Sanofi's BTK Inhibitor Succeeds in Phase III Autoimmune Trial; Simcere Inks Deal for Tagri's ALK/ROS1 Inhibitor TGRX-326
Sanofi
Pharmaceutical Manufacturer
Simcere
Innovative Drug Developer
Hengrui Pharma
Innovative and High-Quality Pharmaceutical Developer
Grit Biotherapeutics
Developer of Immunotherapy Drugs for Solid Tumors
© Amino Observation - Innovative Drug Team Original Production
Author | Huang Kai
BTK Takes Another Step Forward in the Field of Autoimmune Indications.
On September 2, Sanofi announced that its BTK inhibitor, tolebrutinib, achieved positive results in the HERCULES Phase 3 study, demonstrating that tolebrutinib significantly delayed the time to confirmed disability progression in patients with non-relapsing secondary progressive multiple sclerosis, reaching the primary endpoint superior to placebo.
Simcere Accelerates the Introduction of New Drugs.
On September 2, Simcere announced that its subsidiary, Simcere Zaiming, had signed a cooperation agreement with TagRx regarding TGRX-326, a clinical-stage anti-tumor candidate drug and ALK/ROS1 dual receptor tyrosine kinase inhibitor. According to the agreement, Simcere Zaiming will obtain the exclusive commercial rights for TGRX-326 in China, while TagRx will receive an upfront payment of over 20 million US dollars and will pay Simcere Zaiming a promotion service fee.
Hengrui Pharma's Recombinant Trastuzumab Proposed for Priority Review
On September 2, according to the CDE official website, Hengrui Pharma's Recombinant Trastuzumab was proposed for inclusion in the priority review process. Its indication is for the treatment of adult patients with locally advanced or metastatic HER2-mutated non-small cell lung cancer who have previously received at least one systemic therapy.
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) Simcere introduces TGRX ALK/ROS1 inhibitor
On September 2, Simcere announced that its subsidiary, Simcere Zaiming, entered into a cooperation agreement with TargetRx regarding the clinical-stage anti-tumor candidate drug TGRX-326, an ALK/ROS1 dual receptor tyrosine kinase inhibitor. Simcere Zaiming will obtain the exclusive commercialization rights of TGRX-326 in mainland China, while TargetRx will receive an upfront payment of over 20 million US dollars and will pay promotional service fees to Simcere Zaiming.
/ 02 /
Pharmaceutical News
1) Simcere's Xianbi New Sublingual Tablets Receive FDA Breakthrough Therapy Designation
On September 2, Simcere announced that the investigational innovative stroke drug, Xianbi Xin sublingual tablets, developed in collaboration with Ningdan New Drug, received FDA Breakthrough Therapy Designation for the treatment of acute ischemic stroke.
2) AccuRigen's ART001 Receives FDA Approval for Clinical Trials
On September 2, Raygen Gene announced that the FDA has approved the clinical trial of ART001, an in vivo gene editing drug using non-viral vectors, targeting transthyretin amyloidosis (ATTR).
3) Gravel Biotech's TIL Therapy Receives FDA Clinical Approval
On September 1, Grail Bio announced that GT201 injection, a tumor-infiltrating lymphocyte (TIL) therapy, has been approved by the U.S. FDA for clinical trials.
4) Sanofi's Irbesartan and Hydrochlorothiazide Tablets Proposed for Priority Review
On September 2, according to the CDE official website, Sanofi's Irbesartan Hydrochlorothiazide Tablets are proposed for priority review, with the indication being essential hypertension.
5) Bayer's Rivaroxaban Tablets Proposed for Priority Review
On September 2, according to the CDE website, Bayer's Rivaroxaban Tablets are proposed for inclusion in the priority review, indicated for adult patients with coronary artery disease (CAD) at high risk of ischemic events to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke).
6) Hengrui Pharma's Trastuzumab拟纳入Priority Review
On September 2, according to the CDE website, Hengrui Pharma's Recombinant Trastuzumab is proposed for priority review. The indication is for the treatment of adult patients with locally advanced or metastatic HER2-mutated non-small cell lung cancer who have previously received at least one systemic therapy.
7) XNW5004 Tablets by SignaPharm to Receive Breakthrough Therapy Designation
On September 2, according to the CDE website, XNW5004 Tablets developed by Xennovate Pharma are proposed to receive Breakthrough Therapy Designation for the treatment of relapsed or refractory peripheral T-cell lymphoma.
8) Henlius' PD-1 Inhibitor Pembrolizumab Biosimilar Approved for Clinical Trials
On September 2, Henlius announced that the biosimilar of Pembrolizumab, HLX17, has been granted clinical approval and is intended for all indications approved in China for the original Pembrolizumab.
9) Quidex Pharmaceuticals' Next-Generation HER2 ADC GQ1005 Approved for Phase III Clinical Trial
On September 2, QuidMed announced that the new generation of HER2-targeted ADC drug GQ1005 has been approved for clinical trials, and a Phase III clinical trial is planned to treat HER2-positive inoperable/metastatic breast cancer patients.
10) Bayer's BAY 2927088 Tablets Receive Clinical Approval
On September 2, according to the CDE website, Bayer's BAY 2927088 tablet received clinical approval for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying HER2 activating mutations.
11) Hengrui Pharma's HW071021 Tablet Receives Clinical Approval
On September 2, according to the CDE website, Renfu Innovation's HW071021 tablet received clinical approval and is proposed to conduct research for the treatment of advanced solid tumors.
12) Sinocelltech's SCT520FF Injection Receives Clinical Approval
On September 2, according to the CDE website, Sinocelltech's SCT520FF injection has been granted clinical approval for the proposed study on treating neovascular age-related macular degeneration.
/ 03 /
Instrument Tracking
1) Hengrui Pharma's Yida PTA Guidewire Not Registered
On September 2, according to the NMPA website, Hexin Yida PTA guidewire was not registered.
2) Silicon-based sensing continuous glucose monitoring system receives registration approval
On September 2, according to the NMPA website, Silicon-Based Sensing's Continuous Glucose Monitoring System received registration approval.
3) Asian Bio-Artificial Bone Repair Material Receives Registration Approval
On September 2, according to the NMPA website, Asian Bio artificial bone repair materials received registration approval.
4) Peijia Medical's Transcatheter Aortic Valve System Receives Registration Approval
On September 2, according to the NMPA website, Peijia Medical's transcatheter aortic valve system received registration approval.
5) New Industry Ophthalmology's Rigid Gas-Permeable Contact Lens for Corneal Reshaping Receives Registration Approval
On September 2, according to the NMPA website, New Industry Ophthalmology's rigid gas-permeable contact lens for orthokeratology received registration approval.
6) Yodobang Medical's Paclitaxel-Coated Coronary Balloon Dilatation Catheter Receives Registration Approval
On September 2, according to the NMPA website, Youdebang Medical's Paclitaxel-Coated Coronary Balloon Dilatation Catheter received registration approval.
7) Minimally Invasive Orthopedic Artificial Knee Joint System Receives Registration Approval
On September 2, according to the NMPA website, the MicroPort Orthopedics artificial knee joint system received registration approval.
/ 04 /
Digital Healthcare Daily
1) Major Adjustment in Alibaba Health's Senior Management
On August 30, Alibaba Health announced on the Hong Kong Stock Exchange that Zhu Shunyan, an executive director of the company, will be transferred from executive director to non-executive director due to his intention to devote more time to the group's overall strategic planning and industry development research. The change will take effect on September 1, 2024. After the transfer, Zhu Shunyan will continue to serve as chairman of the board and chairman of the company’s nomination committee.
/ 05 /
Overseas Pharmaceutical News
1) Sanofi's BTK Inhibitor Tolebrutinib Meets Primary Endpoint in Phase III Trial for nrSPMS
On September 2, Sanofi announced that the positive results of the Phase 3 HERCULES study of the BTK inhibitor tolebrutinib showed that tolebrutinib achieved a primary endpoint superior to placebo in delaying the onset of confirmed disability progression in patients with non-relapsing secondary progressive MS.
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