On August 8, 2018 TOT BIOPHARM Company Limited ("TOT BIOPHARM"), headquartered in Suzhou Industrial Park, China, reported the completion of a Series B financing round, raising US$102 million in capital (Press release, Tot Biopharm, AUG 8, 2018, View Source [SID1234528578]). The financing round was supported by China Universal (Cayman) GP Limited and several renowned domestic and foreign investors, as well as investors who had participated in earlier rounds, including Center Laboratories Group, Vivo Capital, Chengwei Capital, Yuanta Financial Holdings Group and Cathay Capital. TOT BIOPHARM focuses on the R&D, manufacturing and marketing of high-end anti-tumor drugs. The company now has over 10 drugs in the R&D stage, including three biologics and three small molecules, which have received investigational new drug application (IND) approvals, as well as one antibody-drug conjugate (ADC), which is expected to receive approval soon. All project pipelines are meeting their milestones and all products on the roadmap are expected to reach the market according to their planned timelines.
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TOT BIOPHARM general manager Gloria Huang said, "With the completion of this round, we are very pleased to see that our achievements to date as well as what we foresee for the future have been recognized by several renowned domestic and foreign investors and continue to receive the support of our existing shareholders. The financing will allow us to accelerate development of our key pipelines. TOT BIOPHARM is taking advantage of the high-speed growth opportunities in China’s oncology market. In the future, we will also utilize the existing advantages of our established platforms to expand multi-perspective partnerships and cooperation at different levels, so that the benefits of resource integration will be maximized."
Vivo Capital, a major shareholder of TOT BIOPHARM, has partnered with the Series B investment team spanning several projects across multiple sectors. Existing shareholders and several renowned investors participated in the Series B round, fully demonstrating that investors have confidence in TOT BIOPHARM’s current achievements and future prospects. As a hi-tech company with the advantage of having built an integrated product R&D, manufacturing and marketing platform in the Chinese anti-tumor drug market, TOT BIOPHARM has been at the forefront of technological innovations and expansion into international markets for many years, and, as a result of having held steadfast to this approach, has achieved solid and steady progress. The firm has entered into strategic partnerships with several top-tier companies in the global anti-tumor sector. The completion of the Series B round will serve to accelerate the R&D of new products as well as the commercialization of existing ones, greatly improving TOT BIOPHARM’s competitive power and value."
TOT BIOPHARM recently announced results of the Phase I clinical trial (double-blind, head-to-head pharmacokinetics and safety comparisons) of Bevacizumab biosimilar, TAB008, at ASCO (Free ASCO Whitepaper) 2018, demonstrating that both in pharmacokinetics and safety indicators, TAB008 shows high similarity to Avastin. TAB008 is now in Phase III clinic trial, and, in terms of progress, TOT BIOPHARM is among the top three firms in China competing to get the drug on market. The financing will further accelerate the progress of TAB008’s Phase III study, as well as other R&D programs. The IND application for TAA013, an ADC, submitted by TOT BIOPHARM, is currently in the review process. With the higher threshold for manufacturing ADCs, the number of companies in China that can produce such drugs is quite limited. However, TOT BIOPHARM has its own manufacturing technologies and capability. The firm is in the process of ramping up production of its third-generation innovative oncolytic virus drug TVP211. Combined with its domestically leading BSL-2 certified virus manufacturing plant, TOT BIOPHARM plans to further accelerate the development program, taking a leadership position in this promising technology sector.
The construction of TOT BIOPHARM’s second-phase project – the monoclonal antibody R&D and manufacturing base was completed and put into operation in May 2018. The base, with a planned cell culture scale of up to 16,000L, was built in full compliance with international standards. Plans call for the establishment of three preparation production lines, responsible for the filling of drugs with different specifications. The facility also plans to successively launch a pre-filled preparation line, a lyophilized preparation line and a Grade OEL-5 plant for the mass production of ADC. The facility also has the flexibility to expand production capacities and adjust the layout of the production areas. Combining the existing 500L pilot plant, the facility is prepared to meet all demands for biologic drugs, from upstream R&D, pilot manufacturing, and clinical trial drugs to commercial production.
The completion of the financing is a major milestone in TOT BIOPHARM’s efforts to accelerate commercialization of product pipelines. Together with the international standards-compliant monoclonal antibody R&D and manufacturing base, TOT BIOPHARM will open its platforms for collaboration, making it the most distinctive company and the best strategic partner in the high-end oncology field.