Cellular Biomedicine Group (CBMG), a Shanghai-headquartered biopharmaceutical company, agreed to manufacture and supply Kymriah (tisagenlecleucel) in China, as well as seeing Novartis take a $40m (€34.49m) equity stake in the company.
On its end, Novartis will lead on the distribution and commercialisation of the product in China, as well as navigate the regulatory steps necessary to secure approval for the chimeric antigen receptor (CAR)-T treatment.
Shortly following this announcement, CBMG revealed it had arranged a non-exclusive licensing agreement with the National Cancer Institute (NCI) to develop, manufacture and commercialise neoantigen-reactive tumour infiltrating lymphocyte (TIL) technology.
Tony Liu (TL), CEO of CBMG, spoke to BioPharma-Reporter (BPR) about how each of these deals would help the firm grow into a leading biopharma company, and what can be expected to emerge from China in the cell therapy space.
BPR: Could you explain what is involved in CBMG’s deal with Novartis?
TL: CBMG has entered into a collaboration licensing partnership with Novartis, which is made up of three components:
- Novartis has made an approximate 9% stake into CBMG – in essence, saying: “We are not just entering into a manufacturing supply of Kymriah for China, but we are here with you long-term.”
- Novartis is a global leader in the pharmaceutical industry and, as the owner of the first globally approved CAR-T therapy – and a leader in this area – looked to China for a manufacturer with the scale and capability to supply the market – deciding on CBMG.
- Kymriah is a transformative treatment option, already approved in the US, Canada and Europe, but not yet in China. From Novartis' perspective, working with a local partner is important to bring this technology to the Chinese market.
BPR: Is the deal to manufacture exclusively for the Chinese market?
TL: Yes, at least at this point. I think we must first focus on the Chinese market manufacture and get that right but then we can go from there. From a cell therapy perspective, China and the Southeast Asian region has the second largest market, in terms of patient numbers.
BPR: Where will the product be manufactured?
TL: The manufacture will take place at our Shanghai facility – it is one of the largest facilities producing cell therapies in the world. The total cGMP (current good manufacturing practice) space is 70,000-square-feet, with 40,000-square-feet of this space dedicated to the production of CAR-T therapies.
BPR: How does Novartis' investment play into CBMG's plans for the future?
TL: CBMG's plan is to become a leading biopharmaceutical company and our core strengths are our R&D team and our manufacturing, which is key when producing cell therapies.
With this ambition, we have a broad range of cell therapies in our pipeline – from stem cell treatments to immune cell therapies. Within this, we have our own CAR-T investigational therapy (CD-19) that we have already begun investigating in Phase I clinical trials. We just announced a licensing agreement with the NCI for a non-exclusive deal for TIL technology and will be working together to use this technology for solid tumours.
BPR: With Novartis having acquired a substantial stake in CBMG, does this extend into sharing expertise or is it a purely commercial deal?
TL: As a shareholder, Novartis has an interest for us to continue to expand our pipeline and develop our own products. However, Novartis will not be involved in specific product developments – we are an independent company and a leader in this new space. On the other hand, though Novartis is not advising on product development, it does have the right to be the first to negotiate on any CAR-T therapies that CBMG brings to market.
BPR: How is China progressing as a developer of innovative therapies?
TL: We have many young, innovative biotech companies in China and there are a number of companies developing their own, unique technology. From a cell therapy perspective, we believe China has tremendous strengths because it can rely on employee talent, which it has in abundance, and infrastructure, such as the high-speed train delivery. In addition, China, at a national and provincial level, has invested heavily in 'biotech zones'. With all three of these factors coming together, it has created a cluster of new biotech companies – CBMG is one such company.
Specifically, in cell therapies, this is an area where China could take the lead. When it comes to solid tumours, the country has such issues, social and economic, that we really need to focus on cancer treatment; this will see China pool its resources together, from a science, technology and manufacturing basis to develop its biotech industry and apply it to these issues we're facing.
Tony Liu had been serving as an independent director and chairman of the audit committee for CBMG since March 2013 and was appointed as CFO in January 2014. He was appointed CEO of the company in February 2016. He formerly served as the corporate vice president at Alibaba Group responsible for Alibaba’s overseas investments.