Two Drugs Recommended for Priority Review and Two New Drug Applications Submitted in China: AstraZeneca/Daiichi Sankyo’s Enhertu Among Key Highlights

According to the CDE official website, two drugs are proposed for priority review, and two drugs have been submitted for marketing! They are Enhertu from AstraZeneca/Daiichi Sankyo, injectable Cytarabine from China National Pharmaceutical Group Unity, Dolutegravir from Qilu Pharmaceutical, and Andaxini from Jingxin Pharmaceutical.

Two Drugs Proposed for Priority Review

AstraZeneca/Daiichi Sankyo: Enhertu Proposed for Priority Review

According to the announcement on the CDE official website, the marketing application for trastuzumab deruxtecan injection is proposed to be included in the priority review, targeting unresectable or metastatic HER2-positive adult breast cancer patients. Public information shows that Enhertu (trastuzumab deruxtecan) is an antibody-drug conjugate (ADC) targeting HER2 jointly developed by AstraZeneca and Daiichi Sankyo, which has been approved for marketing overseas. Not long ago, the drug was just included in the breakthrough therapy designation in China.

Enhertu is an ADC product designed using Daiichi Sankyo's proprietary DXd ADC technology platform. It consists of a humanized monoclonal antibody targeting HER2, linked to a topoisomerase I inhibitor payload through a cleavable tetrapeptide linker.

In the United States, Enhertu has been approved by the FDA for third-line treatment of patients with HER2-positive unresectable or metastatic HER2-positive breast cancer who have been previously treated, as well as for the treatment of patients with HER2-positive locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma who have received trastuzumab-based therapy.

According to the priority review announcement, the indication for which Enhertu has applied for marketing authorization this time is: monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies.

China National Pharmaceutical Group: Injectable Cytarabine Proposed for Priority Review

According to the CDE official website, China National Pharmaceutical Group's Cytarabine Injection is proposed for priority review, mainly used for induction remission and maintenance treatment of acute non-lymphocytic leukemia in adults and children.

Two Drugs Submitted for Marketing Approval

Qilu Pharmaceutical: Dolutegravir Submitted for Market Approval

According to the CDE official website, Qilu Pharmaceutical's Dolutegravir Sodium Tablets submission for marketing approval has been accepted. Dolutegravir is an anti-AIDS drug, and this is the first generic Dolutegravir Sodium Tablets submission for marketing approval in China.

The original dolutegravir (dolutegravir, trade name: Tivicay) is an HIV integrase inhibitor developed by ViiV Healthcare, a subsidiary of GlaxoSmithKline (GSK). It can block HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells.

Jingxin Pharmaceutical: Andaxini Submission for Market Launch

According to the CDE official website, the marketing application for Zhejiang Jingxin Pharmaceutical's Class 1 new drug, Andaxini Capsules, has been accepted by the National Medical Products Administration for the treatment of insomnia disorder (Acceptance No.: CXHS2200018). This is Jingxin Pharmaceutical's first small molecule innovative drug marketing application.

Andaxini (R&D code: EVT201) is a Class 1 small-molecule new drug for the treatment of insomnia disorder. It is a partial positive allosteric modulator of the GABAA (γ-aminobutyric acid A) receptor, acting selectively on the α1 subtype of the GABAA receptor. It exhibits high affinity and moderate agonistic activity, which can induce rapid sleep onset and maintain sleep. Compared with traditional full GABA receptor agonists, it has significant advantages in terms of side effects such as motor disorders, residual effects, tolerance, ethanol interactions, physical dependence, and memory impairment.

Editor: Qijin

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