Janssen's Pan-FGFR Inhibitor Erdafitinib Approved in China; Global Second PROTAC Drug Enters Phase III
Johnson & Johnson
Medical Device R&D and Manufacturer
WuXi AppTec
New Drug R&D and Production Service Provider
3SBIOINC
Biopharmaceutical Manufacturer
DualityBio
Innovative Molecular Type Drug Developer
Huadong Medicine
Large Comprehensive Pharmaceutical Product Developer
Amino Observation - Original Production by the Innovative Drug Team
Author | Huang Kai
Johnson & Johnson's New Developments in China.
On January 13, Johnson & Johnson announced that the FGFR inhibitor Erdafitinib tablets received NMPA approval for marketing in China. It is indicated for the treatment of adult patients with surgically unresectable locally advanced or metastatic urothelial carcinoma who harbor susceptible FGFR3 genetic alterations and have experienced disease progression during or after at least one prior line of therapy containing anti-PD-1 or anti-PD-L1.
Bristol-Myers Squibb Makes Another Move.
Recently, according to the Clinicaltrials website, Celgene, a subsidiary of Bristol-Myers Squibb, has launched the first Phase III clinical trial of BMS-986365. This is the world's second PROTAC (Proteolysis Targeting Chimera) drug to enter the Phase III stage, and it is also the first PROTAC drug targeting the androgen receptor (AR) to reach this stage.
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) WuXi AppTec Sells 7.17% Stake in WuXi XTL Biologics, Realizing Cumulative Investment Gains of RMB 2.016 Billion
On January 13, WuXi AppTec announced that on November 8, 2024, and January 10, 2025, through two block trades, the company had cumulatively sold 86 million shares of WuXi XTL Biologics, accounting for approximately 7.17% of WuXi XTL Biologics' current total share capital. The cumulative transaction amount was about 2.426 billion Hong Kong dollars. Over the past twelve months, the investment income realized from the sale of WuXi XTL Biologics shares amounted to RMB 2.016 billion.
2) 3SBIOINC and Duality Biologics Reach Collaboration on HER2 ADC
On January 13, 3SBio Group, a subsidiary of 3SBIO INC, announced that it had reached a cooperation agreement with Duality Biologics regarding the HER2 ADC drug DB-1303. According to the agreement, 3SBio Group will obtain the commercialization rights for multiple indications of the HER2 ADC drug DB-1303 developed by Duality Biologics in mainland China, Hong Kong, and Macao. Duality Biologics will receive an upfront payment of 25 million US dollars that cannot be refunded, and in the future, Duality Biologics is eligible to receive up to 42 million US dollars in research and development milestones, as well as potential additional sales milestone payments.
/ 02 /
Capital Information
1) Mira Completes $40 Million Strategic Financing
On January 13, miRNA technology and cancer liquid biopsy pioneer Mirxes announced a strategic financing of 40 million US dollars with C-Bridge Credit Fund under C-Bridge Capital to support the rapid growth of Mirxes and its expansion in major global markets.
/ 03 /
Pharmaceutical News
1) Runshi Pharmaceutical's SYHA1813 Oral Solution Receives Clinical Approval
On January 13, according to the CDE official website, Runde Medicine's SYHA1813 oral solution received clinical approval and is proposed for combination therapy to treat solid tumors and hematological malignancies.
2) Huadong Medicine HDM2006 Tablet Receives FDA Clinical Trial Approval
On January 13, Huadong Medicine announced that the FDA has approved the Phase I clinical trial of PROTACHDM2006 tablets, a novel, potent, highly selective, and orally absorbable drug targeting HPK1, for the planned research on treating advanced malignant tumors and more.
3) HUTCHMED Savolitinib Approved for New Indication
On January 13, according to the NMPA website, HUTCHMED's Savolitinib tablet has been approved for a new indication, intended for the treatment of previously untreated MET exon 14 skipping mutation non-small cell lung cancer (NSCLC) patients.
4) Johnson & Johnson's Pan-FGFR Inhibitor Erdafitinib Approved for Marketing
On January 13, Johnson & Johnson announced that the FGFR inhibitor Erdafitinib tablets received NMPA approval for marketing in China. It is indicated for the treatment of adult patients with surgically unresectable locally advanced or metastatic urothelial carcinoma who harbor susceptible FGFR3 gene alterations and have experienced disease progression during or after at least one prior line of therapy containing anti-PD-1 or anti-PD-L1.
/ 04 /
Device Dynamics
1) Balloon Ren Medical Atrial Septal Occluder Obtains Registration Approval
On January 13, according to the NMPA website, Balloon Medical's atrial septal defect occluder received registration approval.
2) Chunli Zhengda Medical's Unicompartmental Knee Arthroplasty Navigation System Receives Registration Approval
On January 13, according to the NMPA website, Chunli Zhengda Medical's unicompartmental knee replacement surgical navigation system received registration approval.
3) Emmi Intelligent Puncture Surgical Navigation and Positioning System Obtains Registration Approval
On January 13, according to the NMPA website, the Aimit Intelligent Puncture Surgical Navigation and Positioning System obtained registration approval.
4) Puncture Follicle Extraction Device Receives Registration Approval
On January 13, according to the NMPA website, the Puncture Medical follicle extraction device received registration approval.
5) Tongling Biomimetic Technology's Intra-Aortic Balloon Pump Receives Registration Approval
On January 13, according to the NMPA website, Tongling Biomimetic Technology's intra-aortic balloon pump received registration approval.
/ 05 /
Overseas Pharmaceutical News
Over $10 Billion! Johnson & Johnson Plans to Acquire CNS Pharma Company Intra-Cellular
On January 13, according to foreign media reports, Johnson & Johnson is considering acquiring Intra-Cellular Therapies, a central nervous system (CNS) pharmaceutical company with a market value of approximately $10 billion. Insiders say this acquisition deal could be reached as early as this week.
2) The Second PROTAC Drug Globally Enters Phase III Stage
Recently, according to the Clinicaltrials website, Celgene has initiated the first Phase III clinical trial of BMS-986365. This is the world's second PROTAC (Proteolysis Targeting Chimera) drug to enter the Phase III stage, and also the first PROTAC drug targeting the androgen receptor (AR) to reach this stage.
PS: Welcome to scan the QR code below to add the WeChat ID of Anji Jun for communication.
