TOT BIOPHARM is an oncology-focused biopharmaceutical company founded in 2010. Can you provide a brief company history and elaborate on the company’s cancer-fighting mission?

TOT BIOPHARM is a fully integrated drug development company that has been dedicated to the field of oncology since its establishment. Founded in 2010, our primary focus lies in the development, manufacturing, and marketing of drugs specifically tailored for cancer treatment. Our research and development team, as well as our manufacturing assets, are located in our stage one facility in Suzhou Industrial Park. These state-of-the-art facilities were completed in 2012 and notably include the first BSL-2 certified viral facility verified by the Jiangsu provincial government. By May 2018, we are scheduled to expand into our stage two facilities. At TOT BIOPHARM, we firmly believe in a multi-faceted approach to fighting cancer, which involves utilizing a combination of treatments. Additionally, we emphasize the importance of supportive care, encompassing not only physical health but also spiritual well-being.

Currently, TOT BIOPHARM’s only commercial product on the market is S-1. Can you elaborate on its capabilities and the rest of the company’s oncology-oriented pipeline?

We have obtained a license for S-1 from Taiho Pharmaceutical, a Japanese company, and we are responsible for marketing it in 22 different provinces within China. S-1 is primarily designed for the treatment of gastric cancer but has also demonstrated potential in addressing pancreatic cancer. As for our in-house developed products, we have submitted seven IND (Investigational New Drug) applications to the CFDA (China Food and Drug Administration), which includes four monoclonal antibodies (mAbs) and three small molecules. Six out of these seven applications have already received IND approvals from the CFDA.

Can you provide further insight into TOT BIOPHARM’s three core technology platforms?

TOT BIOPHARM relies on three core technology platforms to drive its oncology-focused endeavors. The first platform is the Monoclonal Antibody platform, which encompasses the development of antibodies, including biosimilars, new formulations/indications, and new biologics. Additionally, this platform includes Antibody Drug-Conjugates (ADCs). In April 2018, we proudly announced that our first ADC product had received clearance from the CFDA to proceed to the next stage of clinical trials. Our second platform revolves around the next generation Oncolytic Virus, which represents a highly innovative approach. In comparison to the first generation of oncolytic viruses, our version accomplishes dual-insertion of immune modulators. This unique feature enhances the immune response against cancer, providing us with a powerful tool in the fight against the disease. Lastly, we offer a small molecule platform that leverages Specialty Liposomal Drugs.

How does TOT BIOPHARM differentiate itself from other domestic manufacturers, and how are you strategizing to stay ahead in the continuously evolving oncology field?

TOT BIOPHARM recognizes the growing significance of biologics in the pharmaceutical industry. Among the top 10 products worldwide in terms of sales, eight are biologics. As an oncology-focused company, it is crucial for us to possess biologic capabilities to remain competitive in the market. Consequently, we have made significant efforts to bolster our capabilities in biologics since 2011. By prioritizing biologics, we aim to stay ahead of our competitors and effectively address the evolving landscape of oncology treatment.

The China Government has introduced many new regulations in support of innovation. Can you highlight a policy that has had a particular impact on TOT BIOPHARM?

One policy that has had a significant impact on TOT BIOPHARM is the introduction of the Marketing Authorization Holder (MAH) policy. Previously, the Chinese government favored locally-made products, and drug licenses were only issued to companies with manufacturing capabilities, rather than to the sponsors themselves. This meant that companies had to out-license their products to domestic manufacturers in China to access the market. However, with the MAH policy, sponsors now have the opportunity to find local domestic manufacturers to handle the CDMO (Contract Development and Manufacturing Organization) work while still retaining the drug license. This policy change has encouraged collaboration between small, innovative research companies and organizations like ours, ultimately accelerating the development of new products.

Looking towards the future, what is TOT BIOPHARM’s key objective, and where are the opportunities for the company to expand?

In May 2018, the Chinese government announced the cancellation of import taxes on cancer drugs, which is fantastic news for patients and hospitals as it allows for greater access to more advanced and higher quality drugs for combating cancer. TOT BIOPHARM sees this as a valuable opportunity to further focus on increasing global collaboration activities. We aim to introduce more promising candidates to the Chinese market through co-development of drugs with international partners. As we continue our mission to bridge combination treatments through a multi-platform approach, we are actively seeking novel technology platforms and pipelines. Additionally, this year, we are preparing for FDA pre-IND consultation and planning to make our first submission to the US FDA. Ultimately, our vision is to provide patients with high-quality, reasonably priced, and affordable treatment options.