The AIM platform focuses on the design of multifunctional biological products for cancer immunotherapy by incorporating the innate immune system. By targeting innate immunostimulators rather than adaptive immunostimulators,

which are considered to be more cytotoxic and susceptible to tumor immune escape and immunosuppressive TME suppression, products developed by the AIM platform are expected to achieve the desired clinical safety and efficacy.

Product pipeline rich core product highlights

With the support of its three technology platforms, Shenghe Bio has identified and developed nine pipeline products. Among the nine pipeline products, there are three core products,

In addition to these core products, the company has six product candidates, including clinical stage products IBB0979, IBC0966 and IBD0333, and preclinical stage products IAN0982, ISH0988 and ISH0613.

Generally speaking, to judge the development potential of a biopharmaceutical company, it can be judged from the dimensions of innovation, research and development progress, and competitive advantages compared with similar products. Newer, faster, stronger products tend to have higher value. Below, we will analyze several of the company's core products one by one.

ADCC enhances antibody IAH0968

IAH0968 is an ADCC enhancing antibody that targets human epidermal growth factor receptor 2 (" HER2 ") with 100% fucosaccharide knockout and greatly enhanced binding affinity of its crystallizable fragment (" Fc ") to the receptor FCγriiia.

It is understood that antibodies are composed of antigen-binding fragments (" Fab ") and Fc two structural regions. The Fab region defines specific targets for antibodies, while the Fc region activates the immune system by binding to various Fc receptors,

thereby mediating ADCC. Among the current methods for enhancing ADCC activity, modifications to remove fucose have been shown to be desirable and are widely tried by the biopharmaceutical industry. However, most of the resulting antibodies still contain some proportion of core fucose.

By constructing a new cell line with mutated FUT8 fragment, Shenghe Biology effectively solved the technical problem of core fucose residue and successfully prepared the first anti-HER2 antibody, IAH0968, which has the potential to remove 100% fucose from its Fc region.

Data from preclinical studies show that IAH0968 has 10-20 times greater affinity with its Fc receptor than with unmodified or other ADCC-enhancing anti-HER2 antibodies.

Phase I clinical data showed that patients with metastatic BTC and CRC who had failed multiple front-line therapies with IAH0968 monotherapy had an objective response rate of 40% and disease control rate of 80%.

In terms of drug research and development progress, IAH0968 is also at the industry-leading level. Globally, three anti-HER2 antibodies have been approved and three anti-HER2 antibodies for cancer treatment are in clinical development,

with the most advanced products in phase II/III clinical stages, according to Frost & Sullivan. Currently, three anti-HER2 antibodies have been approved in China, and four anti-HER2 antibodies are in clinical development,

with the most advanced products also in phase II/III. Among all anti-HER2 antibodies, IAH0968 performs well, becoming the only and fastest clinically advanced ADCC enhanced anti-HER2 antibody by removing fucose modification in China and even in the world, and is currently in phase II/III clinical stage.

Antibody cytokines IAP0971 and IAE0972

As potent immune mediators that play an important role in controlling the growth and activity of immune system cells, cytokines have long been viewed by researchers as promising candidates for developing therapeutic drugs.

However, because cytokines are active on many different cell types and tissues, they can cause systemic rather than local activity. In addition, cytokines are biodegradable and most of them have very short half-lives in the body. Therefore, cytokines are a double-edged sword in regulating the immune system.

Through the exquisite design of sequence, spatial structure and protein modification, Shenghe Biology has developed antibody cytokines that can co-express antibodies and cytokines into a fusion protein. IAP0971 and IAE0972 are the two products developed by Shenghe Biology.

These cytokines function through different mechanisms of action but have similar structures, including antibody or quasi-antibody groups that target tumors and block signaling pathways that regulate tumor growth and proliferation,

as well as cytokine payloads that activate the immune system within the tumor microenvironment (" TME "). Through this design, it is expected to overcome the disadvantages of short half-life,

systemic cytotoxicity and low efficacy due to cytokine pleiotropy and off-target effects of traditional cytokine drugs, so that the cytokine can achieve a better balance in safety and effectiveness, so as to achieve enhanced anti-tumor effects.