▎Yi Yao Guan Lan/Report
Today’s Progress in Domestic Innovative Drug R&D.
1. Major Progress Achieved in Zhenbaodao's Innovative Drug R&D
Recently, Heilongjiang Zhenbaodao Pharmaceutical Co., Ltd. announced that its subsidiary, Harbin Zhenbao Pharmaceutical Co., Ltd. (“Harbin Zhenbao”), had received the “Notice of Acceptance” from the National Medical Products Administration for HZB0071, a Class 1 innovative drug with independent intellectual property rights, which is an AKT kinase inhibitor.
It is reported thatAKT Kinase Inhibitors Have Become One of the Hotspots in Antitumor Drug Development.Studies have shown that AKT, as a key molecule in the PI3K/AKT/mTOR cell survival pathway, plays a central role in promoting cell growth and proliferation, enhancing cell motility and invasion, inhibiting apoptosis, promoting angiogenesis, and conferring resistance to chemotherapy and radiotherapy.
Currently, there are no marketed AKT kinase inhibitors. Investigational drugs targeting the same class include the ATP-competitive AKT inhibitors GDC-0068 (Roche), AZD5363 (AstraZeneca), and GSK2110183 (Novartis), all of which are undergoing Phase II/III clinical trials.
HZB0071, an anti-tumor targeted AKT kinase inhibitor subject to this registration application, is the first innovative drug developed by Zhenbaodao.This underscores the company’s focus on major diseases such as cancer. Currently, Zhenbaodao has 18 chemical drug projects under development, primarily comprising new chemical entities and generic drugs. The R&D portfolio covers therapeutic areas including cardiovascular and cerebrovascular diseases, malignant tumors, hepatitis, diabetes, antiviral therapies, gynecology, orthopedics, and rheumatoid arthritis.
2. Zhongsheng Pharmaceutical’s Class 1 Innovative Targeted Drug Approved for Clinical Trials
Recently, Guangdong Zhongsheng Pharmaceutical Co., Ltd. announced that its ZSP1241 product had received the “Drug Clinical Trial Approval” issued by the National Medical Products Administration.
ZSP1241 is a small-molecule targeted drug with independent intellectual property rights, developed by Zhongsheng Pharmaceutical for liver cancer and gastric cancer targeting specific driver genes.Preclinical study results demonstrate that ZSP1241 exhibits potent efficacy both in vitro and in vivo, showing significant antitumor activity in various hepatocellular carcinoma and gastric cancer CDX or PDX models, and synergistic effects when combined with sorafenib, the first-line therapy for liver cancer. GLP toxicology studies indicate that ZSP1241 has a favorable safety profile and a wide therapeutic window.
3. CSPC Pharmaceutical Group and Junshi Biosciences Collaborate to Develop PD-1 Monoclonal Antibody Combination Therapy
On July 10, CSPC Pharmaceutical Group announced the execution of a product co-development and strategic cooperation agreement with Shanghai Junshi Biosciences Co., Ltd. Pursuant to the agreement,Junshi Biosciences' Independently Developed Recombinant Humanized Anti-PD-1 Monoclonal Antibody(Product code “JS001”) and CSPC Pharmaceutical Group’s approved paclitaxel for injection (albumin-bound) (hereinafter referred to as “albumin-bound paclitaxel”)Collaborate on the clinical development, registration, and commercialization of combination therapies for breast cancer.
It is reported that the two parties have reached detailed agreements on clinical development, technology licensing, intellectual property rights, and sales-based milestone payments. CSPC Pharmaceutical Group will pay Junshi Biosciences up to RMB 150 million.
CSPC Pharmaceutical Group is one of the well-known listed pharmaceutical companies in Hong Kong, primarily engaged in the development, production, and sales of pharmaceuticals and related products. Shanghai Junshi Biosciences Co., Ltd. is a research-driven high-tech company focused mainly on the development of therapeutic antibodies. It currently has more than ten products in its pipeline, primarily covering areas such as oncology, cardiovascular diseases, and osteoporosis.
4. Adlai Nortye Biopharma Acquires Exclusive Global Rights to Develop and Market the Oncology Drug Buparlisib
On July 10, Adlai Nortye Biopharma Co., Ltd. announced that it had signed a global licensing agreement with pharmaceutical giant Novartis AG in Hangzhou, granting Adlai Nortye the exclusive worldwide rights to develop, manufacture, and commercialize the oncology drug Buparlisib (BKM120) (AN2025), through upfront payments, milestone payments, and sales royalties.
Buparlisib (BKM120) (AN2025) is an oral pan-PI3K inhibitor with immuno-oncology (I/O) activity, which has demonstrated clinical efficacy in patients with solid tumors and hematologic malignancies.The global Phase 2 clinical trial of combination therapy with paclitaxel for the treatment of head and neck squamous cell carcinoma has been completed, demonstrating manageable drug safety, and Fast-Track designation has been granted by the U.S. FDA.
Lu Yang, Chairman and Chief Executive Officer of Adlai Nortye Biopharma, stated, “This product is a blockbuster novel drug that has undergone years of research and clinical trials by top-tier international pharmaceutical companies. Its safety profile can be effectively managed, and certain clinical efficacies have already been validated. Upon introduction, it will become one of the company’s flagship products. Buparlisib (BKM120) (AN2025) holds significant potential in the treatment of various cancers and in combination therapies with paclitaxel and PD-1 inhibitors, offering broad market prospects.”
Adlai Nortye is an emerging innovator in the domestic pharmaceutical R&D sector, with a therapeutic focus on cancer immunotherapy. The company recently completed a Series B financing round exceeding USD 50 million, with participation from Yuanming Capital, Matrix Partners China, DT Capital Partners, and Yahui Investment. Adlai Nortye currently has more than 10 products in its pipeline, two of which are in clinical development: Reolysin, a globally leading oncolytic virus administered via intravenous injection, is poised to enter Phase III clinical trials; and AN0025, a tumor immunotherapy EP4 antagonist with one of the fastest global development timelines, is currently in Phase Ib clinical trials in Europe and the United States.
References:
[1] Company Announcements and Official Websites
