Guangzhou, China/Riyadh, Saudi Arabia – February 3, 2026 – Bio-Thera Solutions (688177:SH; “Bio-Thera”), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and Avalon Pharma (Middle East Industries Company Limited), a leading Saudi-based pharmaceutical manufacturer, announce today they have reached commercialization and license agreements for BAT3306, a Proposed Keytruda® Biosimilar.
Under the agreement, Bio-Thera will maintain responsibility for development, manufacturing, and supply of BAT3306. Avalon Pharma will be responsible for seeking regulatory approvals as well as commercialization in the licensed territories in Saudi Arabia and MENA.
“Bio-Thera is committed to expanding patient access to critical oncology therapies in Saudi Arabia and the wider MENA region,” said Bert Thomas, Senior Vice President of Business Development of Bio-Thera, Bio-Thera Solutions. “Our partnership with Avalon, a trusted regional partner with expertise in the oncology space, will bring one of the most important oncology treatments of the last 50 years to the region. This is the first of many immuno-oncology biosimilars that Bio-Thera is developing for oncology patients in MENA and around the world.”
Mr. Mohamed Maher Al Ghannam, Managing Director & CEO, Avalon Pharma, stated: “This agreement represents a pivotal step in the execution of our oncology and biosimilars strategy. Partnering with Bio-Thera strengthens our ability to deliver complex biologic therapies and reflects our evolution toward a specialty-focused pharmaceutical platform. Together, we aim to improve access to high-quality oncology treatments while supporting sustainable healthcare systems across the region.”
About BAT3306 (pembrolizumab)
BAT3306 is a proposed biosimilar to pembrolizumab, a humanized monoclonal antibody and immune checkpoint inhibitor used in cancer immunotherapy. Pembrolizumab works by blocking the PD-1 (programmed cell death protein 1) receptor on T cells, preventing interaction with its ligands PD-L1 and PD-L2. This inhibition removes a key "brake" on the immune system, allowing T cells to recognize and attack cancer cells more effectively. Pembrolizumab is a cornerstone of modern immunotherapy and is used in both first-line and later-line settings, often in combination with chemotherapy or targeted therapies, depending on cancer type and biomarker status.
About Bio-Thera Solutions:
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI® (adalimumab) and BETAGRIN® (bevifibatide citrate) Injection in China, STARJEMZA® (ustekinumab) in the US and USYMRO®(ustekinumab) in EU, and TOFIDENCE®/BAT1806 (tocilizumab) and AVZIVI® (bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY® in China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, please visit www.bio-thera.com/en/ or follow us on X (@bio_thera_sol) and WeChat (Bio-Thera).
About Avalon Pharma:
Avalon Pharma is a leading regional healthcare company headquartered in Riyadh, Saudi Arabia, committed to advancing human health through innovation, quality, and sustainable growth. With a strong presence across the Middle East, Avalon develops, manufactures, and markets a broad range of prescription medicines, over-the-counter products, and dermo-cosmetic solutions that meet the highest international standards.
Driven by science and guided by purpose, Avalon Pharma combines robust research capabilities with state-of-the-art manufacturing and strategic collaborations to address evolving healthcare needs. Our operations are built on global best practices, GMP-certified facilities, and a deep commitment to operational excellence and regulatory compliance.
Through continuous investment in research, digital transformation, and talent development, Avalon Pharma is shaping the future of healthcare in alignment with Saudi Arabia’s Vision 2030, supporting a healthier society and a knowledge-driven economy.
Our Focus Areas:
• Prescription and OTC pharmaceuticals
• Dermatology and dermo-cosmetic innovation
• Consumer health and wellness solutions
• Digital health and data-enabled healthcare insights
Key Facts:
• Headquarters: Riyadh, Saudi Arabia
• Markets Served: GCC, and Levant
• Portfolio: 150+ registered products
• Certifications: GMP, ISO 9001, ISO 14001
• Founded: 1998
At Avalon Pharma, we are redefining what it means to be a regional pharmaceutical leader — delivering trusted, science-backed healthcare solutions that empower patients, support professionals, and drive sustainable growth.
Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2024. The company assumes no obligation to update any information contained herein.
Bio-Thera Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements relating to BAT3306 or the product pipelines in general of Bio-Thera Solutions. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing "could," "may," "should," "will," "would," "anticipate," "believe," "plan," "promising," "potentially," or similar expressions. They reflect the company's current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions, and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company's financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company's views or otherwise.
Avalon Pharma Cautionary Note Regarding Forward-Looking Statements
This document contains certain forward-looking statements relating to Avalon Pharma and its product pipeline. Readers are cautioned that reliance on forward-looking statements involves known and unknown risks and uncertainties. Forward-looking statements include, but are not limited to, statements containing words such as “could,” “may,” “should,” “will,” “would,” “anticipate,” “believe,” “plan,” “expect,” “potential,” or similar expressions.
These statements reflect Avalon Pharma’s current views with respect to future events and are based on assumptions believed to be reasonable in light of information currently available. Such statements are not guarantees of future performance or outcomes. Actual results and developments may differ materially from those expressed or implied in forward-looking statements due to various factors, including, without limitation, risks and uncertainties inherent in pharmaceutical research and development, pre-clinical and clinical studies, regulatory approval processes, manufacturing, commercialization, competition, intellectual property protection, product efficacy or safety, changes in global healthcare conditions, financial performance, and applicable laws and regulations.
Forward-looking statements are made as of the date of their issuance only. Avalon Pharma undertakes no obligation to update or revise any forward-looking statements, except as required by applicable laws or regulations.
