Hutchmed’s very first employee and longtime CEO, Chrisian Hogg, is retiring after a 15-year run, just as the Chinese company is prepping to break into the U.S. market.
As of Friday, Hogg has retired from Hutchmed and handed the baton to another company veteran, Weiguo Su, Ph.D., who has been the chief scientific officer since 2012.
“After over 34 years away and 27 years in China, I have taken the decision to return home to Europe to focus on and be close to my important family responsibilities,” Hogg said in a statement Thursday. The departing CEO has no disagreement with the board, Hutchmed said.
Hogg and Su have built Hutchmed into an industry leader in China’s biotech scene, with triple listings in London, Hong Kong and on the Nasdaq. The company had successful China launches of three self-discovered oncology drugs.
In 2018, Hutchmed’s biotech engine produced its first commercial product as Eli Lilly-partnered Elunate (fruquintinib) snagged a Chinese nod for colorectal cancer patients who had failed at least two treatments. The VEGFR inhibitor marked the first domestically made medicine for a major cancer type in China.
Last year, Hutchmed launched Sulanda (surufatinib) in China for neuroendocrine tumors and AstraZeneca-partnered MET inhibitor Orpathys (savolitinib) for non-small cell lung cancer with MET exon 14 skipping mutations.
Thanks to those three meds, Hutchmed nearly quadrupled its oncology revenues in 2021 to $119.6 million. Over the past three years, the company has built its oncology sales team from scratch to 630 staffers in China as of November 2021, Su said during a press conference Friday.
The CEO transition happens as Hutchmed awaits an FDA decision for surufatinib in pancreatic and extra-pancreatic neuroendocrine tumors (NETs), expected by April 30. In preparation for what would be the company’s first U.S. launch, Hutchmed has gathered 54 U.S. commercial and medical affairs staffers, with a plan to grow to 84 by the time of approval, Su told reporters.
Surufatinib’s FDA application was mainly based on data from two positive phase 3 clinical trials in China, both of which stopped early after the drug showed superior efficacy. It also includes an early-phase bridging study in American patients.
The FDA recently raised serious concerns over the use of China-only clinical data for seeking U.S. oncology approvals in an overwhelmingly negative review of Eli Lilly and Innovent Biologics’ application for PD-1 inhibitor, Tyvyt, for non-small cell lung cancer.
Surufatinib’s situation is different, Su said during the press call. Hutchmed compiled its data package in close consultation with the FDA, he said. The FDA lambasted Lilly and Innovent for their lack of communication with the agency.
What’s more, surufatinib has U.S. data in a group of NET patients that had tried even more prior lines of therapy than Chinese patients had in the phase 3 trials, Su noted, and it showed consistent efficacy, safety and pharmacokinetics data.
In snubbing Tyvyt, the FDA said the drug doesn’t deserve regulatory flexibility because it won’t fill an unmet medical need, given multiple PD-1/L1 inhibitors are already available in NSCLC. By contrast, Su argued surufatinib is offering a better option for some NET patients while filling a treatment void for others.
Existing targeted NET drugs, namely Novartis’ Afinitor and Pfizer’s Sutent, only cover about 70% of NET patients, and their efficacy and safety profiles are less than ideal, Su said. Surufatinib is the only targeted small molecule drug that can cover NETs originated from any organ, he said.
But the clinical profile aside, surufatinib’s FDA decision faces one uncertainty. While the FDA has finished mid- and late-cycle review meetings with Hutchmed, it has yet to complete clinical trial and manufacturing inspections, Su said. The FDA’s inspection activities, especially for foreign missions, have become relatively unpredictable lately because of COVID-19. GC Pharma just got a complete response letter for its immunoglobulin product, because the FDA wasn’t able to inspect a South Korean plant on time.
Besides Sulanda, Hutchmed recently wrapped up enrollment in the global phase 3 FRESCO-2 trial for Elunate in third-line colorectal cancer to support U.S. and EU filings, with data expected in the second half of 2022. As for Orpathys, Hutchmed and AZ plan to launch a global phase 3 clinical trial dubbed SAFFRON in mid-2022. It will combine Orpathys with AZ’s blockbuster Tagrisso in NSCLC patients who have progressed on Tagrisso because of MET amplification.
Su will continue to oversee those R&D efforts as Hutchmed searches for his replacement.