inhibitor Daboshu® (sintilimab injection) combined with chemotherapy (oxaliplatin + capecitabine) first-line treatment of unresectable locally advanced and recurrent unresectable Or metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJ) new indications for marketing applications have been accepted
.

Gastric cancer is one of the most common malignant tumors in the world, and half of the cases occur in East Asia, mainly in China
.

Currently in China, only the imported PD-1 nivolumab has been approved for the first-line gastric cancer indication, and Cinda is the first domestically produced PD-1 to declare this indication

Sintilimab is an innovative PD-1 inhibitor drug of international quality jointly developed by Cinda Biopharmaceuticals and Eli Lilly.
It has been approved for four indications in China, including Hodgkin’s lymphoma, non-squamous NSCLC, squamous NSCLC, and hepatocellular carcinoma

In addition, two other indications have been submitted for marketing applications and are currently in the review and approval stage.
They are the second-line treatment of squamous NSCLC and the combined chemotherapy for the first-line treatment of esophageal squamous cell carcinoma
.

Sintilimab has successfully entered China's National Medical Insurance List in November 2019, and is the first PD-1 inhibitor in the country to enter the National Medical Insurance List

Data source: Yaozhi data

Currently, domestic PD-1 competition is extremely fierce
.

According to the third-quarter financial reports released by various pharmaceutical companies, the growth of domestic PD-1 sales has slowed

Johnson & Johnson's new anti-HIV drug "Rilpivirin Injection" is reported for production in China

Johnson & Johnson's new anti-HIV drug "Rilpivirin Injection" is reported for production in China

Yaozhi data shows that the application for listing of the new AIDS drug Ripavirin injection submitted by Xi'an Janssen Company has been accepted
.

Previously, rilpivirin tablets have been approved in China for use in combination with other anti-HIV drugs for the treatment of adult human immunodeficiency virus type 1 (HIV-1) infection

It is reported that Rilpivirin is a small oral non-nucleoside reverse transcriptase inhibitor (NNRTI), which has the characteristics of definite efficacy, safety and well tolerability
.

In addition to the single drug, a number of "cocktail therapy" consisting of rilpivirin and other HIV therapies have also received regulatory approvals

Naoshang Lesheng Granules, a new class 1 traditional Chinese medicine, has been declared and launched!

Naoshang Lesheng Granules, a new class 1 traditional Chinese medicine, has been declared and launched!

Yaozhi data shows that the listing application of the new class 1.
1 Chinese medicine "Naoshang Lesheng Granules" has been accepted by CDE.
This is the first class 1 new cerebrovascular Chinese patent medicine to be produced in China
.

Public information shows that Naoshang Lesheng Granule is a new Chinese medicine developed by Henan Tianfang Pharmaceutical under China National Pharmaceutical Co.
, Ltd.
and Shenzhen Shasong Industrial Co.
Cerebral trauma and after craniocerebral surgery, the symptoms such as weakness of Qi and blood, damage to the brain and collaterals, stasis and meridian paralysis
.
The drug once submitted a marketing application for Naoshang Lesheng Granules (new drug category 6.
1) to the State Food and Drug Administration in 2013, and was voluntarily withdrawn in 2016.
After a lapse of five years, it resubmitted the marketing application with a new drug category 1.
1
.