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Interview: Apollomics Poised to Bring China Developed Checkpoint Inhibitors to the US
In an exclusive interview with ChinaBio® Today, the leadership team of Apollomics, Dr. Guo-Liang Yu, Co-Founder and CEO, and Dr. Sanjeev Redkar, Co-Founder and President, described the company's execution of its innovative business plan. Apollomics focuses on bringing China-developed PD-1/PD-Li checkpoint inhibitors to the US market, the opposite of most young China biopharmas. The company seems almost to have anticipated the FDA's recent request for China biotechs to file NDAs in the US for their immunotherapies.
In January of this year, Apollomics announced a $100 million Series B round to develop its portfolio of three immunotherapies and three small molecule targeted candidates. According to Guo-Liang Yu, PhD, Founder and CEO of the company, "Apollomics has a business plan that is completely opposite to most young China biopharmas. Most companies in-license China rights to western candidates. Apollomics has out-licensed China rights to its major assets while it retained rights in global markets."
As Dr. Yu points out, the global rights are worth more. And the plan allows Apollomics to let its partners do the "heavy lifting" of putting the assets through clinical trials in China. The company plans to use the China-developed data to advance its candidates in ex-China markets, especially the US.
The US FDA Asks China Biotechs to File NDAs for PD-1/PD-L1 Candidates
Given its business plan, Apollomics was "very excited" to hear the FDA invite China biopharmas to file for approval of their PD-1/PD-L1 checkpoint inhibitors in the US. At the recent AACR meeting, Dr. Richard Pazdur, Director of the Oncology Center of Excellence at the FDA, said China PD-1/PD-L1 candidates could be approved in the US based on trials conducted in China, if the trials were "done right" (see story).
According to Dr. Pazdur, the FDA has approved five PD-1/PD-L1 molecules so far, but the price for each one is expensive and about the same as the others -- in other words, there is no price competition. A China-developed alternative would offer a similar drug at lower cost and put pricing pressure on all the drugs in the field, he said.
Dr. Yu believes Apollomics is probably one of the best positioned China companies to respond to the FDA's challenge. "Our checkpoint inhibitors, in the hands of our China partners, are both in Phase III and registrational trials; in fact, they are filing marketing applications this year, which means they will be products marketed in China," he said.
Sanjeev Redkar, PhD, MBA, Co-Founder and President of Apollomics, added, "These data are portable and will be useful for potential approvals in the US." The company is conducting biomarker-driven trials for specific indications, but he said Dr. Pazdur's statement "gives us an opening for a broader indication using clinical data from China. We'll have to see how they treat the data, but it is a fantastic opportunity for us.”
The Issue of Quality
However, according to Dr. Yu, the major challenge to securing approvals for biologic candidates in the US is not establishing the efficacy of the drugs -- he expects all checkpoint inhibitors, which have more or less the same mechanism, will produce similar results. He says quality, CMC, will be the major hurdle.
Dr. Yu said, "From a regulatory point of view, biologic drugs are very different from small molecules. There are hundreds of bioanalytical, QA, consistency tests -- each candidate must meet the compliance bar. It is a relatively new industry and the talent is just starting to return to China from the west. The infrastructure is just now being built to support biologic manufacturing."
For Apollomics in particular, Dr. Yu stresses the company has plans to build its biologics infrastructure. It has recruited a manufacturing team, not just for early development but for commercial development as well, and it is building a large manufacturing facility in Hangzhou, with a high quality design. Dr. Yu added, "We have recruited a staff including Dr. Yuling Li, who came from AstraZeneca with prior experience at GSK and Roche. Her life has been about large scale manufacturing of antibodies. We are definitely well-positioned."
The Hangzhou biologics manufacturing facility is being built close to the airport, which features a high-speed train depot, providing quick connections to eastern China. The facility is supported by local VCs and does not eat into the proceeds of the company's $100 million B round, which is earmarked for clinical trials.
Drug Combination Partnerships
The low cost of China-developed immunotherapies may also be attractive to companies with possible combinations therapies, Dr. Yu predicts. "If we move quickly into the US with a high-quality, low-cost PD-1, we anticipate there will be other companies who want to develop synergistic partnerships with us rather than high-priced multinationals," he said. Dr. Yu admitted that normally people don't play the cost card with a novel drug. "It's usually about the efficacy," he said. "But this is a special situation. It is is a very large market, and there is room for a cost play."
Dr. Redkar added, "We are learning a lot about combinations. We are learning what works, how some combinations seem not to work. We are absorbing that data and planning our trials accordingly. Antiangiogenic combinations seem to be consistently improving outcomes. Chemo combinations are also providing a benefit."
Overall, as a strategic plan for clinical trials, "We are looking for meaningful differences, small trials with large differences. As a small company, we will not do large trials that provide small differences," Dr. Redkar said.
Apollomics was spun out of CrownBio, a China preclinical oncology CRO. CrownBio started a drug therapeutic company, CBT Pharmaceuticals, with its own drug assets, which changed its name to Apollomics earlier this year when it raised $100 million in a Series B fundraising, appointed Dr. Yu as CEO and moved its headquarters to Foster City, California (R&D and manufacturing remain in Hangzhou).
OrbiMed was the largest shareholder of CrownBio. Dr. Yu is a Venture Partner at OrbiMed and was the Executive Chairman of CrownBio. OrbiMed Asia led the first financing round for CBT Pharma. With its investments in over 400 life science companies, OrbiMed, which continues to be Apollomics' largest shareholder, also offers suggestions for collaborations.
Dr. Jonathan Wang, Partner, OrbiMed and Chairman, Apollomics, had the vision of "Invented in China for the World" during the early start of Apollomics in 2016. Since OrbiMed Asia’s founding in 2007, the quality of China innovation has substantially improved. By 2016 and 2017, China was ready to bring products to global markets. "It is now fascinating to see the confirmation of our early belief in China innovation," he said.
Although Apollomics has made a point of out-licensing its China discovered assets to China while retaining the global rights for itself, it doesn't want to be known as a one-trick pony. "We are very open to taking assets from other countries back to China. We are actually eating lunch on both sides," said Dr. Yu. "We have a molecule that we are developing in both China and the US that will file in the US first, and then China later. We are also actively talking to US companies that are willing to out-license the China rights to other drugs."
Drs. Yu and Redkar both admitted they were pleasantly surprised at the comments from the FDA's Dr. Pazdur, mostly because regulatory officials, in both the US and China, are usually cautious about making competitive landscape statements. After reflecting, Dr. Yu said the comments were not shocking because, though unusual, they make perfect sense: "The US and China have the same need for high-quality innovative products that have to be made affordable. We must introduce products that are made in China to reduce costs for patients in the US. It is a change that both countries would like to see," he concluded.
As for Apollomics, they plan to launch their first drug on the market within two to three years. Its de-risked business plan may have run counter to the usual China biopharma startups, but it seems to have found itself in an enviable niche. "We feel this is an opportune moment for us," said Dr. Yu.
See our other articles on Apollomics.