With the second week of July coming to a close, let’s review the hot events of the pharmaceutical industry this week. The news involved 6 sections: approval, R&D, policies, transactions, listing and miscellany that happened during July 6-10, including 21 pieces.

Approval

NMPA

1. GSK’s marketing application for mepolizumab injection in China was accepted by the CDE on July 6, which is the first anti-IL-5 monoclonal antibody applied for marketing in China. Approved by the FDA for marketing in Nov. 2015, mepolizumab has been approved for indications including eosinophilic asthma and churg-strauss vasculitis.

2. The marketing review of Henlius’ “Trastuzumab Biosimilar” was dequeued from CDE review on July 7, which is expected to be approved for marketing soon after two rounds of data supplementation, production site inspection, and clinical trial site checking, to become the first Chinese-produced trastuzumab biosimilar.

3. According to the NMPA website on July 8, the marketing application for the 450mg specification of Green Valley Pharmaceutical’s Sodium Oligomannurarate Capsules was not approved. Green Valley Pharmaceutical filed the marketing applications for the 150mg and 450mg specifications of the variety in Nov. 2018; wherein, the 150mg specification was conditionally approved by the NMPA for marketing in Nov. 2019 to treat mild to moderate Alzheimer’s disease.

4. According to the CDE website on July 9, the marketing application for Class 1 new drug “Azvudine Tablets” jointly filed by Beijing Union Pharmaceutical Factory and Henan Genuine Biotech was accepted. Azvudine (FNC) is the world’s first inhibitor that targets both HIV reverse transcriptase and accessory protein Vif and China’s first anti-HIV oral drug with independent intellectual property.

FDA

5. Concert Pharmaceuticals announced on July 8 that the FDA granted a Breakthrough Therapy Designation to its CTP-543, an oral JAK inhibitor, for the treatment of moderate to severe alopecia areata in adults. The FDA has not approved any drug for alopecia areata so far.

6. On July 8, MSD/Eisai announced that they received a Complete Response Letter (CRL) for Keytruda plus lenvatinib combination as a first-line treatment for unresectable hepatocellular carcinoma (HCC), according to which, the FDA rejected the accelerated marketing application thereof for the time being.

CHMP

7. Novartis announced on July 7 that its triple inhalation therapy: Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide, and mometasone furoate) was officially approved by the EU for marketing. As the world’s first triple compound formulation for the treatment of asthma, Enerzair Breezhaler is used as a maintenance treatment for asthma in adult patients not adequately controlled with a maintenance combination of a LABA/IC who experienced one or more asthma exacerbations in the previous year.

Related News:

Pharmaceutical News of the Week (July. 6th-July. 10th) | PharmaSources.com - Updates on R&D

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.

-----------------------------------------------------------------------
Editor's Note:

To become a freelance writer of PharmaSources.com,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@imsinoexpo.com.