Rocbrutinib (LP-168), a Next-Generation BTK Inhibitor, Advances Clinical Development with Strategic Partnership and Breakthrough Therapy Designation

Aug 13, 2024 10:06 CST Updated 10:06

Lupeng Pharmaceutical

Developer of New Anticancer Drugs

Hansoh Pharma

Pharmaceutical Research, Production, and Sales

Haoyue Values

MissionEmpower with Capital, Achieve Excellence in Healthcare Enterprises

VisionTo become the most outstanding investment bank in China's healthcare industry

HaoYue Capital, founded in January 2014, is a leading investment bank in China that focuses on the healthcare industry. The company's headquarters is located in Shanghai, with regional offices established in Beijing, Shenzhen, and Hong Kong. HaoYue Capital has always been committed to assisting with capital and driving research efforts, helping outstanding companies in China’s medical industry successfully connect with the capital markets while creating added value for clients. The partnership team at HaoYue Capital consists of senior investment bankers with years of deep involvement in China’s healthcare sector. HaoYue Capital continuously tracks market dynamics and investment trends in healthcare closely. Its research and transaction scope covers multiple subfields such as innovative pharmaceuticals, cutting-edge medical devices, IVD and life sciences, health services, and smart healthcare. As of 2023, HaoYue Capital has completed nearly 400 projects with a cumulative transaction value exceeding tens of billions of US dollars; among these, it completed over 50 mergers and acquisitions, amounting to more than 50 billion US dollars in total transaction value. In 2023, HaoYue Capital completed nearly 50 private equity financings, M&A integrations, and complex transactions involving listed companies, with a total transaction value reaching several billion US dollars, maintaining its comprehensive leadership across various subfields of the healthcare industry.

RecentlyDay,Lupeng Pharmaceutical and Hansoh Pharma have reached a collaboration on the development, registration, and commercialization of LP-168 (Lobrutinib, Rocbrutinib) for non-oncology indications in China (including Hong Kong, Macao, and Taiwan). The deal is worth 729 million RMB and includes tiered royalties of up to double digits based on future net product sales. Lobrutinib is a small molecule Bruton's Tyrosine Kinase inhibitor (BTKi) independently developed by Lupeng Pharmaceutical, which owns the intellectual property rights globally, including in China.

Lobutinib, designed with a creative approach, has a unique mechanism of action. It is the world's first covalent and non-covalent BTK inhibitor, capable of binding to both wild-type and drug-resistant mutant BTK, thereby inhibiting the B-cell receptor signaling pathway and blocking the abnormal proliferation, differentiation, and survival of B lymphocytes. Lobutinib can not only overcome the drug resistance of 1st/2nd/3rd generation BTK inhibitors but also shows an order-of-magnitude improvement in activity, selectivity, and pharmacokinetics (PK), making it a promising Best-in-Class next-generation BTKi.

In addition to non-cancer indications such as autoimmune diseases, the main clinical research indications currently underway for Lobutinib focus on various types of relapsed/refractory B-cell lymphomas. These include relapsed/refractory (R/R) adult mantle cell lymphoma (R/R MCL), chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL), marginal zone lymphoma (R/R MZL), and diffuse large B-cell lymphoma (R/R DLBCL). For relapsed/refractory non-germinal center diffuse large B-cell lymphoma (R/R non-GCB DLBCL), Lobutinib has demonstrated particularly outstanding efficacy compared to other therapies. In May 2024, it was designated as a breakthrough therapy by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), marking it as the first BTK inhibitor (BTKi) recognized in China as a breakthrough therapy for DLBCL.

Lobutinib's pivotal registration study was approved by the CDE in September 2023 and is currently being conducted across 41 centers in China. The clinical trial is proceeding smoothly, with hopes to complete the study in the near future and submit a New Drug Application (NDA) for production and marketing approval.

Lobutinib, as a new generation BTK inhibitor, has demonstrated excellent efficacy and safety in the treatment of hematological tumors, offering new options and hope for patients!

About Lupeng Pharmaceutical

Lupeng Pharmaceutical was co-founded by Dr. Fenlai Tan and Dr. Yi Chen in Guangzhou in June 2018. The company focuses on the research and development of innovative drugs for malignant tumors, autoimmune diseases, and other conditions that seriously affect human life and health. It targets key areas such as BTK, Bcl-2, and Bcl-xL in hematological malignancies, with a comprehensive layout for international and domestic multi-center clinical development and commercialization. Lupeng's R&D pipeline includes over 10 projects, among which the core projects Rocbrutinib (LP-168) and Lacutoclax (LP-108) have been approved by the National Medical Products Administration (NMPA) for pivotal registrational studies. Rocbrutinib, Lacutoclax, and LP-118 are highly competitive in the industry and are expected to become Best-in-Class products. Since its establishment, the company has continuously received investments and support from multiple international and domestic biopharmaceutical venture capital funds. Upholding the principles of "Diligence, Pragmatism, Innovation, and Serving Humanity," Lupeng Pharmaceutical is committed to building a multinational pharmaceutical enterprise that integrates R&D, production, and sales, with strong innovation capabilities and social responsibility, headquartered in the Greater Bay Area.

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