CPhI Pharma Online (5.31-6.4)

This week, the WHO announced that the new crown vaccine developed by Kexing Zhongwei will be included in the emergency use list, becoming the second domestic new crown vaccine listed by the WHO in the EUL
.

This week’s review includes review, R&D, centralized procurement, trading and other 5 sectors.

Review

NMPA

Listed

1.
On May 31, the official website of NMPA showed that the new drug listing application of Zejing Pharmaceutical's Class 1 new drug Donafenib Tosylate is in the "under review" stage, and will be approved for marketing in the near future for the treatment of late stage (inoperable or inoperable).
Metastatic) hepatocellular carcinoma
.

Donafenib tosylate tablets is an oral multi-target, multi-kinase inhibitor class of small molecule anti-tumor drugs

2.
On May 31, the NMPA official website showed that the new indication application (sNDA) for the first-line treatment of squamous non-small cell lung cancer (NSCLC) for PD-1 Sintilimab injection jointly developed by Innovent and Eli Lilly It is in the "under review" stage and will soon be approved for marketing .
This will be the third indication for the product to be approved
.

3.
On May 31, the official website of NMPA showed that Levoornidazole Disodium Phosphate for Injection, a new class 1 drug of Yangzijiang Pharmaceutical, has been approved for marketing
.

Levoornidazole Disodium Phosphate is a nitroimidazole antibiotic.

       4.
On May 31, the official website of NMPA showed that Hengrui's application for the listing of class 3 generic azilsartan tablets was "under approval" and it is expected to be approved for listing soon
.

Azilsartan is a new generation of selective AT1 subtype angiotensin II receptor antagonist (ARBs) antihypertensive drug developed by Takeda Pharmaceutical

       5.
On May 31, the official website of NMPA showed that Hausen Erlotinib Hydrochloride Tablets was approved, becoming the second domestic generic drug of this variety
.

Erlotinib is the first-generation EGFR inhibitor and was approved by the FDA as early as 2004 for the treatment of locally advanced or metastatic NSCLC after at least one chemotherapy failure

       6.
On June 2, NMPA passed the priority review and approval procedure to approve the listing of Contizolamide Tablets ( trade name: Youxitai), a class 1 innovative drug of Shanghai Mengke Pharmaceutical
.

The drug is a new generation of oxazolidinone antibacterial drugs, used to treat Staphylococcus aureus (methicillin sensitive and resistant strains), Streptococcus pyogenes or Streptococcus agalactiae that are sensitive to contizolamide Complex skin and soft tissue infections

       7.
On June 2nd, NMPA showed that Hainan Simcere Pharmaceutical's application for the listing of 4 types of generic drug Idoxaban tosylate tablets was accepted for the treatment of stroke and prevention of systemic embolism in patients with atrial fibrillation, which was the first domestic product of this product.
Family report property
.

Idoxaban tosylate was developed by Daiichi Sankyo, Japan, and was the first to be marketed in Japan in April 2011 for venous thromboembolism (VTE).

       8.
On June 3, NMPA issued an approval document, and Roche's second-generation CD20 monoclonal antibody Obinutuzumab (Otuzumab, trade name Gazyva) was approved for marketing
.

As an upgraded product of Roche rituximab, otuzumab has seen its sales increase year after year since its launch.

       9.
On June 3, NMPA issued an approval document, and Betta Pharmaceuticals' new indication for postoperative adjuvant treatment of icotinib was approved for marketing .
This is the third indication approved for the drug
.
Icotinib is China's first small molecule targeted anticancer drug with independent intellectual property rights independently developed by Betta, and it has been on the market for more than 9 years
.

       clinical

       10, May 31, St.
Pharmaceutical PRMT5 small molecule inhibitors SH3765 chip to obtain clinical trial license , intended for the treatment of advanced malignancies, including but not limited to solid tumors, non-Hodgkin's lymphoma
.
Prior to this, SH3765 tablets have been approved by the US FDA for clinical trials on February 11, 2021
.
This product is the first PRMT5 inhibitor approved for clinical use in China
.

       FDA

       11.
On June 1, Wanchun Medicine announced that the NDA application for the use of pranabulin concentrated solution for injection for severe neutropenia (CIN) caused by chemotherapy has been formally accepted by the FDA and has been granted priority review.
The scheduled approval period for PDUFA is November 30, 2021
.
Pranabrin is the First-In-Class GEF-H1 activator independently developed by Wanchun Pharmaceutical
.

       12.
On June 2, Boehringer Ingelheim and Zealand Pharma jointly announced that the FDA has granted GLP-1/glucagon receptor (GCCR) dual agonist BI456906 fast track designation for adult non-alcoholic steatohepatitis (NASH)
.

       BI456906 is derived from the natural intestinal hormone oxyntomodulin, which is expected to be a new once-a-week dosing treatment that is superior to the existing therapies
.

R&D

       13.
On June 1, Immutep announced that it had reached a cooperation agreement with Merck, Germany.
The two parties will conduct a phase I/IIa clinical trial called INSIGHT-005 in solid tumor patients to evaluate Immutep's candidate product Eftilagimod The feasibility, safety and effectiveness of combined use with Merck Bintrafusp alfa
.
Bintrafusp alfa is a first-in-class bifunctional fusion protein targeting PD-L1/TGF-β jointly developed by Merck and GSK in Germany
.

Collect

       14.
On June 2, Shanghai Sunshine Pharmaceutical Purchasing Network released the fifth batch of national drug centralized procurement documents
.
The purchased varieties were reduced from 60 varieties at the time of reporting to 58 varieties.
Mifepristone and carbetocin were eventually not included in the collective procurement list due to various reasons
.
The three varieties of dabigatran etexilate capsules, iohexol injection, and rivaroxaban tablets were separated into different serial numbers due to different specifications, and the final list of collectively collected varieties was 62 serial numbers
.

transaction

       15.
On June 1, Shenzhou Cell and Magnesium Health held a strategic cooperation signing ceremony.
Both parties will conduct comprehensive and in-depth cooperation based on their respective advantages in the fields of medical health, innovative payment and insurance services
.
SCT800 independently developed by Shenzhou Cell, as the first domestic recombinant human coagulation factor Ⅷ, will be officially launched soon
.

       16.
On June 1, Cinda Biotech and Baoyuan Biotech jointly announced the agreement between the two parties.
As an exclusive partner, Cinda Biopharmaceuticals and Baoyuan Biopharmaceuticals have joint development in Greater China (including Mainland China, Hong Kong, Macau and Taiwan).
And the right to commercialize Baoyuan Pharmaceutical’s main drug candidate Taletrectinib.
Taletrectinib is a next-generation tyrosine kinase inhibitor targeting ROS1 and NTRK
.

       17.
On June 1, Novo Nordisk and Heart Seed announced that the two parties have reached an exclusive global cooperation and licensing agreement for HS-001 stem cell therapy, with a total transaction amount of US$598 million
.
HS-001 is an experimental cell therapy developed by Heart Seed Company.
Purified cardiomyocytes are extracted from induced pluripotent stem cells (iPSC) for the treatment of heart failure
.

       18.
On June 1, Huadong Medicine announced that it had reached a cooperation with Japan's SCOHIA company , and obtained the GLP-1/GIPR dual target in clinical phase I with a down payment of 4 million US dollars + development, registration and sales milestone payment of up to 24 million US dollars The exclusive development, production and commercialization rights of the agonist hypoglycemic drug SCO-094 in 25 Asia-Pacific countries and regions (excluding Japan) including China, South Korea, Australia and so on
.

       19.
On June 1, Amgen and Concord Fermented Kirin announced that the two parties have reached a cooperation agreement to jointly develop and commercialize KHK4083, which is a potential first-in-class anti-OX40 human source under development by Concord Fermented Kirin.
Monoclonal antibodies are used to treat atopic dermatitis and have the potential to treat other autoimmune diseases
.

other

       20.
On June 2, WHO held a press conference and announced that the new crown inactivated vaccine of Kexing Zhongwei will be included in the emergency use list
.
This is the second domestic new crown vaccine listed by the WHO on the emergency use list after the new crown vaccine of the Beijing Institute of Biological Products of Sinopharm Group
.