Novartis Migraine Preventive Drug Approved in China; Tsinghua-Affiliated Team Launches Billion-Parameter 'Pharma-ChatGPT'

Reporter Chen Hao from Every Day, Editor Yang Xia from Every Day

1. Novartis' migraine prevention drug approved for marketing in China

Novartis announced that the marketing application for erenumab injection (erenumab) for the preventive treatment of migraine in adults has been officially approved in China. Erenumab is a CGRP receptor antagonist administered once a month via self-injection, allowing patients to complete the dosing process within 15 seconds with simple operation. Erenumab is a humanized monoclonal antibody jointly developed by Novartis and Amgen, specifically designed as a preventive migraine treatment to block the CGRP receptor, which plays a key role in migraine.

Comment:Migraine is a common chronic neurovascular disease, characterized by recurrent, unilateral or bilateral pulsating severe headaches that often occur on one side of the head, accompanied by nausea, vomiting, and sensitivity to light, sound, and odors. The drug's market launch will bring an innovative treatment option to migraine patients in China.

2. The First "Cat Triple" Vaccine Produced in China Receives Production Approval

Recently, the trivalent inactivated vaccine for feline rhinotracheitis, feline calicivirus disease, and feline panleukopenia, developed by the Shanghai Veterinary Research Institute of the Chinese Academy of Agricultural Sciences, has passed the emergency evaluation by the Ministry of Agriculture and Rural Affairs and received production approval. Feline rhinotracheitis, feline calicivirus disease, and feline panleukopenia are the three most common infectious diseases in cats. The trivalent inactivated vaccine that prevents these three major infectious diseases is also known as the "feline trivalent" vaccine.

Comment:China's pet vaccine industry started relatively late, and the domestic market for trivalent cat vaccines has long relied on foreign imports. The approval of the first domestically produced "trivalent cat vaccine" marks a significant breakthrough for Chinese-made feline vaccines, ending the long-standing monopoly of imported vaccines in China.

3. Cases Involving Commercial Bribery Affect Credit Ratings; Two Pharmaceutical Companies Issue Apology Statements

Yunnan Baiyao Group Co., Ltd. Traditional Chinese Medicine Decoction Pieces Branch and GUANGDONG YIFANG PHARMACEUTICAL CO., LTD. issued "Apology Statements." In its "Apology Statement," the Baiyao Decoction Pieces Company stated that the Yunnan Government Procurement and Outbidding Center released the "Notice on the Proposed Rating of Dishonest Conduct by Pharmaceutical Enterprises." The notice was based on a court ruling involving a certain hospital, which mentioned that the former regional manager of the company's Traditional Chinese Medicine Decoction Pieces Branch was suspected of individual bribery. The "Apology Statement" from Yifang Pharmaceutical also stemmed from the aforementioned notice, but the company did not specify the exact dishonest conduct in its statement.

Comment:Pharmaceutical enterprises in the local bidding and procurement market are rated for dishonesty at four levels: general, moderate, severe, and particularly severe. Among these, pharmaceutical enterprises found to have severe dishonesty will be restricted or suspended from listing related drugs or medical consumables, as well as restricted or suspended from procuring such drugs or medical consumables.

4. Tsinghua Team Announces Development of Billion-Parameter "Pharma ChatGPT"

On September 21, the Tsinghua-based startup team Shuimu Molecular released a new generation of conversational drug discovery assistant ChatDD (Drug Design), covering all stages of drug project initiation, preclinical research, and clinical trials. As an AI assistant to pharmaceutical experts, it enhances the efficiency of drug discovery. Additionally, the team launched ChatDD-FM 100B, the world's first large-scale multimodal biomedical dialogue model with 100 billion parameters.

Comment:With the popularity of ChatGPT, China's artificial intelligence large model products have entered the era of "thousands of models competition." In the medical field, large model products have emerged in all stages, from medical research, drug development to intelligent diagnosis and treatment, as well as medical equipment operation and maintenance, and hospital management. AI-driven drug development is bringing new changes to the industry.

5. Dizal's Golixitinib Included in Priority Review and Approval Process

Dizal Pharmaceutical announced that its product, Goliditini, has recently been included in the priority review and approval process by the Center for Drug Evaluation of the National Medical Products Administration. Goliditini is the world's first and currently the only highly selective JAK1 inhibitor in the lymphoma field at the NDA submission stage. In 2022, Goliditini received the "Fast Track Designation" from the U.S. Food and Drug Administration and is currently the first and only innovative Chinese drug targeting peripheral T-cell lymphoma (PTCL) to have received this designation.

Comment:Since its establishment six years ago, Dizal Pharmaceutical has not yet achieved profitability. In August this year, the company's first self-developed novel lung cancer targeted drug, Sunvozertinib (generic name: Sunvozertinib Tablets), was officially approved for marketing by the China National Medical Products Administration. With the addition of Golitini, which has been included in the priority review and approval process, Dizal Pharmaceutical's commercialization progress is expected to accelerate.

Cover image source: Visual China - VCG21gic6332800