Alpha Biopharma Strengthens Position in Hematologic Malignancies with AZ Collaboration and Wugen Cell Therapy Partnership

With the continuous development of the economy and rapid improvement in medical standards, the average life expectancy of residents in China has significantly increased, leading to a rising diagnosis rate of critical illnesses such as cancer, which are highly correlated with age. Data shows thatIn China, the overall cancer incidence rate was 278.07 per 100,000 people in 2014, rising to 315.64 per 100,000 people by 2020.

Among them, hematologic malignancies are highly lethal tumors, commonly including leukemia, myeloma, and lymphoma.In 2020 alone, there were 85,400 new cases of leukemia among patients with hematologic malignancies, indicating a huge market potential for cell immunotherapy within the overall domestic medical demand for hematologic malignancies.

The primary treatment modalities for hematologic malignancies are radiotherapy, chemotherapy, and hematopoietic stem cell transplantation. Each of these approaches has its limitations, particularly for patients with relapsed or refractory hematologic tumors, for whom currently there are no highly effective therapeutic options. However,Novel immune cell therapies have brought new survival opportunities to these patients, while cell therapy also holds promise for application in solid tumors beyond hematologic malignancies.

Regarding cancer treatment, Alpha Biopharma (hereinafter referred to as “Alpha Biopharma”), a company focused on integrating innovative oncology therapies, recently announced a co-development agreement with U.S. cell therapy innovator Wugen Inc. for its next-generation cell therapy. Immunocyte therapy will empower healthcare professionals to adopt more flexible and innovative treatment regimens to address the needs of cancer patients.

Alpha Biopharma, founded in 2017 by Mr. Zhang Yong and other co-founders, is dedicated to the clinical development of innovative drugs worldwide. Mr. Zhang began his career in the pharmaceutical industry after working in a clinical setting at Shanghai Ruijin Hospital in the early 1990s. From 1998 to 2008, he worked at Roche, where he participated in and led the commercialization of numerous top-tier innovative drugs in the fields of oncology and antiviral therapy. During this period, he also earned an EMBA degree from CEIBS (China Europe International Business School).

In addition to founding Alpha Biopharma, Mr. Zhang Yong has invested in biopharmaceutical companies including Chipscreen Biosciences, Mijian Medical, Taifeier Pharmaceuticals, Mojia Biologics, CVI Pharmaceuticals, and TianGuangShi Biologics. He has also served as a board member at Hanyu Medical, Qingyun Technology, and MicroTech Medical. Furthermore, the entire executive team at Alpha Biopharma possesses 15–30 years of management experience in R&D, clinical development, and marketing at multinational pharmaceutical corporations. Most of the executives have been partners for over a decade, and the executive turnover rate is below 10%.

By leveraging a cohesive management team, overseas scientific advisors at the forefront of their fields, and optimized strategies for innovative drug development, Alpha Biopharma adopted a “begin-with-the-end-in-mind” approach from its inception. When selecting R&D targets, the company evaluated the clinical application and commercial potential of drug candidates from the perspectives of physicians and patients, prioritizing research directions with high clinical value to address unmet medical needs.

Under the leadership of the team,Alpha Biopharma focuses on a multi-dimensional layout encompassing R&D, marketing, and intellectual property protection. By engaging in deep collaboration and business development with leading domestic and international CROs, CMOs, hospitals, and research institutions, Alpha Biopharma ensures the orderly implementation of its projects.

In its founding year, Alpha Biopharma signed a cooperation agreement with AstraZeneca (AZ).Through this collaboration, Alpha Biopharma strategically enters the lung cancer brain metastasis market with its lead candidate drug Zorifertinib (AZD3759). Leveraging a highly integrated clinical and project management team, the company is driving the efficient completion of international multicenter Phase II and III clinical trials. Upon approval, this product is expected to pioneer a new paradigm in the global treatment landscape for lung cancer brain metastases.

Lung cancer is one of the malignant tumors with the fastest growing incidence and mortality rates, posing the greatest threat to public health and life. Over the past 50 years, many countries have reported a significant increase in both the incidence and mortality rates of lung cancer. Among males, lung cancer ranks first in both incidence and mortality among all malignant tumors; among females, it ranks second in incidence and second in mortality. The vast market potential for lung cancer treatments is the key factor driving Alpha Biopharma’s decision to enter the field of lung cancer therapeutics.

Alpha Biopharma’s Zorifertinib is a next-generation EGFR-targeted inhibitor specifically designed for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and central nervous system (CNS) metastases. With a blood-brain barrier penetration rate of up to 100%, it is a Class 1 new drug supported by the National Major New Drug Creation Special Fund. Leveraging Zorifertinib, Alpha Biopharma has rapidly entered the commercialization phase, established self-sustaining revenue capabilities, and reduced entrepreneurial risks. The company’s team enriches its product pipeline through a collaborative innovation model, ensuring sustainable corporate development.

Furthermore, Alpha Biopharma recently entered into a collaboration agreement with Wugen Inc. The two parties will jointly develop and manufacture universal cell therapy products in mainland China, the Hong Kong Special Administrative Region, the Taiwan Region, the Macao Special Administrative Region, and Singapore, while accelerating international commercialization efforts to address current challenges in the treatment of hematologic malignancies.

Universal off-the-shelf memory NK cell therapy developed by Wugen Inc. provides a safe, universal treatment with no significant side effects, bringing about a revolutionary change in the treatment of hematologic malignancies.Overseas human clinical data demonstrate that, in the absence of effective treatments for hematologic malignancies, off-the-shelf memory NK cell therapy can significantly prolong survival in patients with refractory or relapsed acute myeloid leukemia, exhibiting favorable therapeutic efficacy.

Moreover, Wugen Inc.’s novel technological approach demonstrates efficacy across a variety of hematologic malignancies and may be approved for treating patients who are otherwise intolerant to T-cell therapies. This implies that the therapy will address the needs of patients with diverse tumor types, holding significant potential for large-scale clinical application.

In terms of financing, Alpha Biopharma completed a Series A funding round worth tens of millions of US dollars in June 2018. This round was led by Qiming Venture Partners, with participation from Taifu Capital and Lize Capital. Regarding Alpha Biopharma's latest round of financing, the crossover round is also set to conclude soon. The funds raised will be used for clinical development, the creation of subsequent new product lines, and talent acquisition.

In recent years, driven by national policies such as healthcare reform that encourage the research and development (R&D) of innovative drugs, and coupled with the vast pharmaceutical market demand both domestically and globally, the R&D and innovation of anti-tumor drugs in China are witnessing a flourishing landscape. Innovative drugs and technologies have become hotspots for industrial capital, with a significant influx of pharmaceutical talent and resources gradually shifting to China.

Supported by a comprehensive combination of policy, capital, and talent, innovative pharmaceutical companies are poised to encounter unprecedented development opportunities. In the future, Alpha Biopharma will remain committed to the research and development of innovative drugs, striving to become a globally influential provider of innovative therapeutics under the encouragement of national policies and the leadership of its management team.

References:

1. Chen et al. 2014 annual report of cancer in China, Chinese Journal of Cancer Research

2. Globocan 2020, International Agency for Research on Cancer, WHO