AbbVie's Humira Approved in China for Fourth Indication: Pediatric Polyarticular Juvenile Idiopathic Arthritis

[2019.11.8/R&D NEWS]Expanding into Pediatrics! AbbVie’s Skyrizi Approved for Its Fourth Indication in China; Keytruda Poised for Approval of Its Fourth Indication in China—First-Line Treatment for Squamous NSCLC; Eisai’s New Alzheimer’s Drug BAN2401 Granted Clinical Trial Approval in China; Lukang Pharma’s Amoxicillin Capsules Pass the Generic Drug Consistency Evaluation...

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[Drug Development]

Takeda’s Proteasome Inhibitor Meets Primary Endpoint in Phase 3 Clinical Trial

Today, Takeda announced that its proteasome inhibitor Ninlaro (ixazomib), as a first-line maintenance therapy, significantly improved progression-free survival (PFS) in adult patients with multiple myeloma (MM) who had not undergone stem cell transplantation, thereby meeting the primary endpoint of the Phase 3 trial.

Teva Launches First Rituxan Biosimilar, Truxima: Roche’s Blockbuster Biologic Falls

Teva Pharmaceuticals and Celltrion recently announced the joint launch of Truxima (rituximab-abbs) in the U.S. market. Truxima is a biosimilar to Roche’s flagship biologic Rituxan (generic name: rituximab), with a full oncology label.

[Drug Approval]

Expanding into Pediatrics! AbbVie’s Skyrizi Approved for Its Fourth Indication in China

Today, AbbVie’s official WeChat account announced that its product Humira (adalimumab injection) has been approved by China’s National Medical Products Administration (NMPA) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA), becoming the first biologic agent approved in mainland China for this indication.

Eisai’s New Alzheimer’s Drug BAN2401 Approved for Clinical Trials in China

On November 8, the Center for Drug Evaluation (CDE) of the National Medical Products Administration updated a batch of clinical trial implicit approval lists, among which Eisai (China)'s new Alzheimer's drug BAN2401 was approved for clinical trials, intended for the improved treatment of mild Alzheimer's disease (AD) and mild cognitive impairment (MCI) caused by Alzheimer's disease (AD).

Keytruda Poised for Approval of Its Fourth Indication in China: First-Line Treatment for Squamous NSCLC

On November 6, according to the official website of the National Medical Products Administration (NMPA), the marketing application for a new indication of Keytruda (pembrolizumab; brand name: Keytruda/KeRuiDa) (Acceptance Number: JXSS1800025) has entered the "under review" status and is expected to be approved for marketing this month.

Second in China! Chengdu Yuandong Bio's "Etoricoxib Tablets" Approved

On November 7, Chengdu Yuandong Biopharmaceutical’s etoricoxib tablets, submitted under the new Class 4 application pathway, were approved for market launch and deemed to have passed the consistency evaluation. This makes Yuandong Biopharmaceutical the second company in China to achieve consistency evaluation approval for this product, following Qilu Pharmaceutical.

The First Blockbuster Drug to Pass the Consistency Evaluation

On November 7, Jiangsu Nhwa Pharmaceutical issued the “Announcement on Clozapine Tablets Passing the Consistency Evaluation,” announcing that its clozapine tablets (25 mg) had passed the consistency evaluation. The letrozole tablets (2.5 mg) approved for consistency evaluation by Hisun Pharma were originally developed by Novartis of Switzerland; the drug was first approved for marketing in the United States in 1997 and approved for import into China in 2003.

Lukang Pharma’s Amoxicillin Capsules Pass the Generic Drug Consistency Evaluation

On November 7, Lukang Pharma announced that the company had recently received the "Drug Supplementary Application Approval" (Approval Numbers: 2019B04059, 2019B04060) issued by the National Medical Products Administration regarding Amoxicillin Capsules. The drug has passed the consistency evaluation of quality and efficacy for generic drugs.