[Yaokajun] Chinese medicine broke out again!

What to watch this week

Urothelial cancer welcomes its first ADC

A variety of new anti-infective drugs are reported to usher in new progress

BeiGene PD-1 Approved for the 6th Indication

Jianmin Pharmaceutical's Qirui Weishu Capsule was approved for listing

In this issue (January 1st to January 7th), Hengrui Medicine has obtained two innovative drugs, Vidicitumumab and Tislelizumab have been approved for a new indication respectively, and innovative traditional Chinese medicine drugs have once again been approved.
A number of new anti-infective drugs have ushered in new progress due to the outbreak.
More developments are as follows:

Domestic review and approval · new trends

This week, CDE has 51 acceptance numbers (37 varieties) to report the status update of production management.
Among them, Hengrui Medicine's Dalcil, Henggliflozin, Rongchang Bio's Vidicitumumab, BeiGene's Tislelizhu Monoclonal antibody and Jianmin Pharmaceutical's Qirui Weishu Capsules have attracted much attention
.
More updates are as follows:

Data source: Yaozhi Data

Hengrui's two new drugs are approved for marketing

On December 31, the National Medical Products Administration (NMPA) approved the marketing applications of two Class 1 innovative drugs of Hengrui Medicine through the priority review and approval process, namely Dalcilis Isethionate Tablets and Proline Henggliflozin.
clean sheet
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The number of innovative drugs launched by Hengrui Medicine in China has increased to 10, and another 13 innovative drugs have entered clinical phase 3, or are already on the way to market applications

◆ Dalcilis Isethionate Tablets (SHR6390)

Dalsilir is the first CDK4/6 inhibitor originally developed in China.
The approved indication is for hormone receptor (HR) positive and human epidermal growth factor receptor 2 (HER2) negative endocrine therapy in combination with fulvestrant.
Treatment of post-progressed recurrent or metastatic breast cancer
.

In China, four CDK4/6 inhibitors have been approved, namely Pfizer’s pipercell, Eli Lilly’s abexil, Hengrui’s darxili, and Qilu’s generic pipercell (Pfizer’s pipercell) Seely Compound Patent (China) expires on January 10, 2023)
.
In addition, domestic pharmaceutical companies with patent layout "CDK inhibitors" include Shanghai Xunhe Medicine, Chia Tai Tianqing,

This week, Eli Lilly's abeccil was also approved for a new indication in China, in combination with endocrine therapy (tamoxifen or aromatase inhibitor) for hormone receptor (HR) positive, human epidermal growth Adjuvant therapy for adult patients with factor receptor 2 (HER2) negative, lymph node positive, high recurrence risk and Ki-67≥20% early breast cancer, becoming the first and only CDK4 & 6 inhibitor approved in China for early breast cancer patients agent
.
This is also the new indication of Abecili tablets after it was approved by NMPA in December 2020 for the treatment of HR+, HER2- locally advanced or metastatic breast cancer

◆ Proline Henggliflozin Tablets

Henggliflozin is currently the first domestically-made innovative SGLT2 inhibitor approved to improve glycemic control in adults with type 2 diabetes
.
Henggliflozin is also Hengrui Medicine's first listed innovative drug in the field of diabetes

At present, SGLT2 inhibitor products on the market worldwide include AstraZeneca's Dapagliflozin, Johnson & Johnson's Canagliflozin, Boehringer Ingelheim's Empagliflozin, Merck's Egliflozin, Sanofi's Suogliflozin Ggliflozin, Ipagliflozin from Astellas, Topagliflozin from Zhongwai Pharmaceutical and Lupagliflozin from Taisho Pharma
.

Urothelial cancer welcomes its first ADC

Yaozhi data shows that Rongchang Bio's new indication marketing application for vedicitumab for injection has been approved for the treatment of patients who have received platinum-containing chemotherapy and HER2 overexpression, that is, immunohistochemical test results of 2+ or 3+ of patients with locally advanced or metastatic urothelial carcinoma
.
This is the first ADC drug targeting HER2 in the treatment of urothelial carcinoma in China

Vidicitumumab (Aidexi) is an antibody-conjugated drug (ADC) targeting HER2.
In June last year, the drug was first approved in China for use in HER2 patients who have received at least 2 systemic chemotherapy.
The treatment of patients with locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) has become China's first self-developed new antibody-drug conjugate (ADC) drug, which was included in the new National Medical Insurance Catalogue on December 3 of the same year
.
Urothelial carcinoma is the second indication for veldicitumab to be approved for marketing

In August 2021, Seattle Genetics secured an exclusive worldwide (excluding Asia Pacific) license agreement for Veldicitumab for injection for up to $2.
6 billion in upfront and milestone payments and sales royalties
.

BeiGene PD-1 Approved for the 6th Indication

This week, BeiGene's anti-PD-1 antibody tislelizumab received approval for a new indication for the second- or third-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
.
This is the sixth indication for tislelizumab approved in China, and the third indication for lung cancer approved in China, marking that the drug can be used for both first-line, second- or third-line treatment of NSCLC treatment

The approved indications for tislelizumab include:

①Third-line treatment of classic Hodgkin lymphoma

②Urothelial carcinoma

③First-line treatment of advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy

④First-line treatment of advanced non-squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy

⑤ Second-line treatment of hepatocellular carcinoma (HCC)

⑥Second-line or third-line treatment of non-small cell lung cancer"

In addition, the U.
S.
Food and Drug Administration has also accepted a marketing authorization application for Betadine® for the treatment of patients with unresectable, recurrent locally advanced or metastatic ESCC after prior systemic therapy
.
The PDUFA target date is July 12, 2022

In January 2021, Novartis reached a cooperation and licensing agreement with BeiGene, with a total transaction value of US$2.
2 billion, setting a new historical record for the down payment of Chinese new drugs "going overseas"
.

Jianmin Pharmaceutical's Qirui Weishu Capsule was approved for listing

Recently, according to the National Drug Administration, Jianmin Pharmaceutical's 1.
1 class innovative drug Qirui Weishu Capsule was approved for launch
.
The drug is an innovative traditional Chinese medicine drug developed on the basis of preparations in medical institutions.
A randomized, double-blind, positive drug parallel controlled, multi-center clinical trial has been carried out
.
The results of clinical trials show that it can be used for the treatment of epigastric pain caused by mild to moderate chronic non-atrophic gastritis with erosion damp-heat stasis syndrome
.

Two new anti-infective drugs approved for import

◆ Isavuconazole Sulfate Capsules

The drug is a broad-spectrum triazole antifungal drug developed by Pfizer
.
This is the second indication approved in China after the approval of isavuconazole sulfate capsules for invasive mucormycosis
.
At present, isavuconazole has been approved in more than 60 countries and regions including the United States, the United Kingdom, France, and Switzerland
.

◆ Letermovir tablets

The drug is a novel non-nucleoside cytomegalovirus (CMV) inhibitor developed by Merck.
It is the world's first and currently the only drug approved for the prevention of cytomegalovirus infection in allogeneic HSCT recipients
.
It is approved in China for the prevention of cytomegalovirus (CMV) seropositive adult recipients [R+] undergoing allogeneic hematopoietic stem cell transplantation (HSCT) for the prevention of cytomegalovirus infection and cytomegalovirus disease
.

Domestic review and approval · new acceptance

This week, CDE added 26 new production acceptance numbers, totaling 19 varieties.
Among them, Hengrui Medicine's SHR8008 capsules have attracted much attention.
For more information, see the table below:

Data source: Yaozhi Data

The new antifungal drug introduced by Hengrui Medicine is declared for listing

SHR8008 is a new type of antifungal drug introduced by Hengrui Medicine from Mycovia Pharmaceuticals with over US$100 million.
The indication for this application is acute vulvovaginal candidiasis (VVC, also known as fungal vaginitis, vulvar vaginal candidiasis)
.
According to the announcement issued by Hengrui Medicine in November, the cure rate of SHR8008 in the treatment of acute VVC is significantly better than that of fluconazole
.

In addition, Hengrui Medicine is conducting another Phase 3 clinical trial called SHR8008-301 to evaluate the efficacy and safety of SHR8008 capsules in the treatment of recurrent vulvovaginal candidiasis (RVVC)
.
In the United States, the FDA has accepted the drug's New Drug Application for the treatment of RVVC and granted it priority review status with a PDUFA target date of January 27, 2022
.