On September 28, SBP Group (01177.HK) announced that its core subsidiary, Chia Tai Tianqing Pharmaceutical Group (CTTQ), has entered into a strategic biosimilars partnership with STADA Arzneimittel AG (STADA), a leading European healthcare and pharmaceuticals company. The collaboration will initially focus on TQB3570, a proposed biosimilar to pembrolizumab, and establish a framework that may be expanded to additional biosimilar molecules across oncology and immunology. By combining CTTQ’s capabilities in research and development, manufacturing and quality management with STADA’s international commercial infrastructure and market expertise, the partnership aims to bring high-quality biosimilars to key markets across Europe and Eurasia and broaden patient access.

Subject to the terms and conditions of the Agreement, CTTQ will receive an upfront payment and will be eligible for potential development, regulatory and sales milestone payments of up to €53 million, as well as double-digit profit share for the pembrolizumab biosimilar candidate in the Licensed Territory.

CTTQ shall grant STADA an exclusive license to commercialize the pembrolizumab biosimilar (development code: TQB3570, anti-PD-1 monoclonal antibody) in the European Union, Switzerland, the United Kingdom and the Commonwealth of Independent States (the “Licensed Territory”). The Partnership also includes options to add up to three additional biosimilar molecules across oncology and immunology indications. CTTQ will lead the development, manufacturing and commercial supply of the biosimilar candidates in the Licensed Territory. STADA will hold the marketing authorizations and have exclusive sales and marketing rights in the Licensed Territory, and will also have options for the United States of America and the member states of the Gulf Cooperation Council (GCC).

Pembrolizumab is a humanized anti-PD-1 monoclonal antibody approved for the treatment of dozens of cancers, including lung cancer, gastric cancer, liver cancer and endometrial cancer, and is one of the most widely used oncology medicines globally. The reference product, KEYTRUDA^® and KEYTRUDA QLEX^®, generated approximately US$31.7 billion in global sales in 2025, making it the world’s best-selling oncology medicine. As relevant intellectual-property protections expire, high-quality biosimilars are expected to reduce drug costs, expand patient access and support the sustainability of healthcare systems globally.

“SBP Group’s recent out-licensing agreements reflect growing recognition of our innovation capabilities. Our collaboration with STADA builds on this momentum, bringing our expertise in biologics development, manufacturing and quality to a broader international stage,” said Eric Tse, CEO of SBP Group. “With its long-established commercial infrastructure, deep market understanding and strong presence in Europe, Eurasia and the Middle East, STADA is the ideal partner to help realize the potential of our oncology and immunology biosimilar candidates. Together, we are advancing our globalization strategy and laying the foundation for wider patient access to high-quality biologic medicines.”

STADA CEO Peter Goldschmidt commented: “Partnering with SBP Group and CTTQ on pembrolizumab and further molecules accelerates STADA’s growth in biosimilars. Over almost two decades, we have built a robust franchise with 11 approved biosimilars across diverse therapeutic areas through a partner-of-choice strategy, and this agreement further accelerates that trajectory. The strong international partnerships and numerous launches that SBP Group and CTTQ have already achieved across multiple therapeutic classes will support our joint drive to broaden patient access through competition, not least to the world’s best-selling biologic.”

CTTQ’s TQB3570 pembrolizumab biosimilar candidate is currently in development, with a strategy to secure marketing authorizations ahead of biosimilar market formation in key territories. The company already has eight biosimilars approved in China, with several more in development, and is building on the group’s strong track record of out-licensing and regional collaborations for innovative drugs to globalize its biosimilars portfolio through proven partners such as STADA. In doing so, it is leveraging its innovation capabilities and large-scale manufacturing advantages, with a current biologics manufacturing capacity of 126,000 liters^[1].

STADA’s Chief Commercial Officer, Bryan Kim stated: “Our thorough global market and partner evaluation has identified CTTQ as an ideal long-term partner. Its impressive research and development capabilities are fully integrated with a dedicated manufacturing network that boasts a strong regulatory compliance record and substantial commercial-scale biologics manufacturing capacity. Coupled with STADA’s commercial reach and tender, market‑access and medical capabilities, as well as our near 20 years of biosimilars experience and our leading position in Europe across a broad array of molecules, this partnership positions us strongly to compete in future biosimilar markets.”

The period from 2025 to 2034 is expected to see a wave of patent expirations for biologic medicines globally. Data show that 118 biologic medicines are expected to lose patent protection in the United States during this period, representing an overall originator market worth more than US$230 billion. This points to significant opportunities for the development of biosimilars. SBP Group will continue to leverage its strengths in R&D, manufacturing and quality systems, further strengthen its biosimilars pipeline, and bring more high-quality biologic medicines to international markets, further expanding the breadth and depth of its global business.

About STADA

STADA is headquartered in Bad Vilbel, Germany. The group focuses on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma. Worldwide, STADA sells its products in over 100 countries. In financial year 2025, STADA achieved group sales of € 4,296 million and adjusted constant-currency earnings before interest, taxes, depreciation and amortization (adj. cc EBITDA) of € 961 million. As of 31 December 2025, STADA employed 11,670 people worldwide.

About CTTQ/SBP Group

Chia Tai Tianqing Pharmaceutical Group ("CTTQ") is a core subsidiary of Sino Biopharmaceutical Limited (SBP Group, HKEX: 1177), focused on the research and development, manufacturing and commercialization of innovative and high-quality medicines. Headquartered in China, CTTQ has grown into an innovative pharmaceutical group renowned in oncology, hepatology and respiratory therapeutics, dedicated to continuously providing patients with safe, effective and affordable treatment options.

Notes:

[1] Of which 40,000L is under construction.