HONG KONG – After inking a recent deal with China’s Jiangsu Hengrui Medicine Co. Ltd., South Korea’s Crystalgenomics Inc. is celebrating its 20th anniversary by seeking more partners to further develop its anti-PD-1 inhibitor pipeline.
Sebin Jung, Crystalgenomics’ deputy investor and public relations manager, told BioWorld the company would continue to use “various methods, such as mergers and acquisitions as well as agreements, to take ourselves to the next level in our development.”
She said that “rather than start from scratch to research and develop our own PD-1 inhibitor to catch up with other PD-1 inhibitor developers, which could be described as an infinite challenge, we sought to partner with a PD-1 inhibitor that was already market-tested and thus guaranteed in terms of safety.”
Crystalgenomics’ first license agreement, disclosed with Hengrui on April 20, will focus on developing, seeking regulatory approval for and commercializing camrelizumab, a PD-1 inhibitor, in South Korea. The company will pay up to $87.75 million in up-front and milestone payments, as well as royalties of 10% to 12% based on net sales of the product.
The agreement was signed with favorable terms for Crystalgenomics. Korea was one of the sites where global clinical trials were conducted, so Crystalgenomics was able to benefit from the data without incurring the cost of clinical trials. It can also start selling the drug to patients in Korea in the near future.
Another favorable aspect for Korean patients is the cost. Camrelizumab’s market price in China is currently half the cost of other available inhibitors such as Opdivo (nivolumab, Bristol Myers Squibb Co.) and Keytruda (pembrolizumab, Merck & Co. Inc.).
Jung explained that Crystalgenomics and Hengrui built the relationship in a little over a year, as representatives met each other frequently at industry conferences. The last stage of the agreement negotiations were done over the phone and via email, as the COVID-19 pandemic prevented overseas travel and in-person meetings.
Sidley Austin LLP partners Thomas Duley and Ruchun Ji advised Hengrui on the deal.
Duley told BioWorld that he was seeing a “significant increase in innovative science in China,” that is leading to “an increase in cross-border deals and transactions.”
“As companies try to make PD-1 inhibitors more effective for more patients, they combine PD-1 with other therapies in a ‘hub-and-spokes’ model with the hub being the PD-1 inhibitor and the spokes alternate therapies,” Duley added.
Crystalgenomics’ Jung agreed, describing the “marriage” between PD-1 inhibitors and alternate therapies. “It is possible to administer one or the other [either the PD-1 inhibitor or alternate therapies] to the patient, but the two together produce a synergy in their treatment,” she said.
Sidley Austin’s Ji added that “the area is very active,” noting a big trend he has seen is Chinese pharmaceutical companies doing license agreements with overseas companies, and particularly those in Europe and the U.S.
When asked whether Sidley Austin was working on similar licensing deals, Duley and Ji commented that there were “certainly other deals we are engaged with in the same category.”
HDAC inhibitor advancing
Hengrui researches, develops, manufactures and sells a range of health care products, including antineoplastic drugs, angiomyocardiac drugs, drugs for surgery, contrast agents and antibiotics.
“This agreement helps expand the overseas market of camrelizumab, provide a quality treatment option to South Korean patients, and further enhance the company’s brand and overseas performance,” the Chinese company said in a stock market notice. “In the future, the company will continue to pursue its strategy to go global, and accelerate overseas R&D and market expansion with more partnerships.”
Meanwhile, for Crystalgenomics, work is focused on its histone deacetylase inhibitor, CG-745 (ivaltinostat). The company tentatively aims to present the results from its phase II trials in pancreatic cancer patients at the ESMO World Congress of Gastrointestinal Cancer in July 2020. The drug is intended to start phase III trials, and there is an application for a conditional sales license lodged with Korea’s Ministry of Food and Drug Safety, which should enable Crystalgenomics to start selling the product in Korea alongside the phase III trials.
The U.S. FDA granted CG-745 orphan drug designation in late August 2019.
Crystalgenomics, based in Seongnam, also has a U.S. presence under the CG Pharmaceuticals name in Emeryville, Calif. It focuses on structural chemoproteomics-based drug discovery and development. In August, the firm signed a memorandum of understanding for a strategic partnership with Switzerland’s Bellevue Asset Management AG.
Crystalgenomics’ stock climbed to ₩16,150 (US$13.216) after the deal was announced last month, with shares falling 0.39% on May 6 to close at ₩12,800.