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China's Glut of PD-1/PD-L1 Candidates -- How Can They All Find a Market?
In China, 67% of biotech companies focus on oncology, and most of them are developing a PD-1/PD-L1 candidate. There are 45 companies working on PD-1/PD-L1 antibodies with more than 100 clinical trials underway as of March this year, according to Frank Jiang, CEO of CStone Pharma (HK: 2616). Dr. Jiang spoke as a panelist at the Chinatrials 12 Summit held in Shanghai recently. In the panel discussion, written up in BioWorld, Participants were asked how China biotech companies with PD-1/PD-L1 candidates could hope to differentiate their products, given that almost every company seems to have a PD-1/PD-L1 candidate in development (see story).
The problem is fairly evident. Jing He, an oncologist and site head of pharma development in Shanghai for Roche China, said China's PD-1 market is already fiercely competitive with five approved products and BeiGene's PD-1 candidate expecting approval in China before the end of the year.
Having too many similar drug candidates “is not a sustainable economy,” added Ling Su, a venture partner at Lilly Asia Ventures. “Sometimes it’s even unethical to subject patients to a new class since you already have products on the market.” It may be time to stop development of close-following PD-1/PD-L1 antibodies, he said. “Some biotech companies need to say no and just realize that they might be too late for this.”
Nevertheless, biotechs remain hopeful. Every company is ready to propose an answer, depending on its own strategy. For Jiangsu Hengrui Medicine, “The key to standing out is to find a combination therapy with PD-1,” said Lianshan Zhang, senior vice president and global R&D president at Hengrui. A PD-1 can be a backbone therapy and companies can find a niche, depending on the combination, he added.
Hengrui's PD-1 candidate, camrelizumab, was approved as a third-line treatment for recurrent or refractory classical Hodgkin lymphoma in China in June. Now, the drugmaker to co-developing a therapy that combines camrelizumab with revoceranib, an EGFR-2 inhibitor developed by LSK, for patients with advanced hepatocellular carcinoma.
And, to make sure that all the bases are covered, Hengrui is also developing an PD-L1 and has a bispecific antibody that simultaneously targets PD-L1 and TGFbetaR2.
For 3D Medicines, the strategy is clinical profiles. “We can see whether it can improve efficacy, safety or patient compliance,” said David Liu, chief medical officer at 3DMed. The company is developing the first subcutaneous injection PD-L1 drug, which it believes will bring greater convenience and cost benefits to patients.
The oversupply of PD-1/PD-L1 antibodies implies that China biotechs are bogged down trying for incremental innovation rather than undertaking profoundly novel projects, a longstanding problem. Looking at the situation positively, it could be said these company are starting with fast follow-up drugs, using them to build up their R&D expertise. In the future, they could expand into developing first-in-class and best-in-class assets.
Hengrui’s Zhang believes preclinical discovery is the secret for truly novel candidates. "We need to leverage our knowledge in selecting targets and disease areas,” he said, identifying niche areas to stand out from the crowd.
3DMed has a more comprehensive plan to promote differentiated drug projects. The company’s Dr. Liu said well planned operations can help a company stand out. By integrating statistics into clinical trial design, a well-calculated sample size and quality data can speed up drug development and improve the rates of success rates. 3DMed integrates biological characteristics, clinical diagnosis/treatment and drug R&D data to discover better candidates.
Traditionally, China's venture capital industry has encouraged young companies to adopt a risk adverse strategy, choosing safer projects rather than more novel ones, said Chen Yu, Vivo Capital’s managing partner. He believes that may be changing now, largely because the Hong Kong and Shanghai stock exchanges are offering avenues to IPO before the companies are profitable. As a result, Dr. Yu says, “We’re likely to see investment concentrate more on better companies with great teams and good science.”