Henlius Biopharmaceutical Editor September 23, 2024 09:21 Shanghai

H drug Hans form ® It is the world's first anti-PD-1 monoclonal antibody approved for first-line treatment of ES-SCLC

H drug Hans form ® Expected to become the first and only anti-PD-1 monoclonal antibody marketed in Europe for first-line treatment of ES-SCLC

H drug Hans form ® Currently approved for market in countries such as China, Indonesia, Cambodia, and Thailand, benefiting approximately 80000 patients

On September 20, 2024, Fosun Pharma (2696. HK) announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the company's independently developed anti-PD-1 monoclonal antibody H drug, Hansid ® (Sullimumab) has received positive approval for marketing authorization, and it is recommended to approve its indication for first-line treatment of extensive stage small cell lung cancer (ES-SCLC). In 2023, Fosun Pharma partnered with Intas to grant exclusive development and commercialization rights for its H drug in over 50 countries in Europe and India. The positive opinion from CHMP this time marks a step closer to achieving wider accessibility of H drugs in Europe.

Picture : Executive Director and CEO of Fosun Pharma: Dr. Zhu Jun

The positive feedback from CHMP marks significant progress in the efforts of Fosun Pharma to accelerate the global expansion of its products, further validating the company's patient-centered research and development philosophy and firm determination to implement internationalization strategies. We look forward to the official approval of this treatment plan in Europe and bringing more treatment options and hope to more patients locally and globally.

Picture: Executive Vice President of Accord Europe Middle East and North Africa Region: Mr. Paul Tredwell

We are very encouraged by the positive feedback provided by CHMP. This not only further consolidates our partnership with Fosun Pharma, but also means that Slulimumab is expected to become an important treatment option for more patients with extensive stage small cell lung cancer. For patients with limited treatment options and poor prognosis, this is undoubtedly a significant breakthrough.

Adhering to integrity and innovation, focusing on the clinical needs of small lungs

Lung cancer is the cancer with the highest incidence rate and mortality rate in the world. According to the latest GLOBOCAN data, there will be more than 2.48 million new lung cancer cases in the world in 2022, accounting for 12.4% of new cancer cases [1]. Small cell lung cancer (SCLC) accounts for 15% -20% of all lung cancers, and is characterized by high malignancy, early metastasis, rapid disease progression, and extremely poor prognosis. SCLC is divided into localized and extensive stages, with approximately 30% -40% of patients diagnosed in the localized stage and the rest in the extensive stage. In the European Union, the proportion of SCLC patients is approximately one to five in ten thousand of the total population, which falls within the scope of the EU's orphan drug qualification recognition. In December 2022, H drug was granted orphan drug status by the European Commission (EC) for the treatment of SCLC, and in March 2023, it was accepted by the EMA for EU marketing authorization (MAA) application for H drug for the treatment of SCLC.

The positive feedback on the EU market launch of H drug this time is mainly based on the ASTRUM-005 study, which is a randomized, double-blind, placebo-controlled international multicenter phase III study aimed at evaluating the efficacy and safety of Slulimumab combined with chemotherapy compared to placebo combined with chemotherapy for first-line treatment of ES-SCLC. The trial opened 128 trial centers in China, EU Poland, Türkiye, Georgia and other countries, and 585 subjects were enrolled, about 31.5% of whom were white. The results of the ASTRUM-005 clinical trial were first presented orally at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of the American Medical Association (JAMA), one of the world's top four medical journals, becoming the first SCLC immunotherapy clinical study to be published in the main JAMA journal. Based on the ASTRUM-005 study, H drug has been approved for first-line treatment of ES-SCLC in China and multiple Southeast Asian countries, becoming the world's first anti-PD-1 monoclonal antibody approved for first-line treatment of small cell lung cancer.

Global layout, innovation driven high-quality overseas expansion

As the first independently developed innovative monoclonal antibody by Fosun Pharma, H drug focuses on high-risk cancer types such as lung cancer and digestive tract tumors. It has been approved in China for the treatment of microsatellite highly unstable (MSI-H) solid tumors, squamous non-small cell lung cancer (sqNSCLC), ES-SCLC, and esophageal squamous cell carcinoma (ESCC). Fosun Pharma has simultaneously conducted more than 10 clinical studies on immune combination therapy with H drug as the core worldwide. In the field of lung cancer, the company has now fully covered the first-line treatment of lung cancer. In addition to approved SQNSCLC and ES-SCLC, the marketing application for H-drug combined with chemotherapy as first-line treatment for non squamous non-small cell lung cancer (nsNSCLC) has been accepted by the National Medical Products Administration (NMPA) of China, and an international multicenter phase III clinical trial of H-drug combined with chemotherapy and concurrent radiotherapy as first-line treatment for limited stage small cell lung cancer (LS-SCLC) has been conducted worldwide. In addition, the company is conducting a head to head bridging trial of H-drug compared to first-line standard treatment atezolizumab for ES-SCLC in the United States to further support the market application of H-drug in the United States.

The globalization pace of H drug is constantly accelerating. As of now, the product has been approved for market in China, Indonesia, Cambodia, Thailand and other countries, with external authorization covering more than 70 countries and regions such as the United States, Europe, Southeast Asia, the Middle East and North Africa. On December 22, 2023, Fosun Pharma obtained the EU GMP certificate for its H drug production line, marking that the company's Xuhui and Songjiang bases have successfully passed the EU GMP inspection for H drug related production areas and comply with EU GMP standards. In the first quarter of 2024, the company efficiently completed the first batch of overseas shipments of H drug, marking H drug as the first domestically produced anti-PD-1 monoclonal antibody to land in Southeast Asian countries, bringing new treatment options to more patients worldwide.

In the future, Fosun Pharma will continue to prioritize patients, focus on unmet clinical needs, innovate and upgrade, and accelerate the delivery of high-quality Chinese drugs to patients worldwide.