The sentence heard most often in 2019 is "I'm too difficult", but it's not true
2019 annual year-end review meeting of China's biological products industry
As time passes by, we're in 2020 suddenly. Looking back the past year, the sentence we heard most often in 2019 is "I'm too difficult", but for those of us in the biopharmaceutical industry, it is a year of rising to the challenge and fighting. Next I will lead us to take a look at what happened in China's biologics industry last year that we should remember.
Part 1 丨McAb(monoclonal antibody)
Domestic McAb(monoclonal antibody) is multifarious
On December 28 2019, BeiGenne announced that its PD-1 drug "Baezean" (General Name: Tislelizumab Injection) had been approved by the National Medical Products Administration (NMPA) on December 27, making Tislelizumab the seventh domestic monoclonal antibody approved for market.
At the end of 2018, monoclonal antibodies of Junshi biosciences Co., Ltd and Innovent Biologics, Inc. were approved for market successively.
- In February 2019, Rituximab of Shanghai Henlius Biotech, Inc. was approved.
- In May, Camrelizumab of Hengrui Pharmaceutical was approved for the market;
- In November, Adalimumab of Hisun Pharmaceutical Co., LTD. was approved;
- In early December, Bevacizumab of Qilu Pharmaceutical Co., Ltd was approved.
With the addition of BeiGenne, the seven domestic monoclonal antibodies cover four targets. The monoclonal antibody industry has a good future. We expect more different monoclonal antibodies in 2020!
Domestic HPV vaccine and PCV13 vaccine come out.
On the last day of 2019, State Drug Administration (SDA) approved Xiamen Innovax Biotech CO., LTD’s application for listing bivalent human papillomavirus vaccine (e. coli) (Trade Name: Cecolin). The drug is the first domestic human papillomavirus vaccine to be approved for use in women aged 9 to 45.
Only two days later, the first domestic 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) independently developed by Yunnan Walvax Biotechnology Co., Ltd was approved for market. PCV13 not only broke the international monopoly, but also greatly alleviated the shortage of domestic 13-valent pneumococcal vaccine and filled the "gap" in China's current children's pneumococcal vaccine.
Consistency evaluation of vaccines coming
“The vaccine management law” came into effect on December 1, which will exercise strict control over the entire process, entire process and entire aspects of vaccine implementation.
China's State Food and Drug Administration (SFDA) released the "technical guidelines for clinical comparability studies on preventive vaccines" on December 24, aiming to further standardize and improve the level of clinical research and development of preventive vaccines, ensure similar vaccines have similar safety and effectiveness, and strengthen vaccine quality and safety supervision.
This means that after generic drugs, consistency evaluation of vaccines will begin.
Part 3｜Capital Market
Biopharmaceutical companies concentrate on listing in Hong Kong
On September 25, 2019, Shanghai Henlius Biotech, Inc. (hereinafter referred to as " Henlius ") was officially listed on the Stock Exchange of Hong Kong Limited. As a R&D pharmaceutical enterprise incubated by Fosunpharma, Henlius has become the ninth unprofitable biotechnology company listed on the Hong Kong, following Ascletis Pharma Inc., Hua Medicine, Innovent Biologics, Inc., CanSino Biologics Inc, BeiGenne, Shanghai Junshi biosciences Co., Ltd, CSTONE PHARMACEUTICALS and Mabpharm Limitied.
With the policy opening, HKEX has also become an option for many would-be listed companies. Since then, Totbiopharm and Alphamab Co. Ltd listed in November and December respectively. At present, innovative pharmaceutical companies such as Ascentage Pharma, China Antibody, Venus Medtech and Tasly Pharma have submitted their applications for listing in Hong Kong.
WuXi Apptec Co., Ltd. took stakes in Jiangsu Hanbon Sci.& Tech. Co.,Ltd
China's pharmaceutical equipment has always been dependent on imports, especially the biological products industry. The imported equipment is not only expensive, but also inconvenient to maintain and costly to repair. However, it is the choice of many pharmaceutical enterprises due to its stable performance. However, in recent years, with the rise of local pharmaceutical equipment enterprises with strong innovation ability, such as Jiangsu Hanbon Sci.& Tech. Co.,Ltd, the self-developed innovative equipment has injected new strength into the domestic pharmaceutical equipment market, and has been verified in the production practice. It has been recognized by more and more pharmaceutical enterprises.
In November 2019, Shanghai WuXi Apptec Co., Ltd. took stakes in Jiangsu Hanbon Sci. & Tech. Co.,Ltd, which fit the spirit of “Made in China 2025”. They will integrate and promote each other, improve the quality of domestic pharmaceutical equipment, promote product update and iteration, enhance the overall strength of China's pharmaceutical industry, and benefit China and the world.
Piaoyang Sun and Dechao Yu at CCTV
On November 3, 2019, CCTV Finance “Dialogue” invited Piaoyang Sun of Hengrui Pharmaceutical and Dechao Yu of Innovent Biologics, Inc. to talk about the acceleration of innovative drugs.
There are big hope in the little medicine bottles. The two masters both showed up with their companys’ Innovative anticancer drug (Camrelizumab of Hengrui Pharmaceutical, Sintilimab of Innovent Biologics, Inc.).
Behind each innovative drug, the pharmaceutical company invests a huge amount of time, capital and manpower. According to Piaoyang Sun, hengrui has spent about 10 years, invested nearly 2 billion RMB, and involved nearly 1,000 people. According to Dechao Yu, Innovent has invested nearly 1.5 billion RMB from the establishment of the project in 2012 to its listing in 2019.
The world's top 50 pharmaceutical companies in 2019
On June 11, Beijing time, 《Pharmaceutical Executive》, a magazine of the United States, announced the latest edition of the world's top 50 pharmaceutical companies in 2019. Every year, 《Pharmaceutical Executive》ranks the top 50 pharmaceutical companies according to the global prescription drug sales of each biopharmaceutical company, ranking relatively stable. But this year, two Chinese companies are listed for the first time, namely China Biopharmaceutical and Hengrui Pharmaceutical.
Single Use System (SUS) was launched by Hanbon
Single Use System (SUS) has been widely used in the field of biopharmaceutical, featuring flexible operation, safe use, no risk of cross-contamination, the avoidance of CIP/SIP, the reduction of cleaning verification, and greater efficiency and flexibility. As a supplier of downstream purification equipment for biopharmaceutical, Jiangsu Hanbon Sci. & Tech. Co., Ltd has invested in the research and development of the Single Use System (SUS) for meeting the customers’ needs of multi-product collinear and filling the domestic gap. Hanbon launched the single use ultrafiltration UF/DF system in mid-December. The single use chromatography system is being developed and is expected to be launched in the second quarter of 2020. Stay tuned.