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Jul 09, 2023

China Launch Conference held for Ryzneuta®, Marking a New Era in Leukocyte Boosting Drugs

On July 9, the China Marketing Conference for the third generation long-acting granulocyte colony-stimulating factor (G-CSF), efbemalenograstim alfa injection (trade name: Ryzneuta), independently developed by Evive Biotech, a subsidiary of Yifan Pharmaceutical, was held simultaneously in Beijing, Shanghai, Guangzhou, Nanjing and Xi'an. The conference attracted hundreds of experts in various fields to gather for an academic event related to increasing white blood cell (WBC or leukocyte) counts for tumor patients and to witness the beginning of a new era for China's innovative drugs for increasing WBC counts. 

The conference was hosted by the Experts Committee on Leukemia and the Experts Committee on Lymphoma of the Chinese Society of Clinical Oncology (CSCO). At the conference, Academician Wang Xuehao, Academician Yu Jinming, Academician Ma Ding, Academician Teng Gaojun, Academician Xu Binghe, Professor Ma Jun, Professor Shao Zhimin, Professor Ye Dingwei, Professor Lin Lizhu, Professor Zhou Guoren and Professor Wen Aidong reviewed the development history of G-CSF, analyzed the pain points in increasing WBC counts after chemotherapy, comprehensively explained the clinical advantages of the third-generation G-CSF, efbemalenograstim alfa injection, and looked to the future of innovative drugs in China. 

At the opening ceremony, Dr. Simon Li, Chief Executive Officer and Chief Medical Officer of Evive Biotech, delivered a speech. According to him, the R&D of Ryzneuta took more than a decade and 12 clinical trials have been completed in accordance with the requirements of Class 1 macromolecular new drug R&D in China, the U.S. and Europe. Ryzneuta is the only drug for increasing WBC counts that has been evaluated in multiple head-to-head clinical studies compared with both brand-name short-acting and long-acting drugs of its kind. It has three advantages: better clinical efficacy, better safety and earlier administration and can help tumor patients to complete a full course of cancer treatment, thereby extending and saving more lives.  Further, Ryzneuta is expected to be the first Chinese independently developed macromolecular innovative drug approved for marketing in China, the U.S. and Europe, benefiting cancer patients around the world! 

In his speech, Professor Shao Zhimin, the principal investigator of the Phase III clinical study of Ryzneuta in China and Director of Fudan University Cancer Institute, expressed that through 13years clinical studies, efbemalenograstim alfa injection as a third-generation long-acting G-CSF has fully proved its efficacy and safety in preventing chemotherapy-induced neutropenia. He believes that its clinical application will benefit a large number of cancer patients. 


01/New era - Development history of G-CSF in China 
Professor Ma Jun, Director of the Harbin Institute of Hematology & Oncology, shared the development history of G-CSF in China: 
1) Before the discovery of G-CSF, hormones and other means were used to treat febrile neutropenia in China which produced limited clinical effects and significant side effects. 
2) The development of G-CSF began in the 1970s and spanned 50 years, with the first rhG-CSF, filgrastim, marketed in 1991, the first PEG-rhG-CSF, pegfilgrastim, marketed in 2002, and today, the third-generation G-CSF, Ryzneut a, marketed in 2023! 
3) Three clinical studies have shown that Ryzneuta can continuously and effectively reduce the incidence of moderate to severe neutropenia and has shown a better trend compared to filgrastim and pegfilgrastim. 
4) G-CSF drugs continue to evolve toward improved affinity, earlier administration after chemotherapy and enhanced efficacy and safety. The third-generation G-CSF will have broad prospects for clinical applications! 


02/The future is here - Comprehensive analysis of efbemalenograstim alfa injection 
Dr. John A. Glaspy, a global leading authority in the area of drugs for increasing WBC counts, the principal investigator of three global Phase II and Phase III studies of efbemalenograstim alfa injection, a key member of the NCCN Guidelines Panel for Hematopoietic Growth Factors, a member of American Society of Clinical Oncology (ASCO) and a professor of medicine at the UCLA Jonsson Comprehensive Cancer Center, shared the "Development History of Ryzneuta and Interpretation of International Research Data". He stated: 
1) As a third-generation long-acting G-CSF, efbemalenograstim alfa injection can meet the current clinically unmet needs and has shown a trend of superiority to pegfilgrastim and filgrastim in Phase III clinical studies; 
2) In the GC-627-05 study, a clinical trial comparing efbemalenograstim alfa with pegfilgrastim completed in Europe and the U.S., the primary endpoint was achieved with the efbemalenograstim alfa injection group being non-inferior to the pegfilgrastim group, and some other endpoints were potentially superior in the pegfilgrastim group; 
3) In Study SP11631, a clinical trial comparing efbemalenograstim alfa with filgrastim completed in China, the primary endpoint was achieved in the efbemalenograstim alfa group being non-inferior to the filgrastim group, and some secondary endpoints were superior in the filgrastim group; 
4) The results of a preclinical animal test have shown that efbemalenograstim alfa injection could significantly increase neutrophil counts when administered within 0-24 hours after chemotherapy. Further studies will be conducted to facilitate efbemalenograstim alfa administration following chemotherapy on the same day to further reduce medical expenses and benefit patients. 


03/Leading the future - Looking at the future of China’s bio-innovative drug development through Ryzneuta 
After decades of development, new drug R&D in China has entered a new stage and transitioned from "keeping pace" to "leading". 
Chaired by Professor Shen Jingnan and Professor Ba Yi, Professor Guo Ruyuan, Professor Li Guilin, Professor Ma Rui, Professor Sun Ping, Professor Sun Xiaonan, Dr. Chen Penggen and Dr. Simon Li engaged in a summit dialogue, "Looking at the Development of Chinese Biological Innovative Drugs via Ryzneuta" and discussed topics such as "how can Chinese independently-innovate drugs transition from keeping pace to leading" and "how can Chinese innovative drugs go global". According to the participating experts, more joint efforts from innovative pharmaceutical companies like Evive Biotech are needed for the transition from "me-too" to "me-better". 

1) First third-generation G-CSF-Fc from Evive Biotech - efbemalenograstim alfa injection 
Professor Song Yong from Jinling Hospital, Medical School of Nanjing University reviewed the 50-year development history of G-CSF and briefly described the differences between the first and second generations. He stated that the third-generation long-acting G-CSF, efbemalenograstim alfa injection, uses the Fc segment of IgG2 to replace PEG, which not only extends its half-life but also eliminates ADCC and CDC effects. Its brand-new bimolecular G-CSF design increases receptor binding probability, and its production process- (in mammalian cells) makes efbemalenograstim alfa closer to human-native G-CSF. Multiple clinical studies have shown that efbemalenograstim alfa can continuously and effectively reduce the incidence of neutropenia in cycles 2-4, with better safety compared to filgrastim. Eflapegrastim alfa is also the only G-CSF in China whose registration is supported by two global Phase III clinical trials with demonstrated safety and effectiveness when administered around24 hours after chemotherapy. As the world's first third-generation G-CSF-Fc fusion protein, efbemalenograstim alfa injection brings benefits including efficacy, safety and compliance through its three innovations. 
Afterwards, chaired by Professor Chen Ming and Professor Yao Yu, Professor Cao Baoshan, Professor Li Yan, Professor Sui Aixia, Professor Shi Qingming, Professor Wang Jue and Professor Yang Wenhui discussed the iterative changes of G-CSF and how the third-generation G-CSF addresses clinical pain points. According to the experts, the marketing of G-CSF brings hope of improving myelosuppression after chemotherapy to tumor patients. The second-generation G-CSF is longer-acting than the first-generation, however, it still causes intolerable adverse reactions in some patients. The marketing of this first third-generation G-CSF is a great uplift for clinicians. They look forward to more benefits to patients in the drug's future expanded clinical applications. 
2) Pharmacoeconomics of Ryzneuta 
Professor Liu Shiting from Nanfang Hospital, Southern Medical University stated that compared to short-acting G-CSF, long-acting G-CSF is more cost-effective on the premise of providing good efficacy and improving patients' quality of life. This conclusion has been confirmed in real-world studies conducted in China and in foreign health economics research. As the first third-generation G-CSF, efbemalenograstim alfa injection's comprehensive value is reflected in the multiple benefits brought by it and the drug will better support patients undergoing chemotherapy. 
Then, chaired by Professor Zhuang Li and Professor Liu Bo, Professor Bai Ou, Professor Cai Jing, Professor Ding Qingqing, Professor Li Guozhong, Professor Li Zhengfa, Professor Qiao Guangdong and Professor Wei Shuqing exchanged views on the value of efbemalenograstim alfa injection's three characteristics in pharmacoeconomics as well as the comprehensive value-oriented medical service. According to the experts, compared to the second-generation, the unique molecular structure and preparation process of the third-generation G-CSF leads to an extended action period, a reduced adverse reaction rate and an earlier administration window. In primary and secondary prevention, the drug can help patients to further save treatment expenses and can ensure the treatment regimen is carried out as scheduled, thereby providing more pharmacoeconomic benefits to patients. 


04/A better life with Ryzneuta 
In recent years, the burden of cancer treatment has become increasingly heavy in China; and there is still a long way to go in tumor prevention and treatment. On the other hand, the vigorous development of oncology in China continues to bring hope for a cure as well as better quality of life to patients. 
As a newcomer and a potential game changer in the field of innovative drugs, Evive Biotech of Yifan Pharmaceutical has independently developed the world's first third generation long-acting G-CSF, efbemalenograstim alfa injection, which potentially provides better efficacy and safety through structural and process innovations. The drug will become a sharp "weapon" for prophylactic increase of WBC countin clinical treatment, leading a new era in this field! 
At the end of the conference, Professor Zhu Jun delivered a concluding speech on behalf of the participating experts: the macromolecular biological innovative drug, Ryzneuta, independently developed by Evive Biotech not only ensures clinical efficacy but also exhibits better safety and convenience. He added that there are reasons to believe that Ryzneuta, as a third-generation G-CSF, has the potential to become  "best in class" and holds promise as a new clinical treatment option! He believes that with the clinical application in China and future launches in more countries, Ryzneuta will benefit patients worldwide and show China's innovation strength on the global stage. 



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