Zai Lab's KarXT Succeeds in China Phase 3 Trial; Novartis' Scemblix Receives FDA Approval for First-Line Treatment of Ph+ Chronic Myeloid Leukemia
Zai Lab
Innovative Global Biopharmaceutical Company
GSK
Pharmaceutical R&D Manufacturer
Endovastec
Developer and Manufacturer of Aortic and Peripheral Vascular Interventional Medical Devices
Xingqi Pharmaceutical
Ophthalmic Drug Research, Development, Production, and Sales
Hengrui Pharma
Innovative and High-Quality Pharmaceutical Developer
Amino Observation - Original Production by the Innovative Drug Team
Author | Huang Kai
Zai Lab's Major Pipeline Expansion Imminent.
On October 29, Zai Lab announced the primary data from the Phase 3 bridging study of KarXT for the treatment of schizophrenia in China. The results were consistent with previous global clinical studies.
This registrational bridging study met its primary endpoint, demonstrating a statistically significant 9.2-point reduction from baseline in the Positive and Negative Syndrome Scale total score at week five for KarXT compared to placebo.
Zai Lab stated that it is actively advancing and plans to submit a new drug marketing application for KarXT to the NMPA in early 2025.
Novartis Receives Good News.
On October 29, Novartis announced that Scemblix received accelerated approval from the FDA for the treatment of newly diagnosed adult patients with chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP).
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) Chimagen Biosciences' Triple Antibody Autoimmune New Drug Acquired by GSK
On October 29, Chimagen Biosciences' CD19 and CD20-targeted T-cell engager was acquired by GSK. GSK plans to develop and commercialize CMG1A46 for B-cell-driven autoimmune diseases such as systemic lupus erythematosus (SLE) and lupus nephritis (LN), with the potential to expand into related autoimmune conditions. Under the terms of the agreement, GSK will make an upfront payment of $300 million to obtain full global rights to CMG1A46. Additionally, Chimagen Biosciences is eligible to receive development and commercialization milestone payments totaling $550 million.
/ 02 /
Capital Information
1) United Imaging Healthcare's Net Profit in the First Three Quarters Decreased by 36.94% Year-on-Year
On October 30, United Imaging Healthcare released its third-quarter report for 2024. In the first three quarters, the company achieved operating revenue of 6.954 billion yuan, a year-on-year decrease of 6.43%; net profit attributable to shareholders of the listed company was 671 million yuan, a year-on-year decrease of 36.94%.
2) Endovastec's Net Profit in the First Three Quarters Increased by 42.46% Year-on-Year
On October 29, Endovastec released its Q3 2024 earnings report. In the first three quarters, the company reported a revenue of 969 million yuan, representing a year-on-year increase of 9.13%; net profit reached 553 million yuan, marking a year-on-year growth of 42.46%.
/ 03 /
Pharmaceutical News
1) Xingqi Pharmaceutical Withdraws the Registration Application for Timolol Maleate Eye Drops
On October 30, Xingqi Pharmaceutical announced that the company had received the "Notice of Termination of Drug Registration Application" issued by the National Medical Products Administration, approving the withdrawal of the registration application for Timolol Maleate Eye Drops.
2) Hengrui Pharma Initiates Phase 3 Clinical Study in China for Complement Factor B Inhibitor
Recently, the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform showed that Hengrui Pharma has initiated the Phase 3 clinical study in China for HRS-5965, a complement factor B inhibitor, to evaluate the efficacy and safety of the drug in treating patients with paroxysmal nocturnal hemoglobinuria.
3) Zai Lab's New Schizophrenia Drug Meets Primary Endpoint in China Phase 3 Study
On October 29, Zai Lab announced the primary data from the Phase 3 bridging study of KarXT for the treatment of schizophrenia in China. Consistent with prior global clinical studies, this registrational bridging study met its primary endpoint, demonstrating a statistically significant 9.2-point reduction from baseline in the Positive and Negative Syndrome Scale total score at week five compared to placebo. Zai Lab stated that it is actively advancing its plans and intends to submit a New Drug Application for KarXT to the NMPA in early 2025.
/ 04 /
Instrument Tracking
1) Lifetech Peripheral Thrombus Aspiration Catheter Registration Terminated
On October 30, according to the NMPA website, Lifetech Scientific's peripheral thrombus aspiration catheter registration was terminated.
2) Chimagen Biosciences Group A Streptococcus Antigen Test Kit (Immunochromatography) Ceases Registration
On October 30, according to the NMPA website, Chimagen Biosciences' Group A Streptococcus Antigen Test Kit (Immunochromatographic Assay) ceased registration.
/ 05 /
Overseas Pharmaceutical News
1) Novartis' Scemblix Approved for First-Line Treatment of Ph+ Chronic Myeloid Leukemia
On October 29, Novartis announced that Scemblix received accelerated approval from the FDA for the treatment of newly diagnosed adult patients with chronic-phase Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML-CP).
2) DS8201 Submits New Indication for Market Application
On October 29, the supplemental Biologics License Application (sBLA) for trastuzumab deruxtecan, co-developed by Daiichi Sankyo and AstraZeneca, was accepted by the U.S. FDA and granted Priority Review. The application is for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membranous staining) breast cancer who have received at least one prior endocrine therapy in the metastatic setting.
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