May 9, 2023 – Evive Biotech (Evive), a subsidiary of Yifan Pharma announced that the National Medical Products Administration (NMPA) of China has approved the New Drug Application (NDA) of Ryzneuta™ (Efbemalenograstim alfa Injection) for the prevention and treatment of Chemotherapy-Induced Neutropenia (CIN).

 

Neutropenia is a common side effect of cancer chemotherapy and is characterized by persistently low levels of neutrophils (a type of white blood cell with infection-fighting functions) due to the use of chemotherapy drugs, which increases the risk of adverse reactions such as infection and fever in cancer patients during chemotherapy. Ryzneuta™ is a novel long-acting granulocyte colony-stimulating factor (G-CSF), which can stimulate the proliferation, differentiation, and release of neutrophil precursors. It helps to enhance the immune function of cancer patients, prevents the side effects of neutropenia caused by chemotherapy, and avoids the problem of reducing or delaying the administration of chemotherapy drugs, thereby affecting the effect of tumor treatment.

 

According to the package insert of Ryzneuta™ approved by China’s NMPA and the results of three pivotal Phase III studies completed globally, the efficacy and safety of Ryzneuta™ (Efbemalenograstim alfa Injection) are similar to short-acting G-CSF Neupogen^® (Filgrastim) and the long-acting G-CSF Neulasta^® (Pefilgrastim), both are commonly used in the clinical treatment. The trial results prove the efficacy and safety of Ryzneuta™ and verify its advantages in some areas. In a pivotal phase III clinical trial (trial 1) completed in China, patients treated with Ryzneuta™ had higher neutrophil counts than the original filgrastim control group in 4 cycles of chemotherapy, and the difference between groups was statistically significant. Furthermore, the incidence of grade 4 neutropenia and grade 3 and 4 neutropenia in the third chemotherapy cycle was lower than that of the original filgrastim control group, and the difference between the groups was statistically significant. In the two pivotal Phase III clinical trials (trial 2 and trial 3) completed in the United States and Europe, where Ryzneuta™ was administered on the day 2 of each chemotherapy cycle (24 hours after the end of chemotherapy), the clinical efficacy and safety profiles of Ryzneuta™ were similar to the long-acting G-CSF Neulasta^® (Pefilgrastim). Ryzneuta™ could be administered within a shorter time after the end of chemotherapy, thereby improving patient compliance and reducing patient hospitalization and treatment costs.

 

According to IQVIA statistics, the global market share of G-CSF in 2022 was 6.02 billion USD, mainly taken by on Amgen's Neulasta^®. In addition to Amgen's Neulasta^®, there are a number of biosimilars in the United States, including Fulphila^®, Udenyca^®, Ziextenzo^®, Nyvepria^®, Fylnetra^® and others. According to MINEI statistics, China's G-CSF market in 2021 was about 9.72 billion RMB, and about 4.76 billion RMB in 2022 H1, of which the long-acting G-CSFs accounted for about 70% of the market share.

 

An exclusive license agreement for the commercialization of novel biologic drug Ryzneuta™ (efbemalenograstim alfa, long-acting G-CSF) for the treatment of chemotherapy-induced-neutropenia (CIN) in China was signed by Evive Biotech and Chia Tai Tianqing, the core subsidiary of Sino Biopharm, in China; Evive Biotech to receive total upfront and potential milestone payments of up to 242M RMB (est. $35M USD) as well as double-digit royalties on product sales. Evive also signed exclusive license agreements for the commercialization of Ryzneuta with APOGEPHA for German and Swiss markets, with ACROTECH for the US market, as well as with KALTEQ for Greek and Cyprus market.

 

Yifan Pharma has always adhered to the spirit of craftsmanship, the idea of ‘classical findings, classical innovation and scientific verification’, and developed products with clinical value. Our strategic partnership with Sino Biopharm and its subsidiary has successfully promoted Ryzneuta™ to the Chinese market. Following the NMPA approval, we are approaching the final review by FDA and EMA, patients, and families from more than 100 countries will benefit from this novel therapy.

 

Ryzneuta™ is the first self - developed innovative biologics by Evive Biotech, and this approval proves that the team of Evive has the capability to independently carry out the global development of innovative biologics, including preclinical research, regulatory affairs, clinical operation, cGMP manufacturing and quality management, as well as commercialization. We look forward to working with CTTQ to bring this novel treatment to many patients in urgent need in China.

 

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About Yifan Pharma and its Subsidiary Evive Biotech

Yifan Pharmaceutical is an innovative R&D and production company focusing on the pharmaceutical and health sectors. Our vision is to develop innovative drugs with definite clinical values, to help disease-afflicted patients regain health. Currently, we are focusing on four business areas, i.e., biologics, small molecules, synthetic biologics, and special traditional Chinese medicines (TCMs), expanding our product R&D pipelines and innovating drugs for disease treatment to address unmet medical needs.

 

Evive Biotech, a subsidiary of Yifan Pharma, is a global biopharmaceutical company devoted to developing a portfolio of novel biological therapies for patients worldwide. We leverage our proprietary technology platforms to advance a series of innovative drug candidates for oncology, inflammatory and metabolic diseases. Founded in 2004, we currently have operations in the US, Singapore, and China. As the first biopharmaceutical company to build a platform bringing innovative therapies from China to the world, Evive adopts a holistic approach to drug development, combining exceptional research and commercialization capabilities with our world-class in-house manufacture and regulatory expertise as well as extensive international management experience. Through partnerships with industry, physicians, and regulatory authorities, we strive to bring revolutionary remedies to the global markets quickly and efficiently to address unmet medical needs, making a real and lasting difference to patients and their families worldwide.