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JW Therapeutics (Shanghai) Co. Ltd. expects to submit the marketing application in 2020 for its first chimeric antigen receptor T cell therapy, which uses a patient's own modified cells to treat cancer. The company bought the licensing rights to develop the therapy from Juno Therapeutics Inc.

➤ The company plans to file a clinical trial application for another drug candidate licensed from Juno Therapeutics in early 2020.

➤ Costs for CAR-T therapy will likely fall significantly in the U.S. and China over the next three to four years, said CEO James Li.

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James Li, co-founder and CEO
Source: JW Therapeutics

Shanghai-based JW Therapeutics is a gene and cell therapy venture between Seattle-based Juno Therapeutics Inc. and WuXi AppTec Co. Ltd.

The venture was established in 2016. Singapore state fund Temasek and private investment company Sequoia Capital China are some of the institutions that have invested in JW Therapeutics.

The joint venture bought the rights to commercialize all of Juno Therapeutics' products in China. JW Therapeutics's first product — CAR-T therapy JWCAR029, is undergoing a phase 2 trial.

CEO James Li, who co-founded the company, was previously founding general manager of Amgen Inc. China from 2012 to 2015. Prior to Amgen, Li spent more than 15 years with Merck & Co. Inc., where he held leadership positions in clinical research, regulatory affairs and other areas.

Li spoke to S&P Global Market Intelligence about the company's strategy as well as his take on China's evolving gene therapy market. Below is an edited transcript of the interview.

S&P Global Market Intelligence: What are your expectations about commercialization of the company's first CAR-T treatment? What will be the likely price range?

James Li: We will start commercializing JWCAR029 sometime in late 2020 or early 2021. We certainly hope it will be the first CAR-T therapy to be approved in China. We will definitely be in the first batch [of companies] to receive approval.

I don't think companies like JW Therapeutics will look at government reimbursement [schemes] when we launch our products in China. It's just not practical. We will actively work with private insurance companies along with the government to find a way to market our CAR-T therapy.

In the short term, I think our therapy will be paid for by patients. Our therapy will definitely not be as expensive as Novartis AG's Kymriah priced at $300,000 in Japan, but it also won't be as low as say, 100,000 yuan. In the long term, it is possible that CAR-T therapies could get into the national drug reimbursement list in China as the country slowly expands coverage of state health insurance.

How do you expect to make CAR-T therapy more accessible in China?

We have started looking at how to reduce costs potentially by up to 70% to make the treatment more affordable in China.

Automating the process is definitely one approach, while improving it is another. The process of drawing blood from patients and transfusing the blood back [with modified cells], for example, can take 21 to 27 days. If we can halve the cycle to about 14 days, that could reduce the cost.

In the next three to four years, I expect to see CAR-T therapy costs drop dramatically not just in China but in the U.S. as well.

How do you see the competition landscape for gene therapy? What is JW Therapeutics' game plan?

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I don't see huge competition or a potential price war in the short term. I think the Chinese CAR-T market is still very much in its infancy.

In the U.S., we have seen very clear differentiation among major products in CAR-T in terms of efficacy, safety, durability and supply dependability. The manufacturing processes and quality control are different. We should see a similar situation in China.

However, cost will also play an important role in the Chinese market. In the U.S., CAR-T therapy can be reimbursed by health insurance, which is not the case in China.

JW Therapeutics is looking at introducing two Juno therapies. We are working on the second product and plan to file an application for a clinical trial early next year.

In the long term, we are open to working with other cell therapy companies to bring their products to China as well.

What are the challenges that companies like JW Therapeutics face in China?

Manufacturing and logistics are an integral part of the process for developing CAR-T therapies, unlike antibodies. The whole treatment paradigm is different from other kinds of treatment, and increases the complexity of supply chains and patient management. It is also hard to build a team [in China] as not many people know how to do that.

Gene therapy also requires an intensive study of biomarkers, which requires regulatory approval. If you want to study a big pool of biomarkers, the regulatory approval process can be time-consuming.

As of Oct. 17, US$1 was equivalent to 7.08 Chinese yuan.