HONG KONG – Shanghai Haihe Biopharma Co. Ltd. has completed a series B financing, raising $144.6 million. Added to a prior round that secured about $50 million, Eric He, chief business officer at Haihe, told BioWorld Asia, the firm plans to use the funds to move forward its 10 clinical assets and five preclinical candidates for antineoplastic and metabolic diseases.

"Six of the clinical assets are after the proof-of-concept stage," said He. "They came from in-house discovery programs or licensed-in programs to address the unmet needs in China, Asia and the world." Nine out of the 15 drug candidates were discovered in-house.

Nine investors, including Huagai Capital, CSPC Pharmaceutical Group Ltd., Chinese Academy of Sciences Venture Capital Management, Daehwa Pharmaceutical Co. Ltd. and others participated in this round of financing.

The firm's lead asset is RMX-3001, an oral paclitaxel formulation and a microtubule-stabilizing agent. It won marketing approval to treat gastric cancer in Korea under the trade name Liporaxel as the world's first successfully developed oral paclitaxel. Haihe in-licensed it from Daehwa, and the drug is now in phase III study in China for treating gastric and breast cancers.

Last October, Haihe obtained IND approval from Chinese regulators to put RMX-3001 in an international multicenter phase III trial as first-line treatment of recurrent or metastatic breast cancer compared with Taxol (paclitaxel injection, Bristol-Myers Squibb Co.).

Haihe said it took only four months to obtain the IND approval for gastric cancer for RMX-3001; then only three months for this one.

Another drug candidate is plant extract ON-101. It is now in phase III trial in China and the U.S. to treat diabetic foot ulcers.

In phase II testing in China are AL-3810 (lucitanib) and simmitecan, which are developed to treat thymic cancer and colorectal cancer, respectively.

The in-house-developed AL-3810 is an oral small-molecule tyrosine kinase inhibitor targeting FGFR1/2, VEGFR1-3, PDGFR α/β, and it has the potential to be combined with PD-1/L1 antibodies. Haihe said it features rapid oral absorption and it has shown a better safety profile compared to other competitors. It is now in a phase II trial in 16 sites in China.

Simmitecan is a second-generation topoisomerase I inhibitor for which Haihe owns exclusive global rights. The firm said no severe diarrhea was observed and it is less toxic compared to irinotecan in studies for multiple advanced solid tumors.

Another asset to note is SCC-244 (glumetinib), a c-Met inhibitor treating advanced solid tumors that is now in two phase I trials in China. It is discovered and developed by Haihe, which owns the global rights. Other assets in early clinical stage include a PI3Kα inhibitor, CYH-33; a new generation COX-2 inhibitor, RMX-1001; a first-in-class EP4 receptor antagonist, RMX-1002; a new antibiotic, RMX-2001; and FGFR1-3 inhibitor, dubbed HH-185.

Haihe said it obtained the IND approvals for AL-3810, CYH-33, HH-185 and RMX-2001 all in 2018.

In 2018 Haihe out-licensed to 3D Medicines Inc. the rights to develop, manufacture and commercialize HH-185 in the Chinese mainland, Hong Kong, Macau and Taiwan. The drug has the potential to be used with PD-1/L1 antibodies.

"We have long kept an eye on Haihe. During the past year, Haihe has received more than 10 IND approvals and made breakthroughs in discovering oncology targets and in its clinical work," said Zhiqiang Zeng, partner at Huagai Capital, which led this financing round for Haihe.

Haihe is run by veteran biopharma experts. Its CEO Ruiping Dong served at different global pharma giants. He was the global senior vice-president and emerging market R&D president at Merck Sharp & Dohme, global vice-president and president of R&D for Japan and China of Bristol-Myers Squibb, as well as medical director of oncology clinical research at Astrazeneca plc.

He returned to China under the country's recruitment of global experts program known as "The Thousand-Talent Plan" to found RMX (Shanghai) Pharmaceutical Technology Co. Ltd.

In March 2018, Dong's RMX Biopharma merged with Shanghai Haihe Pharmaceutical Co. Ltd.

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