Editor of WuXi AppTec Content Team
On November 21st, Cornerstone Pharmaceuticals announced a commercial strategic partnership with Pharmalank Store. Pharmalank is a well-known pharmaceutical company headquartered in the United Arab Emirates. According to the licensing and commercialization agreement, Pharmalank will acquire the commercialization rights of Shuglimab in the Middle East and North Africa region, including Saudi Arabia, United Arab Emirates, Kuwait, Qatar, Oman, Bahrain, Algeria, Tunisia, Egypt, Morocco, Libya, and South Africa.

According to the agreement, Cornerstone Pharmaceuticals will receive the down payment and subsequent registration milestone payments from Pharmarlink, as well as royalties for the net sales of Shuglimab, while Pharmarlink will be responsible for Shuglimab registration and commercialization related activities in the aforementioned regions. Cornerstone Pharmaceuticals will be responsible for the supply of Shuglimab products.

According to a press release from Cornerstone Pharmaceuticals, following the strategic partnership reached with Ewopharma in Central/Eastern Europe and Switzerland in the first half of 2024, this collaboration further expands the global presence of Shugelimab in the Middle East and Africa. Cornerstone Pharmaceuticals is expected to achieve more commercial cooperation in Western Europe, Latin America, Southeast Asia, and Canada in the near future.

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Dr. Yang Jianxin, CEO, R&D President, and Executive Director of Cornerstone Pharmaceuticals, stated that Pharmarlink is a high-quality pharmaceutical marketing partner with strong registration and commercialization capabilities in the Middle East and Africa regions. This collaboration will further assist in maximizing the clinical and commercial value of Shuglimab in the Middle East and Africa, and will also benefit more patients from this innovative drug. The long-term survival data recently released at the 2024 Annual Meeting of the European Society of Internal Oncology (ESMO) further confirms the value of sunitinib in the frontline treatment of metastatic non-small cell lung cancer. At present, Cornerstone Pharmaceutical is actively negotiating with international partners from Western Europe, Latin America, Southeast Asia, and Canada, and it is expected to reach multiple commercial cooperation agreements in the near future. At the same time, Cornerstone Pharmaceutical is actively promoting discussions with regulatory agencies on the registration and listing of other indications for Shuglimab, including stage III non-small cell lung cancer, first-line gastric cancer, and first-line esophageal squamous cell carcinoma, in order to provide more innovative treatment options for patients worldwide.

Dr. Pharmalank CEO Abdul Rauf Eljbour stated, "We are pleased to establish a strategic partnership with Cornerstone Pharmaceuticals for the commercialization of shuglimab in the Middle East and Africa region. Pharmarlink is committed to improving access to life-saving innovations and advanced therapies in various treatment areas for patients in the Middle East and Africa region. Currently, our accumulation of resources, experience, and knowledge is sufficient to ensure the successful promotion of Shuglimab in the region. We also look forward to further expanding our cooperation with Cornerstone Pharmaceuticals

Shuglimab is an anti-PD-L1 monoclonal antibody developed by Cornerstone Pharmaceuticals. At present, the National Medical Products Administration (NMPA) of China has approved Shuglimab (trade name: Zosteryl) ®） Five indications: first-line combination chemotherapy for metastatic squamous and non squamous NSCLC patients; Patients with unresectable stage III NSCLC who have not experienced disease progression after synchronous or sequential radiotherapy and chemotherapy treatment; Treat patients with recurrent or refractory extranodal NK/T-cell lymphoma; Combination therapy of fluorouracil and platinum chemotherapy drugs for first-line treatment of unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma patients; Combination chemotherapy with fluorouracil and platinum based drugs is used as first-line treatment for non resectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma expressing PD-L1 (composite positive score [CPS] ≥ 5).

In addition, the European Commission (EC) has approved the use of Cejemly monoclonal antibody (trade name: Cejemly) ®） Combination platinum chemotherapy is used as first-line treatment for metastatic NSCLC patients without EGFR sensitive mutations or ALK, ROS1, RET genomic tumor variants. The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK has approved the use of combination therapy with platinum based chemotherapy for first-line treatment of metastatic NSCLC patients without EGFR sensitive mutations or ALK, ROS1, RET genomic tumor variants.