NMPA Approves Multiple Innovative Drugs on Same Day, Including Taletrectinib Capsules from Baolai Bio and Allergen Skin Prick Solutions from Woful Biotech

　　【Pharmaceutical Network Product InformationAccording to the news on the website of the National Medical Products Administration on December 20, several new innovative drugs have been approved for marketing, from companies including WOLWOPHARMA and others.
 

Among them, the National Medical Products Administration (NMPA) has granted conditional approval for the marketing of Tarextumab Adipate Capsules (brand name: Dabole), a Class 1 innovative drug submitted by Baoyuan Biomedical (Hangzhou) Co., Ltd., through the priority review and approval process. This medication is indicated for adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after ROS1-TKI treatment.
 

Relevant sources indicate that Diacid Tarextumab Capsules, as a targeted lung cancer treatment drug, offer a new therapeutic option for adult patients with non-small cell lung cancer. There are tens of thousands of eligible patients globally for Diacid Tarextumab Capsules, with a significant proportion being Chinese patients. The drug demonstrates excellent clinical efficacy and favorable safety.
 

From research and development to market launch, the capsule Telisotuzumab Hexanedioic Acid has undergone clinical trials and other stages over six years and with an investment of several hundred million yuan. With the multifaceted service support from Hangzhou Medicinal Port, AnBio Pharma completed the initiation of the Phase II clinical trial from scratch in just over a year.
 

It is reported that, in order to support the funding needs for the early development of the biopharmaceutical industry, Qiantang District has established a 5 billion yuan industry mother fund and direct investment fund, which will work in conjunction with Zhejiang Province’s “4+1” biopharmaceutical industry fund to "protect and guide" the development of enterprises. In addition, Qiantang District fully utilizes the high-quality development policies for the biopharmaceutical industry at the provincial and municipal levels, and based on the actual situation of industrial development, has introduced the "Leading Flight Plan". Each year, no less than 20% of fiscal expenditure is prioritized to provide targeted support to companies of different types, stages, and sizes. With the superimposed effects of policies at the provincial, city, and district levels, an innovative drug can achieve milestone breakthroughs at every stage from research and development to clinical trials and approval for market entry, with cumulative rewards reaching up to 70 million yuan.
 

In addition, the National Medical Products Administration has approved the listing of three allergen skin prick solutions submitted by WOLWOPHARMA, namely German cockroach allergen skin prick solution, cat hair and dander allergen skin prick solution, and Platanus pollen allergen skin prick solution. These products are used for skin prick testing to assist in diagnosing Type I hypersensitivity reactions associated with sensitization to German cockroaches, cat hair and dander, and Platanus pollen.
 

In addition to the above-mentioned domestically produced innovative products, on December 20, the website of the National Medical Products Administration also showed that the donanemab injection (trade name: Kisenuda) applied by Eli Lilly and Company was approved for marketing, used for treating mild cognitive impairment caused by Alzheimer's disease and mild dementia of Alzheimer's disease.
 

The formation of β-amyloid (Aβ) plaques in the brain is one of the typical pathophysiological characteristics of Alzheimer's disease. Donanemab is a humanized immunoglobulin IgG1 monoclonal antibody targeting Aβ. In clinical studies, donanemab has been shown to reduce Aβ plaques and slow the progression of Alzheimer's disease-related symptoms. The approval of this drug provides a new treatment option for patients with Alzheimer's disease.
 

Alzheimer's disease is a fatal condition that leads to the gradual decline of memory and other cognitive functions. Data shows that 32 million people worldwide are living with Alzheimer’s dementia and have confirmed amyloid pathology, including nearly 9.83 million current Alzheimer’s patients in China.
 

The pivotal Phase 3 study of this new drug showed that, compared with the placebo group, Jienengda slowed cognitive and functional decline by up to 35%. Additionally, for subjects in the earlier stages of the disease, it reduced the risk of disease progression by up to approximately 39% over 18 months.
 

It is reported that this new drug has achieved synchronized submission in China, Europe, the United States, and Japan. Following its approval in the United States in July 2024, it was registered and approved by the National Medical Products Administration of China as a Class 1 innovative drug in December.
 

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