Update to PR: The exclusive license granted by Helsinn to Fosun Pharmaceutical AG with respect to Akynzeo^® oral in Hong Kong SAR and Macau SAR will be effective upon completion of the transfer of the relevant marketing authorization from the current holder Mundipharma to Fosun Pharma. This process is underway and expected to conclude in June 2022. Until such transfer is complete, the licensed rights for Oral Akynzeo remain exclusively with Mundipharma in Hong Kong SAR and Macau SAR.

Lugano, Switzerland – Shanghai, China,  October 12, 2021 - Helsinn Group (“Helsinn”), a Swiss Biopharmaceutical Group with an innovative R&D pipeline in cancer supportive care and oncology therapeutics, strategically investing in a fully integrated targeted therapy structure to develop, manufacture and commercialize small molecules in precision medicine with higher market potential, and Fosun Pharmaceutical A.G., a corporation organised and existing under the law of Switzerland and a wholly owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma), a leading global pharmaceutical and healthcare provider in China, announced today the signing of exclusive license and distribution agreements effective from October 1st 2021 in the territory of Mainland China for Aloxi^®, Akynzeo^® and anamorelin.

Under the terms of the agreements, Helsinn will grant Fosun Pharmaceutical A.G. an exclusive license to distribute, promote, market, and sell the following products in the aforesaid territory:

Approved products:
• Aloxi^® (Palonosetron hydrochloride) for the prevention of Chemotherapy Induced Nausea and Vomiting (CINV) and for Post-Operative Nausea and Vomiting

• Akynzeo^® oral (Netupitant and Palonosetron hydrochloride) for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and with moderately emetogenic cancer chemotherapy

Products under development:
• NEPA (Fosnetupitant and Palonosetron hydrochloride) IV, which is being developed in China for the prevention of CINV 

• anamorelin, a selective, novel, orally active ghrelin receptor agonist, which is being developed for the treatment of Malignancy Associated Weight Loss and Anorexia in non-small cell lung cancer patients 

Helsinn will also grant Fosun Pharmaceutical A.G. an exclusive license for the said products in Hong Kong SAR and Macau SAR. In addition, Helsinn’s Chinese subsidiary, Helsinn Pharmaceuticals Beijing Co. Ltd. (HPC) will provide Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., a subsidiary company of Fosun Pharma with certain medical, marketing and commercial services, including co-promotion services in Shanghai, China, in support to the commercialization of the products in Mainland China, Hong Kong SAR and Macau SAR.  

Riccardo Braglia, Helsinn Group Vice Chairman and CEO, commented: “Delivering therapies and supportive care to those living with cancer is at the core of what we do here at Helsinn, and we are pleased to have found a partner in Fosun Pharmaceutical A.G. that shares our values. Through these agreements we are able to provide patients across Mainland China and other territories with much needed therapies, targeting a variety of cancer-related illnesses and we look forward to working closely with Fosun Pharma in doing so.”

Wu Yifang, Chairman and CEO of Fosun Pharma commented: “We are very pleased to sign this agreement with Helsinn. At Fosun, we are passionate about providing better health solutions for patients and these exclusive license and distribution agreements for Aloxi^®, Akynzeo^® and anamorelin across Mainland China, Hong Kong SAR and Macau SAR show our commitment to that mission. We are looking forward to working with Helsinn and to making these therapies available to patients in these territories as soon as possible.” 

About Aloxi^® in China

Palonosetron hydrochloride injection (strength: 5 ml/ 0.25 mg as Palonosetron) is indicated in adults for prevention of acute nausea and vomiting associated with Highly emetogenic cancer chemotherapy and Moderately emetogenic cancer chemotherapy. This product is indicated in pediatric patients aged 1 month to less than 17 years for: Prevention of acute nausea and vomiting associated with emetogenic cancer chemotherapy, including highly emetogenic cancer chemotherapy.

Palonosetron Hydrochloride Soft Capsules (0.5 mg as Palonosetron) is indicated for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

Palonosetron hydrochloride injection (strength: 1.5 ml/0.075 mg as Palonosetron) is indicated in adults for prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery.

About Akynzeo^® oral in China

Netupitant and palonosetron hydrochloride capsules is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and with moderately emetogenic cancer chemotherapy.

NEPA (Fosnetupitant and Palonosetron hydrochloride) IV 

The product containing 235 mg of fosnetupitant (equivalent to 260 mg fosnetupitant chloride hydrochloride) and 0.25 mg of palonosetron (equivalent to 0.28 mg of palonosetron hydrochloride) is being developed in China for prevention of acute and delayed nausea and vomiting associated with emetogenic cancer chemotherapy. 

About anamorelin
Anamorelin is a selective, novel, orally active ghrelin receptor agonist. Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite and metabolism. Anamorelin is an investigational agent, which is being developed for the treatment of Malignancy Associated Weight Loss and Anorexia in non-small cell lung cancer patients. Anamorelin is not approved by the China National Medical Products Administration (“NMPA”).  

About the Helsinn Group

Helsinn is a Swiss Biopharmaceutical Group with an innovative R&D pipeline in cancer supportive care and oncology therapeutics, strategically investing in a fully integrated targeted therapy structure to develop, manufacture and commercialize small molecules in precision medicine with higher market potential, thanks to a consolidated track record, a solid revenue stream in B2B and strong cash flow and cash position.

Helsinn is building market differentiation in B2C in the U.S. and China and is owned by a third-generation healthcare entrepreneurial family.

Since 1976, Helsinn has been improving the lives of patients, guided by core family values of respect, integrity and quality and through a unique integrated licensing business model, and by collaborating with success in about 190 countries with long-standing partners, who share our values.

The Group’s pharmaceutical business (Helsinn Healthcare S.A.) is headquartered in Lugano, Switzerland with operating subsidiaries in the U.S. (Helsinn Therapeutics (U.S.), Inc.) and China (Helsinn Pharmaceuticals (Beijing) Co., Ltd) which market the Group’s products directly in these countries. The Group has additional operating subsidiaries in Switzerland (Helsinn Advanced Synthesis S.A., an active pharmaceutical ingredient manufacturer) and Ireland (Helsinn Birex Pharmaceuticals Ltd, a drug product manufacturer).

Helsinn Group plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do which is reinforced in the company’s strategic plan by a commitment to sustainable growth.
To learn more about Helsinn Group please visit www.helsinn.com

About Fosun Pharma

Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) is a leading global pharmaceutical and healthcare provider in China. Fosun Pharma strategically operates businesses in the pharmaceutical and health industry, including pharmaceutical manufacturing, medical devices and medical diagnosis, and healthcare services. Through its associated company Sinopharm Co., Ltd., Fosun Pharma’s business extends to pharmaceutical distribution and retail.

Fosun Pharma takes pharmaceutical manufacturing as its core business and sticks to innovative research and development. Through in-house R&D, co-development, in-licensing and incubation, Fosun Pharma had established platforms for small molecule innovative drugs, antibody drugs and cell therapy, focusing on major therapeutic areas, including oncology, immunology, “4 hypers” (hypertension, hyperlipidemia, hyperglycemia and hyperuricemia) and their complications, as well as central nervous system. In the meantime, Fosun Pharma keeps close track of cutting-edge technologies, such as targeted protein degradation, RNA, oncolytic virus and gene therapy to enhance its innovation ability.

Looking forward, under guidance of 4IN strategy (Innovation, Internationalization, Integration and Intelligentization), Fosun Pharma practices innovation and transformation, integrated operation and steady development, as well as the concept of sustainable development. Fosun Pharma is committed to becoming the first-class enterprise in the global mainstream healthcare industry. 
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