BEIJING – Three-year-old Asia-focused startup Everest Medicines Ltd. closed one of the biggest financing rounds in China’s health care market this year, adding $310 million to its war chest. The firm is aiming to advance its late-stage assets in-licensed from global partners to the China market soon.

The series C round included a $260 million series C-2 led by Janchor Partners and a $50 million series C-1 joined by Jiashan SDIC. Everest recently unveiled a strategic partnership with Jiashan SDIC and Jiashan National Economic and Technological Development Zone in March, where it is setting up its GMP/GSP facilities.

“The funds will continue to support our ongoing clinical trials and roll out new programs,” Everest CEO Kerry Blanchard told BioWorld. In a separate statement, he said the financing round reinforces its “strategic business model to in-license global innovation for the development of critical therapies in greater China and Asia,” and supports the building of a foundation for commercial business.

Even after this financial milestone, Everest has yet to unveil any intention to go public at any time soon.

“It’s too early for us to discuss IPOs at this time,” Blanchard said. “The company wants to focus on deploying the funding to drive its various clinical programs and build out its commercialization organization in preparation for future launches, as well as develop other capabilities such as CMC, regulatory affairs, etc.”

As Everest’s incubator, CBC Group has invested a total of $200 million in the company to date, including $50 million this round. Wei Fu, CBC Group’s CEO and Everest’ chairman, explained how the company has achieved so much in such a short period since its inception in late 2017. “By targeting late-stage ‘crown jewel’ assets with proof-of-concept data, Everest is able to minimize risk in drug development, and realize value by quickly advancing into registrational trials in China,” Fu told BioWorld.

Multiple assets nearing registration

Since it was established, the startup has added eight drug candidates to its pipeline that spans a number of underserved areas, such as oncology, infectious diseases, cardiorenal diseases and autoimmune diseases. It said those assets have first-in-class or best-in-class potential, and some are in late clinical stage, only a step away from commercialization.

“Xerava, etrasimod, taniborbactam and ralinepag XR are currently in clinical trials designed for registration in China,” Blanchard said. “Trodelvy and Nefecon will start registrational trials in 2020. If our development plans proceed on schedule, our first NDA filing will be by the end of 2020.”

Xerava (eravacycline) is designed to treat complicated intra-abdominal infections (cIAIs). Everest in-licensed the fully synthetic, broad-spectrum fluorocycline antibiotic from Tetraphase Pharmaceuticals Inc., of Watertown, Mass., in February 2018 to develop and commercialize it in China, Taiwan, Hong Kong, Macau, South Korea and Singapore. The drug has already been approved for treating cIAI in the U.S. and EU, and lately Singapore under Everest’s efforts. The drug is now in a phase III trial in China to support its regulatory approval.

Eravacycline is a novel parenteral antibiotic of the tetracycline class. It has shown broad in vitro activity against gram-negative pathogens that have acquired multidrug resistance and are prevalent in China.

Meanwhile, etrasimod is a potential best-in-class oral modulator of the sphingosine 1-phosphate receptor that is in a multicenter phase III trial in ulcerative colitis in China, South Korea and Taiwan. It was in-licensed from Arena Pharmaceuticals Inc. in December 2017.

Ralinepag XR is a potential best-in-class extended-release agonist of the IP receptor that allows convenient oral dosing for treating pulmonary arterial hypertension. It is in a global phase III trial in collaboration with its licensing partner, United Therapeutics Corp.

Last but not least is taniborbactam, a parenteral, potential best-in-class, cyclic boronate compound that inhibits serine and metallo-beta-lactamases. Everest licensed the drug candidate from Venatorx Pharmaceuticals Inc. Both companies are now conducting a global phase III trial for patients with complicated urinary tract infections.

After receiving the funds, Everest will also go ahead with the registrational trials for Trodelvy (sacituzumab govitecan) and Nefecon, a modified-release oral formulation of corticosteroid budesonide, this year, Blanchard said.

Trodelvy is a first-in-class anti-Trop-2 antibody-drug conjugate for metastatic triple-negative breast cancer. It has won FDA approval for treating patients with this indication who have received at least two prior therapies. In China, Everest received trial approval for the drug candidate for the same indication in April, and it plans to begin clinical trials in multiple solid tumor indications.

Meanwhile, Nefecon is a potential first-in-disease product for treating IgA nephropathy. Everest received the trial approval last December, and is going to join the global phase III trial co-conducted with its licensing partner Calliditas Therapeutics Inc.

Two other assets that Blanchard had not mentioned are FGF-401 and SPR-206.

FGF-401 is an ATP-competitive, reversible-covalent inhibitor of FGFR4 that Everest in-licensed from Novartis AG. In March, Everest obtained trial approval in China to initiate a phase Ib/II study in patients with hepatocellular carcinoma. Meanwhile, SPR-206 is a novel polymyxin derivative designed to reduce the kidney toxicity that is seen clinically with polymyxin B and colistin. No clinical plans for SPR-206 have been made public yet.

No Comments