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Domestically Developed Bevacizumab Set to Reduce Cancer Treatment Costs in China

Nov 22, 2018 08:40 CST Updated 08:40
Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

  【China Pharmaceutical Network - Industry Dynamics] On October 17, the Center for Drug Evaluation of the China Food and Drug Administration announced that Qilu Pharmaceutical’s recombinant humanized monoclonal antibody injection against VEGF (bevacizumab) had been included in the 33rd batch of drug registration applications under the priority review program.
 
This also means that bevacizumab is finally poised to become domestically produced in China, which is good news for patients with advanced-stage cancer in the country. Once launched on the market, bevacizumab is expected to further reduce the financial burden on patients, improve drug accessibility, and benefit a larger number of cancer patients in China.
 
It is understood that bevacizumab, as a representative anti-angiogenic agent for cancer treatment, is widely used in the management of various malignant tumors. For instance, bevacizumab is a highly recommended therapeutic regimen for metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, renal cell carcinoma, ovarian cancer, and cervical cancer.
 
Bevacizumab was initially developed in the United States and has become a cornerstone medication for anti-tumor therapy in European and American markets. According to statistics, its global sales in 2017 amounted to approximately USD 7 billion, equivalent to RMB 49 billion. Recent data indicate that the number of cancer patients in China has been increasing year by year, leading to a continuous expansion in demand for such drugs. Evidently, bevacizumab holds considerable market prospects in China. Consequently, as the patent expiration of this product approaches, an growing number of domestic enterprises are targeting the research and development of its biosimilars.
 
Industry analysts suggest that with the market entry of more bevacizumab biosimilars offering equivalent quality and a price advantage, the number of cancer patients receiving anti-angiogenic therapy will increase substantially, benefiting over 100,000 individuals annually and further enhancing drug accessibility.
 
According to the author’s research, more than 20 companies in China have currently filed applications for bevacizumab formulations. Among them, Qilu Pharmaceutical has taken the lead by completing clinical trials and submitting a marketing application. Infolife Biopharma, Hualan Gene, Boan Biotech, Jiangsu Hengrui Medicine, and Henlius Biologics are closely following, conducting relevant clinical trials.
 
Innovent Biologics
 
According to the prospectus, Innovent Biologics has established a product development pipeline comprising 17 antibody drug candidates, four of which are core products currently in late-stage clinical development in China, including the biosimilar bevacizumab (Avastin) IBI-305.
 
Hualan Gene
 
It is reported that Hualan Biological Engineering Inc. has established Hualan Vaccine Co., Ltd. and Hualan Gene Engineering Co., Ltd. to strategically position itself in the vaccine and monoclonal antibody sectors, thereby achieving a comprehensive biological portfolio encompassing blood products, vaccines, and biopharmaceuticals, and cultivating new profit growth points for the company. Among its monoclonal antibody projects, bevacizumab has received approval for clinical trials and is currently in Phase III clinical development, with market approval expected in 2020.
 
 Boan Biotech
 
Boan Biotech’s recombinant humanized anti-VEGF monoclonal antibody injection – LY01008 project entered Phase I clinical trials as early as 2017.
 
 Hengrui Medicine
 
On March 14, 2018, Hengrui Medicine issued an announcement stating that the company and its subsidiary, Shanghai Hengrui Pharmaceutical Co., Ltd., would soon initiate Phase III clinical trials for Bevacizumab Injection. As of the date of the announcement, the company had incurred approximately RMB 32.9 million in research and development expenses for this project.
 
 Henlius
 
In April 2018, HLX04 (recombinant humanized anti-VEGF monoclonal antibody injection), a bevacizumab biosimilar developed by Henlius Biopharma, completed Phase I clinical trials. In May, the company announced the official launch of Phase III clinical trials for the indication of metastatic colorectal cancer.
 
It is reported that HLX04 is the fourth biosimilar independently developed by Henlius and the company’s fourth product to enter Phase III clinical trials.