First patient treated with Optune® providing new therapeutic option for an urgent and unmet clinical need
Second product commercialized by Zai Lab in Hong Kong
HONG KONG, Dec. 28, 2018 (GLOBE NEWSWIRE) — Zai Lab (NASDAQ: ZLAB) today announced the launch of Optune® (Tumor Treating Fields or TTFields) in Hong Kong for the treatment of glioblastoma multiforme (GBM) with the treatment of its first patient. Hong Kong is the fourth market after the United States, Europe and Japan to have access to this important new medical technology. Optune is the second product, along with the PARP inhibitor ZEJULA® (niraparib) for the treatment of ovarian cancer, commercialized by Zai Lab in an Asian market.
Optune is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing affected cancer cells to die. Zai in-licensed the technology from Novocure in September 2018. Novocure markets Optune in the U.S., Europe, Japan and certain other countries for the treatment of GBM and is in advanced clinical development for multiple solid tumor indications. While Optune is not yet approved for commercialization in China, the technology was included and recommended with Level 1 evidence as a treatment for GBM in China’s Glioma Treatment Guideline published in 2016. In December 2018, the national treatment guideline was expanded to include both newly diagnosed and recurrent GBM patients.
Temozolomide (TMZ) is the only therapeutic approved in China for the treatment of newly-diagnosed GBM. Optune will be the second approved therapy. In the pivotal trial conducted by Novocure that was the basis for the product’s regulatory approvals, treatment with Optune in combination with TMZ compared to TMZ alone resulted in a more than doubling of the five-year overall survival (OS) rate. Optune demonstrates a profound compliance response in which median OS increases with the percentage of monthly time using Optune.
“Since our initial launch of ZEJULA in Hong Kong we have been building our commercial infrastructure in preparation of launching Optune into that market,” said William Liang, Chief Commercial Officer of Zai Lab. “We have been working with Novocure to incorporate their operational best practices into our commercial procedures. Successfully launching two products in Hong Kong will also provide us with valuable experience as we prepare to do the same in the larger China market.”
Dr. Samantha Du, founder and CEO of Zai Lab said, “The launch of Optune in Hong Kong to help GBM patients continues our commercialization momentum that started with the approval and launch of ZEJULA in Hong Kong and the recently-announced China National Medical Product Administration’s acceptance of our NDA submission of niraparib as a Category 1 drug for the maintenance treatment of adults recurrent epithelial ovarian, fallopian tube or primary peritoneal ovarian cancer. 2019 is emerging as a transformational year for the company as we continue our commercial progress in Hong Kong, prepare for commercialization in China and continue to grow and advance our differentiated pipeline.”
About Tumor Treating Fields (Optune®)
Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.
About Zai Lab
Zai Lab (NASDAQ: ZLAB) is a Shanghai-based innovative biopharmaceutical company focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab’s experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates targeting the fast-growing segments of China’s pharmaceutical market and addressing unmet medical needs. Zai Lab’s vision is to become a fully integrated biopharmaceutical company, R&D, manufacturing and commercializing its partners’ and its own products in order to impact human health worldwide.
ZAI LAB CONTACTS:
Billy Cho, CFO
+86 137 6151 2501
billy.cho@zailaboratory.com
Media: Nancie Steinberg / Robert Flamm, Ph.D.
Burns McClellan, on behalf of Zai Lab
212-213-0006
nsteinberg@burnsmc.com / rflamm@burnsmc.com
Investors: Jill Steier
Burns McClellan, on behalf of Zai Lab
212-213-0006
jsteier@burnsmc.com
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