ShiPharma's Oncology Drug Nominated for Breakthrough Therapy, AstraZeneca Acquires Roxadustat Rights for $160M, and CXO Leader Acquires AI Firm

Feb 23, 2025 09:23 CST Updated 09:23

CSPC

Innovative Drug Research and Development, Manufacturer

GSK

Pharmaceutical R&D Manufacturer

Huadong Medicine

Large Comprehensive Pharmaceutical Product Developer

Weekly Highlights Review

CSPC's New Anti-Tumor Drug Proposed for Inclusion in Breakthrough Therapy Category

On February 20, the official website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration announced that an injection of Sirolimus (albumin-bound) submitted by CSPC under Registration Category 2.2 is proposed to be included in the breakthrough therapy designation for the treatment of malignant perivascular epithelioid cell tumors.

Sirolimus, also known as rapamycin, is a commonly used specific mTOR inhibitor. According to public information from CSPC, its injectable sirolimus (albumin-bound type) uses special technology to encapsulate sirolimus within human serum albumin, enabling the intravenous administration of sirolimus without the need for pre-treatment with hormones, while also expanding the application scope of this drug.

Potential First! GSK's "Mepolizumab" Another Indication Submitted for Marketing in China

On February 20, GSK announced that China's NMPA has accepted a new indication application for mepolizumab injection for the maintenance treatment of chronic obstructive pulmonary disease (COPD) patients with an eosinophilic phenotype. The press release noted that, if approved, mepolizumab is expected to become the first once-monthly biologic for COPD.

Innovative Medical Device Approved: Huadong Medicine Achieves Another Global First

February 19,Huadong MedicineWholly-owned subsidiaryHangzhou Zhongmei HuadongReceivedNational Medical Products AdministrationThe "Medical Device Registration Certificate" issued by the NMPA has approved the registration application for the innovative Class III medical device, a percutaneous glomerular filtration rate measurement device, allowing it to be marketed.

The announcement shows that the MediBeacon® Transdermal GFR System (TGFR), which consists of a percutaneous glomerular filtration rate measurement device and Lumitrace® (Remazirazine, Relmapirazin) injection, isHuadong Medicine (China-US)Developed in collaboration with MediBeacon Inc., a U.S. subsidiary in which the company holds shares, it received FDA approval in January 2025 and is the world's first point-of-care product approved for assessing kidney function in patients with normal or impaired renal function.Huadong Medicine (China-U.S.)

Down Payment Nearly 200 Million Yuan! The First Domestically-Produced Improved New Drug Successfully Goes Global

On February 18, Zhuhai Beihai Biotechnology announced a significant strategic partnership with Zydus Lifesciences, granting it the exclusive commercial rights for the new drug BEIZRAY (Docetaxel-BH009) in the U.S. market.

BEIZRAY is the first domestically developed new drug in China to have successfully obtained authorization for overseas use in the United States in recent years, marking a critical step forward in the internationalization strategy of Chinese biopharmaceutical enterprises.

The drug received U.S. FDA approval in October 2024 for the treatment of common solid tumors such as breast cancer, non-small cell lung cancer, and prostate cancer. Due to the absence of traditional solubilizers (such as Tween 80) in BEIZRAY, its safety and tolerability have been significantly improved.

Qiming Venture Partners Announces Departure of Managing Partner Nisa Leung

On February 17, Qiming Venture Partners announced that Nisa Leung, who has long served as Managing Partner, has officially resigned.

Qiming Venture Partners and Helen Liang initiated a "Management Team Succession Plan" in November 2024 to ensure a smooth transition. As part of this plan, after Helen Liang steps down, Qiming's Managing Partner Michael Hu and Partner Kan Chen will jointly lead Qiming’s healthcare investments.

More Than 50 Scientists Jointly Release the World's Largest AI Biological Model Evo 2

On February 19, Nvidia and the Arc Institute jointly announced a significant breakthrough: Evo 2, the world's largest AI biology model. Developed through the collaboration of approximately 50 scientists from the Arc Institute, Nvidia, Stanford University, the University of California, Berkeley, and the University of California, San Francisco, Evo 2 was trained on over 9.3 trillion nucleotides using genomic data from more than 128,000 species, making it one of the largest publicly available AI biological models to date.

Compared with the first-generation Evo model, Evo 2 not only significantly expands in data scale and training parameters but also incorporates more information from humans, plants, and single-cell and multicellular eukaryotic species, further enhancing the model's complexity and applicability.

HBM and Insilico Reach Strategic Cooperation to Jointly Advance AI-Driven Antibody Drug Development

On February 20, Harbour BioMed and Insilico Medicine announced a strategic partnership to leverage their respective technological strengths in antibody discovery and artificial intelligence, accelerating the development of novel therapeutic antibodies.

CXO Leader Pharmaron: Acquires Controlling Stake in an AI Company Specializing in Oncology

Recently, Pharmaron announced that its subsidiary, Pharmaron Clinical Research Services Co., Ltd., has completed the controlling transaction of Zhejiang Haixin Zhicheng Technology Co., Ltd.

Haixin Zhihui is an AI company focused on patient management in the oncology field. Established in 2018, it was founded by Professor Zhu Jun's team from the Department of Computer Science and Engineering at Shanghai Jiao Tong University and has received investments from well-known institutions such as Sequoia China and Legend Capital.

The company's core advantage lies in utilizing its proprietary digital and AI technology platforms to build a patient management system that strictly adheres to international data privacy regulations. Relying on a strategic partnership with the Chinese Society of Clinical Oncology (CSCO), it has established a real-world data (RWD) network covering over 30 provinces in China, serving hundreds of thousands of patients and tens of thousands of doctors.

(The following articles can be read in their original text by clicking on the titles)

CSPC’s ADC, Which Has Just Entered Phase I Clinical Trials, Sold for 9 Billion Yuan

On the morning of February 19, CSPC PHARMACEUTICAL GROUP LIMITED announced that its subsidiary, Jushi Biopharma, had entered into an exclusive licensing agreement with Radiance Biopharma.

Specifically, CSPC's subsidiary, Giantstone Biologics, has granted the latter exclusive rights for the development and commercialization of its self-developed ROR1 ADC drug SYS6005 in the United States, the European Union, and other countries. In return, Giantstone Biologics will receive an upfront payment of $15 million, potential development and regulatory milestone payments of up to $150 million, and potential sales milestone payments of up to $1.075 billion.

Just three days before the announcement of the outbound licensing deal, CSPC had registered a Phase I clinical trial (CTR20250511) for SYS6005 in patients with various advanced malignant tumors on February 16 on the CDE Drug Clinical Trial Registration and Information Disclosure Platform. As an ROR ADC drug with an MMAE payload, the proposed clinical dosing regimen is Q3W.

A 45 Billion Market Battle Begins: Who Will Be the "Semaglutide" of Lipid-Lowering?

On February 18, the latest clinical data for ART002 injection, developed by Rayz Therapeutics for the treatment of heterozygous familial hypercholesterolemia, showed that only one dose is required to reach drug efficacy saturation, safely and effectively reducing low-density lipoprotein cholesterol (LDL-C).

Global Lipid-Lowering Drug Market Exceeds $33 Billion in 2023, Projected to Surpass $45 Billion by 2033. In China, patients with dyslipidemia and cardiovascular/cerebrovascular diseases are becoming younger, with the prevalence rate among those aged 18 and above rising to 40.4%. The lipid-lowering drug market in China exceeded 25 billion yuan in sales in 2023, showing a clear trend of continued growth.

In addition to traditional lipid-lowering drugs such as statins and fibrates, PCSK9 inhibitors have recently seen a cluster of new drugs produced in China entering the market, including those from Innovent, Junshi, Akeso, and Hengrui, starting to directly compete against Amgen, Sanofi, and Novartis, which have the first-mover advantage.

As a highly popular innovative target, LP(a)-targeting lipid-lowering drugs are showing great potential with more than 10 pipeline drugs successively entering clinical stages.

Under the temptation of a billion-dollar market, who will be the first to become the "semaglutide" in the lipid-lowering field: PCSK9 inhibitors, LP(a) targeted drugs, gene editing therapies...?

AI Drugs: Crossing the "Valley of Death"

On February 14, SIGX1094, a targeted drug pipeline for the treatment of diffuse gastric cancer developed by Shenzhen Signet Biotech, received Fast Track designation from the U.S. FDA. This drug is an innovative first-in-class medication developed using an AI technology platform.

In mid-January, Insilico Medicine, a leading AI drug discovery company in China, also completed an outbound licensing deal worth over US$550 million for a preclinical anticancer candidate drug developed with AI assistance.

Data shows that drug discovery and preclinical research time can be shortened by nearly 40% with the help of AI, and the success rate of new drug development pipelines can be increased 3 to 5 times compared to traditional methods.

Due to the advantages of accelerating drug discovery, improving R&D efficiency, reducing the drug discovery cycle, and saving capital costs, AI has become one of the driving forces of innovation in the pharmaceutical industry. It is increasingly favored by pharmaceutical companies and has driven rapid growth in related businesses.

On February 17, XtalPi, the "first AI drug discovery stock" that went public last year, disclosed its 2024 revenue data. Due to business growth and market opportunities, the company expects its total annual revenue from drug discovery solutions and intelligent automation solutions to reach HKD 2.5 billion, meeting the revenue threshold for commercialized companies under Hong Kong Stock Exchange Rule 18C. In the first half of 2024, this figure was only approximately RMB 1.03 billion.

New Global Target for Parkinson's Disease! First Discovered by a Chinese Research Team

On February 21, a research team from Fudan University made the world's first discovery of a new therapeutic target for Parkinson's disease, FAM171A2, and published their findings online in the international academic journal Science.

The novel therapeutic targets and candidate drugs discovered in this study are expected to intervene in Parkinson's disease from its early stages, slowing down disease progression.

The research team first discovered from the genome-wide association analysis of a large-scale population that FAM171A2 is a Parkinson's disease risk gene. However, as a neuronal cell membrane protein, its function has never been studied before.

It was later confirmed through a series of studies that the neuronal membrane receptor FAM171A2 protein is crucial in promoting the transmission of pathological α-synuclein, and for the first time globally, the binding mechanism between the FAM171A2 protein and α-synuclein was revealed.

The Landscape of the Billion-Dollar Kidney Disease Anemia Market Is About to Change

On the evening of February 20, AstraZeneca announced that it would acquire FibroGen China for approximately $160 million and obtain the exclusive rights to roxadustat (Aeroduo) for the treatment of anemia associated with chronic kidney disease in China.

The transaction is expected to be completed in mid-2025. Upon completion of the settlement, AstraZeneca will acquire all rights to roxadustat in China, while FibroGen retains its rights to roxadustat in the United States and markets not authorized to Astellas.

RoxadustatIt is an innovative oral small-molecule drug for the treatment of anemia, and also the world's first HIF-PHI.In 2018, the drugApproved for marketing in China as a Class 1 innovative drug for the treatment of anemia caused by chronic kidney disease, and included in the National Medical Insurance Catalog in 2019.

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