Sound Biologics' PD-1/CTLA-4 Bispecific Antibody QL1706 Approved in China Within 14 Months of NDA Submission

Oct 13, 2024 09:44 CST Updated 09:45

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Sound Biologics

QL1706 (PSB205 Project) is a bifunctional combination antibody developed by Qilu Pharmaceutical, which can simultaneously inhibit the PD-1 and CTLA-4 pathways. It utilizes a novel combination antibody technology platform.MabPair, inSimultaneous production of two engineered monoclonal antibodies in a single cell at a ratio of approximately 2:1, namely PD-1 IgG4 antibody Iparomlimab and CTLA-4 IgG1 antibody Tuvonralimab.Relevant Patent WO-2022178319On August 12, 2023, the first NDA/BLA for a new drug indication in China was submitted for this product. This product was initially developed by Qilu US Sound Biologics/Pushang Biopharmaceuticals in the United States.

On September 30, 2024, the PD-1/CTLA-4 bispecific antibody Ipaprelimab-Tovorolimab Injection (brand name: Qibean, code: QL1706) developed by Qilu Pharmaceutical Co., Ltd. was approved for marketing by the China National Medical Products Administration (NMPA): indicated for the treatment of patients with recurrent or metastatic cervical cancer who have failed prior platinum-based chemotherapy. (The approval came in under 14 months from submission.)

From the morning of October 8, 2024, upon learning that the NMPA approval document had arrived, various departments of Qilu Pharmaceutical Research Institute—including production, quality, sales, and logistics—worked tirelessly and cooperated efficiently. From finalizing and printing packaging materials to coordinating deliveries, from workshop equipment debugging and production assurance to testing, release, and planning shipment arrangements, the first batch of Eparlolib-Tovorilib Monoclonal Antibody Injection was shipped within two days of receiving the approval.

Qilu US Sound Biologics, U.S. Qilu Pushang Biopharmaceuticals

MabPair Combination Antibody Technology Platform

At the 2024 CSCO Annual Meeting in September, the results of the first-line treatment with the PD-1/CTLA-4 bifunctional antibody Aipalolitovorelimab (QL1706) combined with bevacizumab and/or chemotherapy for advanced hepatocellular carcinoma were presented orally.

Dr. Wei Yan, Founder and President of Qilu Prushen Biopharmaceuticals in the United States. He graduated with a bachelor's degree in Cell Biology from Peking University. After studying abroad in the U.S., he earned his Ph.D. from the Weill Cornell Medical College in New York. Since then, he has been working in the biopharmaceutical industry, holding positions at Schering AG's California R&D department in Germany, Immunex Corporation in Seattle, USA, and Amgen Inc. With over twenty years of experience in biopharmaceutical research and development, he spent fourteen years at Amgen as the Director of Antibody Engineering R&D, responsible for large-molecule drug design and screening. He has participated in the research and development of antibody drugs in multiple fields including cancer, inflammation, lipid-lowering, and metabolic improvement.

Dr. Yan Wei also led the team to develop a new generation of bispecific antibody technology (Amgen’s charge-pair Fc heterodimer).Cooperation with Qilu Pharmaceutical in 2015Founded Qilu Pushang Biopharmaceuticals in the United States and developed the next-generation dual-antibody combination MabPair technology platform.

https://www.soundbiologics.com/our-science/platform-technologies/mabpair/

Sound Biologics/Qilu Pushang Biopharmaceuticals Co., Ltd. Additionally, the products under development include: PSB114, an ADCC-enhanced humanized monoclonal antibody targeting CCR8, used to block CCL1-mediated Tregs chemotaxis and deplete tumor-associated CCR8-expressing Tregs. Other molecules in the pipeline include HER2 bispecific antibody, CSF-1R, PD-1 (BLA), and more.

Top pharmaceutical companies in China

Qilu Pharmaceutical currently has 38,000 employees. Its drug research and development system boasts a team of 4,400 people. It includes core technology platforms such as small-molecule drug precise design platforms, protein degradation, monoclonal antibodies, bispecific antibodies, antibody combinations (MabPair), oncolytic viruses, ADC technology platforms, nanomedicine delivery, mRNA, and siRNA. Qilu has established a comprehensive innovative drug pipeline in major unmet disease areas such as oncology, infectious diseases, liver diseases, autoimmune diseases, and metabolic disorders.R&D investment in the past five years: 13.68 billion RMB。

Previously, Regor Pharma, which generated mega transactions, was also one of the companies participated by Qilu Pharmaceutical.$850 Million in Cash! Rigel Pharmaceuticals' CDK Drug Licensed to Roche Genentech。

Reference:

NMPA/CDE；

Pharnex Cloud Data www.pharnexcloud.com;

FDA/EMA/PMDA；

Relevant companies publicly disclosed;

https://www.soundbiologics.com/；

Qilu Pharmaceutical, https://www.qilu-pharma.com/;

2024 CSCO | Professor Shukui Qin: PD-1/CTLA-4 Dual Immunotherapy Antibody QL1706 Combined with Targeted Therapy and Chemotherapy for First-Line Treatment of Liver Cancer;

https://www.qilu-pharma.com/news_details/390.html; etc.

This article is intended to provide scientific information to healthcare professionals only, does not represent the platform's position, and does not recommend any medication.