Hengrui's class 1 new drug is listed on the market!

Domestic review and approval · new trends

In this issue, CDE has 54 acceptance numbers (36 varieties) reported to update the production management stat.

Data source: Yaozhi Data

Haisco Cyclopofol Injection Approved for New Indications

According to Yaozhi data, the fourth indication of Haisco Cyclopofol Injection has been approved by NMPA for marketi.

Cyclopofol (HSK3486) is a brand-new intravenous anesthesia drug with independent intellectual property rights developed by His.

At present, cyclopofol has been declared for 5 indications, including "induction of general anesthesia", "sedation and anesthesia in non-tracheal intubation surgery/operation", "induction and maintenance of general anesthesia" and "sedation during intensive care" Four indications have been approved for marketing by the State Drug Administration; "Sedation and Anesthesia for Outpatient Gynecology Surgery" is still under approval for marketing applicatio.

According to the "National Medical Insurance List (2021 Edition)", cyclopofol was included in the medical insurance through national negotiati.

The new bone marrow protection drug introduced by Simcere Pharma has been approved in China!

Recently, the world's first innovative drug Triracciril (trade name: Cocyla) introduced by Simcere has been approved for marketing in China with conditio.

Tralaciride is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor jointly developed by Simcere and G1 Therapeuti.

Data source: Yaozhi Data

Among the five CDK4/6 inhibitors, most of them are aimed at advanced breast canc.

Domestic review and approval · new acceptance

       In this issue, CDE has newly reported 53 production acceptance numbers, with a total of 37 varieties, including SHR8554 injection of Hengrui Medicine, liraglutide injection of Huadong Medicine, etanercept for injection of Qilu Pharmaceutical, and Zai Lab The Igamod alpha injection has attracted much attention, and more developments are shown in the following table:

       Data source: Yaozhi Data

       Hengrui Medicine's Class 1 new drug SHR8554 is declared for listing

       Recently, Hengrui Medicine's self-developed Category 1 new drug SHR8554 injection for the treatment of moderate to severe pain after abdominal surgery has been accepted by C.

       Opioids are the most commonly used drugs for the treatment of moderate to severe acute and chronic pa.

       SHR8554 injection is a class 1 new drug independently developed by Hengrui Medici.

       The phase III clinical trial of SHR8554 injection (SHR8554-301) showed that SHR8554 injection can effectively treat moderate to severe pain after abdominal surgery, and significantly improve the subjects' satisfaction with analgesic treatme.

       In addition to post-abdominal surgery analgesia, Hengrui Medicine is also developing SHR8554 injection for post-orthopaedic surgery analgesia, combined with κ opioid receptor (KOR) agonist SHR0410 for post-operative acute moderate to severe pain, e.

       Huadong Medicine Liraglutide "Weight Loss" Indication Marketing Application Accepted

       Recently, the marketing authorization application for liraglutide injection for obesity or overweight indications submitted by Huadong Medicine has been accepted by C.

       Liraglutide is a human glucagon-like peptide-1 (GLP-1) receptor agonist, and Liraglutide Injection in East China is a biosimilar of Novo Nordisk's product Novol.

       Around the GLP-1 target, Huadong Medicine has also deployed projects such as semaglutide injection, DR10624, HDM1003 (SCO-094), and TTP27

       Qilu Pharmaceutical's etanercept resubmitted for listing

       According to Yaozhi data, Qilu Pharmaceutical's biosimilar "etanercept" has once again submitted a marketing applicati.

       Etanercept is the first TNF antagonist approved for rheumatoid arthritis (R.

Approved for marketing (trade name: Enbrel, Enbrel.

At present, three etanercept biosimilars have been approved for marketing in Chi.

The first one is from Sunshine Guojian, which was approved for the first time in January 2005, earlier than the original drug Enl.

The other two are from Saijin Pharmaceutical and Hisun Pharmaceutic.

       Zai Lab announces another new drug for rare diseases

       On July 13, the first-of-its-kind FcRn antagonist efgartigimod introduced by Zai Lab was officially accepted by CDE for the treatment of systemic myasthenia grav.

       According to a Zai Lab press release, Efgartigimod is the first and currently only approved FcRn antagonist, and will be approved for marketing in the United States in December 2021 for the treatment of acetylcholine receptor (AChR) antibody-positive adults with generalized myasthenia gravis; 2022 In January 2018, it was approved for marketing in Japan for the treatment of adult patients with generalized myasthenia gravis who have not adequately responded to steroid or non-steroid immunosuppressive therapies (IST.

The approval in the US and Japan is based on the pivotal Phase 3 ADAPT study of efgartigimod, which showed that 68% of patients treated with efgartigimod achieved remission, compared with 30% in the placebo gro.

       In January 2021, Zai Lab entered into an exclusive licensing partnership with argenx to develop and commercialize efgartigimod in Greater China, with a total transaction value of US$175 milli.

Previously, the drug has successfully landed in Hainan Boao Lecheng International Medical Tourism Pilot Zo.