Hengrui Medicine's Albumin-Bound Paclitaxel Receives FDA Approval as First Generic in the U.S.; Assisted Reproductive Technology Coverage Expands in Multiple Chinese Provinces
Hengrui Pharma
Innovative and High-Quality Pharmaceutical Developer
MindRank
AI Drug Developer
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Author | Huang Kai
Assisted Reproduction Receives New Benefits.
On October 10, according to the official WeChat account of the National Healthcare Security Administration, Hunan, Shanxi, and Sichuan have included assisted reproductive technologies within the scope of medical insurance reimbursement. This means that the number of provinces providing reimbursement for assisted reproductive services has further expanded.
Hengrui Pharma's Generic Drugs Continue to Expand Overseas.
On October 10, Hengrui Pharma announced that its ANDA (Abbreviated New Drug Application, or the U.S. generic drug application) for Paclitaxel Injection (Albumin-Bound) had been approved by the FDA. It is the first company to receive U.S. generic approval for this product.
New Progress in the Development of Chinese-produced Oral GLP-1.
On October 10, MindRank announced that the first dosing group in the Phase 2b clinical trial of MDR-001, a novel small-molecule oral GLP-1RA drug designed with AI assistance and independently developed, has been completed.
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) Assisted Reproductive Technology Included in Medical Insurance in Multiple Provinces and Cities
On October 10, according to the official WeChat account of the National Healthcare Security Administration, Hunan, Shanxi, and Sichuan provinces have included assisted reproductive technologies within the scope of medical insurance coverage.
/ 02 /
Capital Information
1) Hubei Xinzongke Completes Tens of Millions of Yuan in B-Round Financing
On October 10, Hubei Xinzongke announced the completion of a B-round financing worth tens of millions of RMB. This round of financing will further accelerate the application innovation and commercial promotion of flow fluorescence technology, providing more customers with high-performance and cost-effective one-stop product solutions and services for flow fluorescence.
/ 03 /
Pharma Dynamics
1) Hengrui Pharma's Albumin-Bound Paclitaxel Approved for Marketing in the United States
On October 10, Hengrui Pharma announced that its ANDA (Abbreviated New Drug Application, or generic drug application in the U.S.) for Paclitaxel Injection (Albumin-Bound) had been approved by the FDA. It is the first company to receive U.S. approval for a generic version of this product.
2) MindRank's Oral GLP-1 New Drug Completes First Dose Group Administration in Phase 2b Study
On October 10, MindRank announced that the first dosing group in the Phase 2b clinical trial of MDR-001, a novel small-molecule oral GLP-1RA drug designed with AI assistance, has been completed.
3) Pfizer’s EZH2 Inhibitor Enters Phase 3 Clinical Trial
Recently, according to the official website of the Chinese Clinical Trial Registry and Information Disclosure Platform, Pfizer has initiated an international multi-center (including China) Phase 3 clinical study (MEVPRO-1) of an EZH2 inhibitor. This study aims to evaluate the efficacy and safety of PF-06821497 combined with enzalutamide versus enzalutamide or docetaxel in patients with metastatic castration-resistant prostate cancer who have previously received abiraterone acetate treatment.
/ 04 /
Instrument Tracking
1) GE Patient Monitor Registration Terminated
On October 10, according to the NMPA website, GE Healthcare's patient monitor registration was terminated.
2) Jinhao Pharmaceutical Blood Type Identification and Irregular Antibody Screening Quality Control Products Not Registered
On October 10, according to the NMPA website, Jinhao Pharmaceutical's blood type identification and irregular antibody screening quality control products did not obtain registration approval.
3) Weilang Medical Peripheral Thrombus Aspiration Catheter Receives Registration Approval
On October 10, according to the NMPA website, Wellong Medical's peripheral thrombus aspiration catheter received registration approval.
/ 05 /
Digital Healthcare Daily
1) DeepRui BoLian's Pediatric Hand X-ray Bone Age Assessment Software Receives Registration Approval
On October 10, according to the NMPA website, Deepwise Biomedical's pediatric hand X-ray bone age assessment software received registration approval.
/ 06 /
Global Pharma News
1) Johnson & Johnson Completes Major Acquisition
On October 9, Johnson & Johnson announced the completion of its acquisition of V-Wave, a manufacturer of atrial shunt devices. Under the agreement, Johnson & Johnson will pay V-Wave an upfront payment of $600 million. In addition to the upfront payment, Johnson & Johnson is also required to pay potential additional regulatory and commercial milestone payments, bringing the total amount to approximately $1.7 billion.
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