CStone Pharmaceuticals Expands Global Reach with Strategic Licensing Deal for Sugemalimab in Middle East, North Africa, and South Africa

CStone Pharmaceuticals (2616.HK) Announces Strategic Commercial Partnership with UAE-Based PharmaLink Store- L.L.C - O.P.CIt was recently announced that CStone Pharmaceuticals (2616.HK) has entered into a strategic commercial partnership with Pharmalink Store- L.L.C - O.P.C (“Pharmalink”), a well-known pharmaceutical company headquartered in the United Arab Emirates. Under the licensing and commercialization agreement, Pharmalink will obtain the commercialization rights for CStone Pharmaceuticals’ sugemalimab in the Middle East and North Africa region, including Saudi Arabia, the United Arab Emirates, Kuwait, Qatar, Oman, Bahrain, Algeria, Tunisia, Egypt, Morocco, Libya, as well as South Africa.

 

CStone Pharmaceuticals will receive an upfront payment and subsequent regulatory milestone payments from PharmaLink, as well as royalties on the net sales of sugemalimab, while PharmaLink will be responsible for the registration and commercialization activities of sugemalimab in the aforementioned regions. CStone Pharmaceuticals will be responsible for the product supply of sugemalimab.

 

It is reported that this collaboration marks the second major international partnership CStone Pharmaceuticals has secured for the global commercialization of sugemalimab. Following the strategic cooperation with Ewopharma in Central and Eastern Europe and Switzerland in the first half of 2024, this latest agreement further expands the global footprint of sugemalimab into the Middle East and Africa.

The Lifeline of Healthcare in the GCC Region

PharmaLink’s official website states that the company’s mission is to deliver first-class healthcare services in the GCC region and address unmet clinical needs. Its development goals include further consolidating its position as the leading healthcare provider in the region by 2030.

 

GCC is the acronym for the Gulf Cooperation Council. The GCC was established on May 25, 1981, in Abu Dhabi, United Arab Emirates. Its member states include Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, the Sultanate of Oman, the Kingdom of Bahrain, and the Republic of Yemen. The General Secretariat is located in Riyadh, the capital of Saudi Arabia. The supreme authority is the Supreme Council, composed of the heads of the member states, with the chairmanship rotating annually among them. These seven countries share similar political and economic systems, maintain close royal ties, and have common interests in political, economic, and defense matters, making the GCC a significant political and economic organization in the Middle East.

 

It is worth noting that foreign trade plays a crucial role in the national economies of the seven GCC countries. Due to their undiversified economic structures, these nations rely heavily on imports for most of their daily necessities and production inputs, apart from oil and petrochemical products.

 

In the healthcare sector, particularly in pharmaceuticals, the government has always played a central role, with the Ministry of Health responsible for regulating the pharmaceutical industry and drug pricing. There are also significant restrictions on the localization of medical resources; imports of drugs that can be produced domestically are subject to quotas, and the government provides subsidies of 10%–15% to the local pharmaceutical industry during centralized volume-based procurement bidding.

 

Meanwhile, in terms of pharmaceutical regulation, the majority of administrators overseeing healthcare regulatory systems in Middle Eastern and North African countries have received education in Europe or the United States. These countries enforce more stringent regulatory requirements. For instance, nations such as Turkey, the United Arab Emirates, and Egypt have adopted frameworks similar to that of the U.S. Food and Drug Administration (FDA), aligning their regulatory standards with international norms. This implies that pharmaceutical companies must ensure their products meet all necessary criteria throughout research and development, regulatory registration, and clinical trials, including compliance with International Council for Harmonisation (ICH) guidelines and World Health Organization (WHO) Prequalification (PQ) certification.

 

However, the situation varies across individual GCC countries. Significant disparities in per capita GDP among these nations lead to markedly different market preferences for pharmaceutical consumption. Taking Saudi Arabia as an example, although it also faces substantial reliance on imports due to insufficient domestic drug production capacity, the high per capita GDP driven by abundant oil resources has resulted in elevated consumption levels and stronger purchasing power across the region, thereby generating considerable demand for originator and patented drugs. In contrast, in North African countries represented by Egypt, 90% of pharmaceuticals are domestically produced generics. Moreover, due to the lack of a comprehensive chemical industry system and supply chain, Egypt’s pharmaceutical sector is heavily dependent on imports of active pharmaceutical ingredients (APIs).

 

This underscores the significance of PharmaLink. Established in 1993, PharmaLink is an industry-leading company headquartered in the United Arab Emirates, with Dr. AbdulRauf Jabour, its co-founder, serving as Chief Executive Officer. The company is dedicated to promoting innovative and specialized life-saving pharmaceutical and biotechnology products across the Middle East and Africa.

 

PharmaLink has established a highly integrated framework encompassing drug registration, importation, marketing, distribution, and retail. In addition to its robust marketing and distribution platforms, the company operates chain pharmacies under the “Medicina” and “Al Manara” brands, including hospital pharmacies strategically located in key regions. Leveraging years of accumulated resources and expertise, PharmaLink provides comprehensive coverage of both private and institutional markets, ensuring that patients across the Middle East and Africa have access to the latest therapies. For companies seeking to expand their product pipelines into GCC countries, PharmaLink serves as a vital bridge.

 

For companies like CStone Pharmaceuticals expanding into the GGC markets, partnering with PharmaLink allows them to focus more on the core strengths of their products, namely ensuring that their innovative drug R&D is conducted in accordance with international standards.

 

Notably, this marks PharmaLink’s first licensing agreement with a Chinese company. As of now, PharmaLink’s official website does not list any partners from China. It can be said that CStone Pharmaceuticals has seized the first-mover advantage in this instance.

Join Hands with Marketing Leaders for Continuous Expansion

The focus of this transaction is Sugemalimab Injection, an anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals, marketed under the brand name Cejemmy.^®。

 

The development of sugemalimab is based on OmniRat, licensed from Ligand Pharmaceuticals in the United States.^®Transgenic Animal Platform. This platform enables the one-stop generation of fully human antibodies. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab is a G-type immunoglobulin 4 (IgG4) monoclonal antibody drug that most closely resembles natural human IgG4, thereby reducing the potential risk of immunogenicity and related toxicity in patients. Compared with similar drugs, sugemalimab offers unique advantages. Its unique molecular design confers a dual mechanism of action: it not only blocks the PD-1/PD-L1 interaction but also mediates the engagement between PD-L1-positive tumor cells and tumor-associated macrophages (TAMs), inducing antibody-dependent cellular phagocytosis (ADCP) without impairing effector T cells. This differentiated design has enabled sugemalimab to demonstrate potential best-in-class efficacy and safety across various types of tumors.

 

Currently, the NMPA has approved five indications for sugemalimab: first-line treatment in combination with chemotherapy for patients with metastatic squamous and non-squamous NSCLC; treatment of patients with unresectable stage III NSCLC who have not experienced disease progression following concurrent or sequential chemoradiotherapy; treatment of patients with relapsed or refractory extranodal NK/T-cell lymphoma; first-line treatment in combination with fluoropyrimidine- and platinum-based chemotherapy for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma; and first-line treatment in combination with fluoropyrimidine- and platinum-based chemotherapy for patients with unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma expressing PD-L1 (Combined Positive Score [CPS] ≥ 5).

 

The European Commission (EC) has approved sugemalimab (brand name: Cejemly^®) in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic NSCLC without EGFR sensitizing mutations, or without ALK, ROS1, or RET genomic tumor alterations.

 

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved sugemalimab in combination with platinum-based chemotherapy for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) who do not have EGFR sensitizing mutations or ALK, ROS1, or RET genomic tumor alterations.

 

Dr. Yang Jianxin, CEO, President of R&D, and Executive Director of CStone Pharmaceuticals, stated that sugemalimab is the first PD-L1 monoclonal antibody developed by a Chinese biopharmaceutical company to successfully enter the EU—the world’s second-largest pharmaceutical market—and the UK. Long-term survival data recently presented at the 2024 European Society for Medical Oncology (ESMO) Annual Congress further confirmed the value of sugemalimab in the first-line treatment of metastatic non-small cell lung cancer.

 

CStone Pharmaceuticals expects to finalize additional commercial partnerships in the near term across Western Europe, Latin America, Southeast Asia, and Canada. Meanwhile, the Company is actively engaging with regulatory authorities regarding the registration and market approval of sugemalimab for additional indications, including Stage III non-small cell lung cancer, first-line gastric cancer, and first-line esophageal squamous cell carcinoma, with the aim of providing a broader range of innovative treatment options for patients worldwide.

Chinese Pharmaceutical Companies Break Through: Heading to MENA

In recent years, as Chinese innovative pharmaceutical companies have been expanding into international markets, the Middle East and North Africa (MENA) region has emerged as a popular destination, with an increasing number of pharmaceutical firms actively establishing their presence there. MENA refers to the Middle East and North Africa, covering a vast geographical area that stretches from Morocco to Iran and includes all countries in the Middle East, the Mashriq, and the Maghreb.

 

In December 2022, Junshi Biosciences and Hikma Pharmaceuticals entered into a licensing and commercialization agreement to jointly develop and commercialize the PD-1 monoclonal antibody toripalimab in 20 countries across the Middle East and North Africa (MENA) region, including Saudi Arabia, the United Arab Emirates, Qatar, Jordan, Morocco, and Egypt. It is reported that toripalimab has already received formal approval in Jordan.

 

In December 2023, CanSino Biologics announced a major partnership at the China-Saudi Arabia Investment Conference. The biotechnology company, known for its innovative vaccines as flagship products, signed a framework agreement on vaccine collaboration with SPIMACO, a leading pharmaceutical manufacturer in Saudi Arabia. This historic cooperation marks CanSino Biologics’ formal entry into the Saudi pharmaceutical market and will jointly promote the development of innovative vaccines in the Middle East and North Africa region.

 

Northeast Pharmaceutical, a renowned pharmaceutical production and export base in China, recently announced the signing of an investment framework agreement with Muscat Changming Investment Co., Ltd. to jointly establish a pharmaceutical enterprise in the Sultanate of Oman. This move marks Northeast Pharmaceutical’s formal entry into the Middle East and North Africa pharmaceutical market.

 

Northeast Pharmaceutical Muscat Changming Investment Co., Ltd., renowned for its integrated “API + finished dosage form” model, has signed an investment framework agreement to jointly establish a pharmaceutical enterprise in the Sultanate of Oman, marking its expansion into the Middle East through a NewCo structure.

 

In 2024, the global footprint of Chinese biotech companies continued to expand. In June, Hanquyou®, a biosimilar independently developed and manufactured by Henlius (02696.HK), was shipped from China to Saudi Arabia, becoming the first domestically produced monoclonal antibody biologic to enter the Middle Eastern market. Meanwhile, Brukinsa®, the BTK inhibitor and “billion-dollar small-molecule drug” from BeiGene (BGNE.NS, 06160.HK, 688235.SH), has also extended its commercial presence to the Middle East and North Africa region.

 

CStone Pharmaceuticals followed closely behind.

 

Notably, financial report data shows that CStone Pharmaceuticals achieved profitability for the first time in the first half of 2024, with total revenue reaching RMB 254.2 million and net profit nearing RMB 16 million. As of June 30, 2024, its cash reserves amounted to RMB 814 million, making it another Hong Kong-listed company to turn a profit following OneConnect Financial Technology, Ping An Health, and others.

 

Notably, the first half of the year marked a significant turning point in the Company’s development, driven by diversified revenue streams and sustained cost control, while robust cash flow has laid a solid foundation for future growth. In particular, continued momentum in both the mainland China and overseas markets, coupled with the ongoing advancement of innovative products from the Pipeline 2.0 into clinical stages, will enable the Company to expand its global operations and achieve sustainable profitability.