HONG KONG – Hong Kong-headquartered Hutchison China Meditech Ltd.’s (Chi-Med) NDA for surufatinib as a treatment for patients with advanced non-pancreatic neuroendocrine tumors(NET) has been accepted for review by China’s National Medical Products Administration (NMPA).

The NDA is supported by data from Chi-Med’s successful phase III study on the use of surufatinib on patients in China with advanced NET-extra pancreatic, for whom there is no effective therapy.

“We believe surufatinib has robust efficacy, tolerability and combinability with a dual angio-immuno kinase inhibition profile, which may make it an attractive treatment in China,” said Christian Hogg, Chi-Med CEO.

Hogg added that the company is building its own dedicated commercial oncology organization and expects to be ready to cover all relevant hospitals and clinics in China at the time of launch, which was not revealed.

Chi-Med holds the worldwide rights to surufatinib. The drug is under investigation for use against multiple solid tumors in China, the U.S. and Europe, both as a monotherapy and in combination with immunotherapies. Amongst ongoing trials is a phase IIb/III study testing the drug against capecitabine in biliary tract cancer in China.

There is also a phase III study in pancreatic neuroendocrine tumors ongoing in China. It is subject to an interim analysis in the first half of 2020. If successful, Chi-Med said surufatinib would benefit the broadest group of NET patients, as other NET drugs are only studied in select patients.

This is Chi-Med’s second NDA filing in China, which previously submitted and received approval for Eluate (fruquintinib) for third-line colorectal cancer in China. It was launched in November 2018. “In addition to being the marketing authorization holder, we manufacture and supply fruquintinib to our partner Eli Lilly, who is responsible for commercialization,” a spokesman for Chi-Med told BioWorld.

In the first half of 2020, we plan to initiate registration-enabling studies for surufatinib in neuroendocrine tumors and fruquintinib in late-stage colorectal cancers in the United States. As these two drugs have demonstrated to be effective and differentiated in randomized controlled studies in similar (not identical) settings in China, we believe these programs are de-risked,” he added.

Unlike with fruquintinib, Chi-Med plans to commercialize surufatinib using its own commercial organization, which covers more than 24,400 hospitals in over 330 cities and towns in China.

Building a commercial team

Chi-Med is a company under Hong Kong conglomerate CK Hutchison Holdings Ltd. Its prescription drug joint venture, Shanghai Hutchison Pharmaceuticals Ltd., commercializes a number of household brands such as Shexiang Baoxin Pill, a nationally known oral vasodilator and pro-angiogenesis drug.

Chi-Med intends to tap into the business know-how and funds gained from that business to support the commercialization of surufatinib and future innovative medicines to come.

“Our commercial platform is built over nearly two decades and consists of several joint ventures, some of which are consolidated fully into the financials, while for the others we record our share of the income only. In total, these entities generated $664 million in sales during 2018,” said the spokesman. “Since formation to 2018, our share of net profits from these JVs was approximately $300 million. Cash generated from this business is being used to support the R&D of innovative medicines such as fruquintinib, surufatinib and savolitinib.”

Chi-Med already has certain medical affairs and commercial team members in place. It will continue to build out its oncology sales, marketing and medical affairs organization in the next 12 months, and aims to have full China coverage by the time surufatinib is approved.

Another key driver of Chi-Med’s pipeline is its global collaboration with Astrazeneca plc for savolitinib, a MET inhibitor.

“MET is an important driver in non-small-cell lung cancer, both as a monotherapy (when the tumor has MET exon 14 deletion) and in combination with EGFR inhibitors (when the tumor has MET amplification),” said Chi-Med’s spokesman. “It has been observed that up to 30 percent of Tagrisso-resistant non-small-cell lung cancer patients need a MET inhibitor.

“We have completed recruitment of the MET exon 14 deletion study in China, and await data readout. If positive, we could file another NDA in China in the first half of 2020.”

Chi-Med also has an ongoing phase III study with fruquintinib and paclitaxel in second-line gastric cancer in China, where gastric cancer is highly prevalent. It stated that a second interim analysis is possible in the first half of 2020.

Chi-Med has also seen promising data in fruquintinib combined with Iressa (gefitinib) in non-small-cell lung cancer that has MET amplification and is positive for certain EGFR mutations.

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