Yuhan, Luoxin Deal Underscores Asian NSCLC Therapy Needs
Executive Summary
Yuhan and Luoxin's licensing agreement for a third generation EGFR inhibitor, the second such deal between South Korea and China, suggests robust demand for novel drugs for non-small cell lung cancer in Asia.
Yuhan Corp., a leading South Korean pharma group, has inked a licensing out agreement with Luoxin Biotechnology Co. Ltd. which will grant the Chinese firm exclusive rights to develop, seek regulatory approval, produce and commercialize a novel EGFR inhibitor, YH25448, for non-small cell lung cancer (NSCLC) in China, Hong Kong and Macau.
The deal marks the first big licensing out move in recent years for Yuhan, which has been stepping up its open innovation drive, while Luoxin becomes the second Chinese firm to acquire selected rights to a South Korea-originated, third generation EGFR inhibitor following ZAI Lab Ltd., which reached a licensing agreement with Hanmi Pharmaceutical Co. Ltd. last year.
Under the new agreement, Yuhan will receive a total of $120m in stages as well as sales royalties. The two companies will jointly pursue clinical development of YH25448 in South Korea, China and Taiwan with a goal of receiving IND approvals from these countries this year, said Yuhan.
YH25448 is a still preclinical stage molecule that Yuhan licensed in from South Korean bioventures Oscotec in July last year for KRW1.5bn ($1.34m). Yuhan is slated to conduct up to Phase II clinical development at home and abroad.
The drug is said to be effective in EGFR-mutated NSCLC resistant to existing EGFR inhibitors such as AstraZeneca PLC's Iressa (gefitinib) and Genentech Inc.'s Tarceva (erlotinib), and also has high potential in brain metastatic NSCLC which lacks effective treatments at present, Yuhan said.
Lung cancer is the most prevalent malignancy in males in China and also the most deadly form of cancer overall in the country.
Demand, Competition
The deal indicates robust demand for novel drugs to treat NSCLC in Asian countries although these markets are expected to see strong competition given that a number of new EGFR inhibitors are under development, with some of these already launched in some regional markets such as South Korea and Japan.
According to Datamonitor Healthcare analyst Hardik Patel, EGFR mutation occurs more commonly in Asian NSCLC patients (about 40% of whom have EGFR mutations) than it does in western populations (about 15%). The T790M mutation, which most third-generation EGFR inhibitors are targeting, is a secondary mutation that occurs in up to 60% of EGFR mutation-positive patients.
Yuhan estimates the Chinese market for its drug to reach about $1.4bn in 2019, while the number of NSCLC patients in the country is seen reaching about 690,000 in 2022. "We expect to seek separate deals for Europe and the US," said Yuhan, without elaborating.
But YH25448 isn't the only new EGFR inhibitor being developed in China and South Korea. Last year, Hanmi and ZAI Lab reached a collaboration and license agreement under which the Chinese company will acquire exclusive rights in China, Hong Kong and Macau to develop, manufacture and commercialize HM61713 (olmutinib), Hanmi’s drug for EGFR mutation-positive lung cancer (Also see "Hanmi’s Roll Continues With ZAI China Cancer Deal" - Scrip, 23 Nov, 2015.).
Olmutinib is an irreversible EGFR mutant-selective tyrosine kinase inhibitor (TKI) developed to specifically target tumors with T790M mutations, and was recently launched as Olita in South Korea, its first market worldwide.
Also in 2015, Hanmi licensed out the global development and commercialization rights, excluding South Korea, China, Hong Kong and Macau, for another third generation EGFR inhibitor, HM61713 (BI1482694), to Boehringer Ingelheim GMBH.
Both YH25448 and olmutinib will also have to compete with AstraZeneca's newly launched EGFR inhibitor Tagrisso (osimertinib), although another potential rival, Clovis Oncology Inc.'s rociletinib, left the field in May in anticipation of a US FDA approval rejection (Also see "Clovis Pulls Plug On Rociletinib On Expected FDA Rejection" - Scrip, 5 May, 2016.).
Tagrisso has recently debuted in South Korea, which is its fifth market after the US, Europe, Japan and Israel (Also see "Korean Tagrisso Launch Builds On Extensive Local Data" - Scrip, 23 Jun, 2016.).
Open Innovation, Deals
Yuhan said the Luoxin deal, its biggest so far, is seen as a successful example of its open innovation strategy, which has already included actively engaging with bioventures.
In March, Yuhan and San Diego-based clinical stage firm Sorrento Therapeutics Inc. agreed to set up a new joint venture, ImmuneOncia Therapeutics LLC., to develop and commercialize a number of the US venture’s immune checkpoint antibodies against undisclosed targets, for both hematological malignancies and solid tumors (Also see "Yuhan Joins Immuno-Oncology Wave Via Sorrento JV" - Scrip, 3 Mar, 2016.).
Late last year, Yuhan then agreed to invest KRW20bn in Genexine Inc. as part of a strategic collaboration that aims to develop novel drugs combining Genexine's proprietary platform technology to generate long-acting protein therapeutics (hyFc) and Yuhan's innovative drug pipeline.
Yuhan also owns stakes in various other biotechs including Theragen Etex Co. Ltd., Bioneer and PharmAbcine Inc. and analysts expect the company to reach additional licensing out agreements this year.
NH Investment & Securities expects Yuhan to unveil results from a Phase IIb clinical trial of YH14618, a degenerative disc disease therapy it has licensed in from Ensol Biosciences Inc., and reach a licensing out deal with a multinational pharma in the second half of this year.
From the editors of PharmAsia News.