Even though China’s pharmaceutical sector remains largely generics-based, the Middle Kingdom’s biotechnology scene has been flourishing in recent years. Now the world’s fastest-growing biopharmaceutical market, China can boast a much-improved context in terms of drug regulation, ease of doing business, research capabilities and access to capital. Below, we highlight 5 of its most innovative and important biotechs.
Firstly, the Chinese government introduced sweeping reforms to move the country from an imitator to an innovator in pharmaceutical drug development. The critical turning point was when the country joined the International Council on Regulatory Harmonization (ICH) in 2017, driving harmonization of the Chinese National Medical Products Administration (NMPA)’s regulations with global norms.
The Shanghai Center of Biomedicine Development inside the Zhangjiang Hi-Tech Park is just one example of state-backed organizations lending a helping hand to the biotech ecosystem
Secondly, launching a biotech company has become a walk in the (science) park thanks to public programs granting innovative projects access to startup funds, offices, laboratories, administrative support and other services. The Shanghai Center of Biomedicine Development inside the Zhangjiang Hi-Tech Park is just one example of state-backed organizations lending a helping hand to the biotech ecosystem.
Thirdly, performing clinical trials in China is not as difficult as it used to be due to the development of clinical research centres and of a competent local CRO industry. Moreover, fishing for talents experienced in drug R&D and commercialization is now easier thanks to a wave of foreign-educated returnees with successful careers at multinational companies both in the West and in China who are jumping on the bandwagon of local biopharmaceutical innovation.
Finally, venture capitalists have sniffed the money-making opportunities of China’s biotech sector and have poured massive funds into the mix. Easier access to capital markets for pre-revenue Chinese biotech companies in Hong Kong and soon, in Shanghai has also contributed to this influx of cash. In total, USD 40 billion was raised for Chinese life sciences in 2017, the final ingredient in a recipe for success.
All of these factors have turned China into the world’s fastest-growing biopharmaceutical market. As a result, the number of patent filings and clinical trials has skyrocketed in recent years. As an example, China has surpassed the US in terms of biologics patent filings and had over 650 biologics in clinical trials at the end of 2018. Furthermore, there are over 400 monoclonal antibody products in development in China, especially ones targeting PD-1/PD-L1. There were 126 PD-1 studies conducted by Chinese biotech companies as of January 2018 and CAR-T was another particularly busy area, with 116 clinical trials conducted in 2018, compared to 96 in the US.
In this crowded space, it can be hard to separate the wheat from the chaff. This is why PharmaBoardroom has selected the 5 Chinese biotech companies that stand out from the crowd, either through their disruptive research, commercial success or innovative business models.
Established in 2011, Innovent has taken on the mission to develop and commercialize high-quality biopharmaceuticals that are affordable to ordinary people in China and around the world.
Even though China is considered the factory of the world, today no Chinese-manufactured biologic is available in developed markets. In order to change this state of affairs, Innovent has built a fully-integrated platform of drug discovery, cell line and process development, manufacturing, quality control and clinical development capabilities in compliance with global standards. The company now has a pipeline of 17 promising antibody and other biologic drug candidates in the fields of oncology, ophthalmology, autoimmune and metabolic disease. Four core products are in late-stage clinical development in China and two have NDA approved by the NMPA including one with priority review status.
Innovent has managed to assemble an impressive team of international talent, including many expert returnees with experience across the entire value chain. The company has also entered into key strategic alliances with Eli Lilly, Adimab, and other biopharmaceutical companies
Innovent successfully went public on the Hong Kong Stock Exchange in October 2018.
Zai Lab’s founder & CEO Samantha Du has quickly risen as one of the stars of China’s biotech sector. She previously started the highly successful companies Hutchison China MediTech and led healthcare investments at Sequoia China for a several years.
Founded in 2014, Zai Lab is trying to establish itself as the “Gateway to China”. The company has found rapid success by in-licensing from both Big Pharma and other biotechs the development and marketing rights of promising drug candidates in oncology and other treatment areas for the Greater China and Asia Pacific territories.
The company is about to commercialize its first drug in mainland China: earlier this year the NMPA granted priority review to its NDA application for ZEJULA, a drug for ovarian cancer in-licensed from Tesaro, already marketed in Hong Kong since 2018. More are coming as the company has ten Phase III studies ongoing.
The company’s in-house R&D team has now started to work on discovering new compounds. Zai Lab has been quoted on the NASDAQ Stock Exchange since 2017.
Founded in 2009, Alphamab Oncology has developed a robust pipeline of about 30 biosimilars and 20 innovative biologics programs, most of them in immuno-oncology. To put things into perspective, their biosimilars pipeline represents almost half of all biosimilars in development in China!
By October 2018, the company had already applied for 47 domestic and foreign patents, and obtained four clinical approvals for drugs, including two clinical approvals for innovative drugs. Among these four drugs, three of them are antibodies targeting PD-L1, CTL-4 and HER-2. Although a lot of biotech companies are racing to launch similar drugs in China, Alphamab is well-positioned to take the crown.
As Founder & CEO, Xu Ting, says “even though the PD-1 space is so crowded at the moment, we are confident that our late-stage oncology products are very differentiated”. For instance, their late-stage PD-1 candidate, KN035, is a subcutaneous injectable instead of the standard IV infusion, which the company expects to have a large clinical impact. It plans to file for NDA for this drug in Q4 2019 and launch it in the Chinese market subsequently.
They also have another product, a PD-L1 CTL-4 bispecific, with huge potential to be superior in terms of safety and efficacy, in addition to being the only bispecific candidate in this class globally. Moreover, it is the only bispecific candidate in this class globally. Alphamab is not only focused on China as their products are also in development for the US market.
In November of last year, the company pulled off an impressive USD 100 million series A financing round putting the company at a significant advantage in the race to become the Chinese leader in immuno-oncology.
Diabetes is a growing pandemic in China. China now houses a quarter of the world diabetes population with over 114 million patients (11.6 percent of China’s population), a number that is increasing at a 10 percent annual rate.
Hua Medicine has developed a first-in-class drug called dorzagliatin that could revolutionize the treatment of type 2 diabetes. While others have failed for the past 30 years to develop a safe and efficient glucokinase activator (GKA), Hua Medicine has finally succeeded by using a novel approach.
As a result, the company’s compound manages to reduce blood sugar levels and improves insulin sensitivity without causing hypoglycemia. Hua Medicine has almost completed Phase III clinical trials in China and is running Phase I trials in the U.S. What is impressive is that this drug could be used in combination with existing diabetes treatments such as insulin, metmorfin and DDP-4 inhibitors. Based on the highly positive results, Hua Medicine is confident that combination therapy with dorzagliatin could rebuild patients’ blood glucose control mechanisms and potentially even reverse type 2 diabetes.
Using what they have learned in the development of this drug, Hua Medicine’s research teams are now using a similar approach to improve glucose metabolism in the brain in order to fight against various Central Nervous System disorders.
Many in the industry have realized the game-changing nature of Hua Medicine’s research and decided to support it. The company’s investors include some of the top venture capital firms and Chinese companies such as WuXi AppTec, a leading local CRO, and Ping An, a giant conglomerate with health insurance and online health subsidiaries.
It is hard to categorize Harbour BioMed as purely a Chinese company. Established only in 2016, the company’s first move was the acquisition of the Netherlands-based fully human transgenic antibody technology company, Harbour Antibodies BV and its subsidiaries.
Harbour BioMed is now a global biopharmaceutical company with locations in Shanghai, Amsterdam and Boston. The company develops innovative therapeutics in the field of immuno-oncology and inflammatory diseases. Its discovery and development programs are centered around its two patented transgenic mouse platforms generating fully human monoclonal antibodies. The company is building its proprietary pipeline internally, through collaborations with co-development partners, as well as through selected preclinical and clinical stage asset acquisitions.
It now has a large portfolio of pre-clinical and clinical assets, including a Phase II for its innovative drug candidate for the treatment of inflammatory eye disease. Harbour BioMed also licenses its technology platforms to companies and academic institutions through its Harbour Antibodies subsidiary.