Hengrui and Huahai Secure FDA Approvals for Generic Drugs; TRACON Halts Development of Envafolimab
TRACON
Developer of Cancer Targeted Therapy Drugs
Hengrui Pharma
Innovative and High-Quality Pharmaceutical Developer
Huahai Pharmaceutical
Medical and Health Product Provider
Alphamab Oncology
Developer of Antibody and Protein Macromolecule Drugs
Novartis China
Innovative Drug Developer
Geneseeq
Genetic Testing Product Developer
Gloria Pharmaceuticals
Pharmaceutical R&D Developer
Chinese-produced generic drugs are increasingly entering the international market.
On July 2, Hengrui Pharma announced that the ANDA (Abbreviated New Drug Application) for Bupivacaine Liposome Injectable submitted to the U.S. FDA has been approved, making it the first Chinese pharmaceutical manufacturer to gain approval for this generic drug in the United States.
On the same day, Huahai Pharmaceutical also announced that the company's Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets submitted to the U.S. FDA has received tentative approval. Rivaroxaban Tablets are mainly used for the treatment and prevention of thrombosis.
Alphamab Oncology's PD-L1 Project Encounters Setback.
On July 1, TRACON announced that it would terminate the further development of Envafolimab in collaboration with Alphamab Oncology and stated that it may adopt strategic actions such as business mergers, asset sales, licensing, acquisitions, or reverse mergers in the future.
Novartis Accelerates Radioactive Drug Layout in China.
On July 2, Novartis China announced the official launch of construction for its radiopharmaceutical production project in Haiyan, Zhejiang. This is the first radioligand therapy production base established by Novartis in China, and also its second innovative drug production base in the country. The total investment for the project is expected to reach 600 million RMB, with plans to complete construction and begin operations by the end of 2026.
In the past day, what hot topics in the pharmaceutical markets at home and abroad are worth paying attention to? Let Amino take you to explore.
/ 01 /
Market Express
1) Novartis China's Radiopharmaceutical Production Project Officially Launches Construction
On July 2, Novartis China's radiopharmaceutical production project officially commenced construction in Haiyan, Zhejiang. This is Novartis' first radioligand therapy production base in China and its second innovative drug production base in the country, with a total investment of 600 million yuan. The facility is expected to be completed and put into operation by the end of 2026.
2) Minimally Invasive Cardiovascular Acquires European Device Company
On July 1, MicroPort CardioFlow announced that it plans to use its own funds of 65 million US dollars to acquire 72.37% of the equity in Optimum Medical Device Inc., a joint venture of MicroPort CardioFlow, held by Earl Intellect Limited and Turbo Heart Limited. After the completion of this transaction, Optimum Medical will become a wholly-owned subsidiary of MicroPort CardioFlow.
3) Shihe Gene and Jiangsu Weikai Reach NTRK Companion Diagnostic Strategic Cooperation
On July 2, Nanjing Shihe Gene Biotechnology Co., Ltd. and Jiangsu Weikai Biotech signed a strategic cooperation agreement. The two parties will comprehensively cooperate on the development and future commercialization of the companion diagnostic kit for the NTRK inhibitor VC004.
/ 02 /
Capital Information
1) Gloria Pharmaceuticals Expects 254%-360% Year-on-Year Growth in Net Profit for the First Half of the Year
On July 2, Gloria Pharmaceuticals announced that it expects a net profit of 100 million to 130 million yuan for the first half of the year, representing a year-on-year increase of 253.99%-360.19%.
2) Minimally Invasive Brain Science (Suzhou) Co., Ltd. expects an increase of approximately 34% to 37% in revenue year-over-year for the first half of the year.
On July 2, Minimally Invasive Brain Science (Suzhou) Co., Ltd. announced that its estimated revenue for the first half of the year will reach 400 million to 410 million yuan, representing a year-on-year increase of approximately 34% to 37%.
/ 03 /
Pharmaceutical News
1) Hengrui Pharma's Bupivacaine Liposome Injection ANDA Approved by U.S. FDA
On July 2, Hengrui Pharma announced that the company's ANDA for Bupivacaine Liposome Injectable Suspension submitted to the U.S. FDA has been approved, making it the first manufacturer to gain approval for this generic drug in the United States.
2) Huahai Pharmaceutical's Rivaroxaban Tablets Receive Temporary Approval from U.S. FDA
On July 2, Huahai Pharmaceutical announced that the Abbreviated New Drug Application (ANDA) for Rivaroxaban Tablets submitted to the U.S. FDA has received tentative approval. Rivaroxaban Tablets are mainly used for the treatment and prevention of thrombosis.
3) Johnson & Johnson's JNJ-88998377 Oral Tablets Approved for Clinical Trials
On July 2, according to the CDE website, Johnson & Johnson's JNJ-88998377 oral tablets have been approved for clinical trials to treat B-cell non-Hodgkin lymphoma, mantle cell lymphoma, mucosa-associated lymphoid tissue lymphoma, follicular lymphoma, and Waldenström macroglobulinemia.
4) NeuShen Pharma's NS-136 Tablets Approved for Clinical Trials
On July 2, according to the CDE official website, NeuShen Pharma's NS-136 tablets have been approved for clinical trials, aiming to conduct research on the treatment of schizophrenia.
5) Gloria Pharmaceuticals' Recombinant Botulinum Toxin Type A for Injection Approved for Clinical Trials
On July 2, according to the CDE website, Yuyan Pharmaceutical's recombinant botulinum toxin type A for injection has been approved for clinical trials, aiming to conduct research on treating upper limb spasticity in adults.
6) Zai Lab's Efgartigimod Injection Approved for Clinical Use
On July 2, according to the CDE website, Zai Lab's Efgartigimod injection has been approved for clinical trials, aiming to conduct research on the treatment of thyroid eye disease.
7) Innovent Biologics Announces Latest Clinical Data of CLDN18.2 ADC
On July 2, Innovent Biologics announced the latest Phase 1 study data on CLDN18.2 ADC for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma at the 2024 ESMO GI oral presentation. In high-expression patients, the objective response rate (ORR) and disease control rate (DCR) were 36.7% and 93.3%, respectively. In the 8mg/kg dose group, the ORR was 47.1% and the DCR was 88.2%.
8) Huahao Zhongtian's Utidelone Approved for Phase 2 Clinical Trial by FDA
On July 2, Huahao Zhongtian announced that the U.S. Phase II clinical trial of Utidelone Injection for the treatment of HER2-negative breast cancer brain metastases has been approved by the U.S. FDA. This study aims to evaluate the intracranial and systemic efficacy and safety of Utidelone Injection combined with Capecitabine in patients with HER2-negative BCBM.
/ 04 /
Instrument Tracking
1) Peijia Medical Balloon Dilation Catheter Approved for Marketing
On July 2, according to the NMPA website, Peijia Medical's balloon dilation catheter was approved for marketing.
2) LifeTech Ceramic Membrane Atrial Septal Defect Occluder Approved for Marketing
On July 2, according to the NMPA website, Lifetech Scientific's ceramic membrane atrial septal defect occluder was approved for marketing.
/ 05 /
Overseas Pharmaceutical News
1) TRACON terminates the development of Envafolimab
On July 1, TRACON announced a research decision to terminate the further development of Alphamab Oncology's Envafolimab. In the future, strategic actions such as business mergers, asset sales, licensing, acquisitions, or reverse mergers are not ruled out.
Text by Huang Kai
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