HONG KONG – China has approved its third homegrown PD-1 drug in merely six months, with a nod for camrelizumab, developed by pharma R&D giant Jiangsu Hengrui Medicine Co. Ltd., as a third-line treatment for recurrent or refractory classical Hodgkin's lymphoma.

"After the marketing approval, we should have the product on the market within two months," Lianshan Zhang, president of global research and development at Hengrui, told BioWorld Asia.

Hengrui has been waiting for this approval since 2015, when it invested ¥850 million (US$123 million) in building a biologics manufacturing plant in the Suzhou high tech park designed to handle commercial quantities. (See BioWorld, July 15, 2015.)

A humanized monoclonal antibody recognizing the PD-1 receptor, camrelizumab is the fifth PD-1 agent approved to be sold on the Chinese market, and the third one developed domestically.

Other competitors include Bristol-Myers Squibb Co.'s Opdivo (nivolumab) for previously treated non-small-cell lung cancer, Merck & Co. Inc.'s Keytruda (pembrolizumab) for unresectable or metastatic melanoma, Shanghai Junshi Biosciences Co. Ltd.'s Tuoyi (toripalimab) for metastatic melanoma and Innovent Biologics Inc.'s Tyvyt (sintilimab injection) for recurrent or refractory classical Hodgkin's lymphoma.

After Opdivo and Keytruda were approved in China in June and July 2018, respectively, China has not slowed down in bringing in more PD-1 drugs. In December, regulators gave the regulatory clearance to Tuoyi, then Tyvyt in little more than a week.

Camrelizumab is priced higher than the other two China-made PD-1 drugs. It costs ¥9,900 per 100 mg while Tuoyi and Tyvyt are priced at ¥3,000 and ¥7,838, respectively, for the same dosage. Obviously, Hengrui has no plans to seize the market with a pricing strategy.

Speaking of Tyvyt, which also treats classical Hodgkin's lymphoma, Zhang said it is up to the physicians which drug they will choose and they can compare the data.

Camrelizumab could have competitive pricing once it enters the charity program in China that grants patients greater access to the drug, he noted. "To stand out in an increasingly competitive PD-1 market as China is speeding up approving more innovative biologics, it is important to develop PD-1 drugs for more indications in order to seize more market share," said Zhang.

Currently, there are around 20 clinical trials testing camrelizumab in multiple indications, including lung cancer, liver cancer, gastric cancer, esophageal cancer, nasopharyngeal carcinoma, lymphoma, melanoma and other advanced solid tumors, being conducted in China and Australia and testing the drug both as a monotherapy and in combination with other therapeutic agents.

"After all, the market for classical Hodgkin's lymphoma drugs is small in China. The main field is for indications that see more Chinese patients," Zhang noted. "We need to focus on the China market and target diseases that see mostly Chinese patients. For example, liver cancer and nasopharyngeal carcinoma," he said.

In the PD-1/PD-L1 space, Hengrui is also developing anti-PD-L1 monoclonal antibody SHR-1316 and bispecific antibody SHR-1701, which targets PD-L1 and TGFbetaR2. SHR-1316 is in a phase III study and SHR-1701 is in phase I.

"As a leading player, we eye the global market. We are actively seeking overseas partners to take our products beyond China," said Zhang.

For example, Hengrui has been collaborating with LSK Biopharma Inc. since October 2018 to evaluate the safety and efficacy of the U.S. firm's rivoceranib in combination with camrelizumab for patients with advanced hepatocellular carcinoma.

Growing PD-1/PD-L1 market

According to market intelligence provider Frost & Sullivan, the estimated PD-1/PD-L1 antibody market size in China will grow to ¥98.4 billion by 2030. Combination therapies are expected to be a major growth driver in the future.

In terms of patient volume, it is estimated that homegrown PD-1 and PD-L1 antibodies will account for 70% of the addressable patient population.

On a global scale, the sales revenue from PD-1 and PD-L1 antibodies is expected to continue to rise over the next 10 years, amounting to $78.9 billion in 2030 due to the expansion of new cancer indications and launch of combo therapies.

After Junshi, Innovent and Hengrui, the next one off the mark should be Beigene Ltd., which has developed PD-1 drug tislelizumab to treat patients with previously treated locally advanced or metastatic urothelial carcinoma. Two weeks ago, the firm said the Chinese regulators had accepted a supplemental new drug application for the biologic.

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