There are more than 95 plus major players and more than 90 plus nonalcoholic steatohepatitis (NASH) pipeline therapies, but none of them has been approved for marketing. Who would survive the competition in the blue-ocean market for NASH?
Sino Biopharmaceutical Limited (Chinese:中国生物制药有限公司, 01177. HK) on April 26 announced that its affiliated company Chiatai Tianqing (Chinese: 正大天晴, CTTQ) had signed the exclusive license and transfer agreement with Ampsource Pharmaceutical Technology (Shanghai) Co., Ltd (Chinese:安源医药科技（上海）有限公司, Ampsourcebio) for the development and commercialization of new biological medicine AP025 and AP026 in China and some Asian regions for the treatment for nonalcoholic steatohepatitis and type II diabetes (T2DM).
At present, the Phase I clinical trial on AP025 has been conducted in China and the phase I clinical trial on AP026 has been carried out overseas. Plans have been laid out to apply for IND (investigational new drug) in China in 2022.
AP025 and AP026, two recombinant fusion proteins, are the potential treatment for T2DM and NASH. NASH is the late-developing stage of nonalcoholic fatty liver disease (NAFLD), which can lead to advanced liver fibrosis, liver cirrhosis, liver failure, and liver tumor.
NAFLD is the most common chronic liver condition. It is estimated that the incidence of NAFLD in the world is 25% and that in China is 20%. Of the stricken populations with NAFLD, about 10%-30% will develop into Nash.
In the past 20 years, the incidence of NASH in Western countries has doubled, and China is expected to have more than 30 million patients with NASH. Obesity, type II diabetes, hyperlipidemia, and hypertension are the three major risk factors for NAFLD.
The incidence rate of NAFLD among obese people is as high as 70%. With the continuous increase in obesity, the prevalence of NAFLD is on the rise. According to EvaluatePharma, the global pharmaceutical market of NASH will reach USD 40 billion by 2025. Nonetheless, FDA has not approved, as of yet, any therapeutic drug for NASH, indicating a huge clinical demand.
Medical industry observers pointed out that cooperation is a win-win situation for the two companies. Ampsourcebio is committed to the research and development of high-end recombinant proteins. Its technologies and products lay a foundation for the research and development of AP025 and AP026.
They include platforms for Chinese hamster ovary cell (CHO) production cell line efficient development, high-affinity antibody development, super long-acting protein design and bispecific antibody technology.
CTTQ is a multinational pharmaceutical company with integrated R&D, manufacturing, marketing, sales and distribution capabilities. With more than 14,000 employees, CTTQ has a leading market position in medicines for the treatment of liver disease and can support Ampsourcebio to bring AP025 and AP026 to more patients.
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Source: NASH Pipeline (natap.org)