Four Drugs Receive Clinical Approval and Two New Indications Granted in China: Roche, AstraZeneca, Qilu Among Key Players

According to the latest information from the NMPA website, CDE website, and company announcements, four drugs have been approved for clinical trials, and two new indications have been approved! These include an anti-CD73 antibody, IL-5 antagonist, ALK inhibitor, etc., from companies such as Roche, AstraZeneca, and Qilu.

Four Drugs Approved for Clinical Trials

AstraZeneca: oleclumab, monalizumab

The CDE official website shows that two Class 1 new drugs from AstraZeneca have received implied permission for clinical trials: the anti-CD73 antibody oleclumab and the anti-NKG2A antibody monalizumab. The proposed indications for development are both: to be used in combination with the anti-PD-L1 antibody durvalumab (Imfinzi) for the treatment of locally advanced, unresectable non-small cell lung cancer (NSCLC). These patients previously did not progress after radical platinum-based concurrent chemoradiotherapy.

CD73 and NKG2A are both emerging targets in cancer immunotherapy.

GSK: Depemokimab Injection

CDE Official Website Announcement: Depemokimab Injection Submitted by GSK Approved for Clinical Trials in China, with the Proposed Indication of Eosinophilic Granulomatosis with Polyangiitis.

According to publicly available data from GSK, depemokimab is a long-acting IL-5 antagonist that has the potential to control patients' symptoms with an injection every six months. The drug is currently undergoing Phase 3 clinical trials overseas for various indications.

Qilu Pharmaceutical: Risperidone Oral Soluble Film

CDE official website shows that Qilu Pharmaceutical's Risperidone Oral Soluble Film has obtained clinical trial tacit permission.

This medication is indicated for schizophrenia in adults and adolescents aged 13-17. For patients who respond effectively to acute treatment, the medication can continue to demonstrate clinical efficacy during the maintenance phase; manic episodes associated with bipolar disorder in adults and children/adolescents aged 10-17; irritability associated with autism in children and adolescents aged 5-17; and persistent aggression or other disruptive behaviors associated with intellectual disability, mental retardation, or conduct disorders in children and adolescents aged 5-17.

Yinming Bio: GGW0014

Yinming Biotechnology announced that GGW0014, an original small-molecule drug under development by its subsidiary company Gegewu, completed the clinical trial filing for a new Class I veterinary drug on March 17, 2022. The drug is intended to treat pruritus caused by canine atopic dermatitis and will soon commence clinical trials in China.

GGW0014 is the second novel Class 1.1 pet drug developed by Greghouse to enter clinical trials this year, following ZYF0033, the first-in-class small molecule drug for treating feline infectious peritonitis, which entered clinical trials in January.

Two New Indications Approved

Betta Pharmaceuticals: New Indication for Ensartinib Approved

The NMPA official website shows that Betta Pharmaceuticals' ALK inhibitor Ensartinib Capsules has been approved for a new indication, as first-line treatment for ALK-positive NSCLC.

Roche: Atezolizumab Approved for New Indication

Roche announced that the NMPA has officially approved the company's innovative immuno-oncology drug, atezolizumab, as a monotherapy for the adjuvant treatment of patients with stage II-IIIA non-small cell lung cancer (NSCLC) who have undergone surgery and platinum-based chemotherapy, and whose tumor cells (TC) show PD-L1 staining in ≥1% of cells. The press release noted that, as of the day of approval, this is the first approved indication for adjuvant immunotherapy for NSCLC post-surgery in China.

Editor: Jiao Ba

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