BeiGene Unveils New Cancer Drug Plant With Eye On Affordability
Executive Summary
A pure drug developer just a year ago, BeiGene has transformed itself into a full-fledged drug maker with its own R&D, manufacturing and commercial operations. But the Nasdaq-listed biotech is looking well beyond speed, including towards a thrust on quality, as it unveils a production site in Suzhou.
As BeiGene opens its first manufacturing site in Suzhou, the city is soon expected to have an additional aspect to showcase: Made-in-China innovative anticancer drugs.
The transformation of Suzhou, which over 1,000 startups call home, reflects what China's drug-making sector has grown to be - more innovative and driven by homegrown startups - noted BeiGene founder Wang Xiaodong in a ceremony held in Suzhou, Nov.8.
That has added to the string of successes so far in 2017 for the Beijing biotech. In March, the China FDA granted a pivotal Phase II clinical trial approval for its BTK inhibitor, BGB-31111, and in May, it signed a partnership with Celgene, worth up to $1bn, for the PD-1 checkpoint inhibitor BGB-A317, the biggest such transaction ever for a Chinese biotech company (Also see "Interview: Beigene Bursts Onto World IO Scene With Celgene Onboard" - Scrip, 13 Jul, 2017.).
BeiGene obtained the Suzhou government’s approval for the five-storey Suzhou site in 2015 and construction license last July. By July 2017, the company had staff ready and all manufacturing equipment in place. During the opening ceremony, BeiGene Suzhou interim general manager Wang Zhiwei announced the commencement of mass production.
Designed in compliance with China, EU and US good manufacturing practice (GMP) standards, the site is located inside Suzhou Sangtiandao biotech park with 11,342 square meters in usable area and entails an investment of roughly CNY200m in equipment.
Made In China BTK Inhibitor
The site will manufacture two of BeiGene’s small-molecular anticancer drugs: BTK inhibitor BGB-3111 and the PARP inhibitor, BGB-290. The design capacity is 50m-100m capsules per annum - sufficient for 20,000 to 50,000 patients.
BGB-3111, the second BTK inhibitor after Abbvie's Imbruvica(ibrutinib), has been studied for chronical B-cell lymphoma and other C-cell hematology cancers. In 2016, the FDA granted BGB-290 orphan disease designation and a pivotal Phase II study is ongoing in China. Meanwhile, studies for a combination with an anti-CD20 antibody, Roche's Gazyva (obinutuzumab), are also ongoing.
BeiGene hopes a lower adverse event occurrence and longer target inhibition will give its BTK inhibitor an edge. A new drug approval application filing to the China FDA is planned for 2018, says the company.
BGB-290, however, is in a more crowded space with several approved PARP inhibitors, including AstraZeneca's Lympaza (olaparib), Tesaro's Zejule(niraparib), Clovis Oncology's rucaparib.
A Phase I dose increasing study of BeiGene’s PARP inhibitor for ovarian, breast and pancreatic cancer is ongoing in Austria, and a Phase I trial in China for solid tumors is enrolling patients. Meanwhile, BeiGene has also initiated a study combining BGB-290 with its immune-oncology candidate BGB-A317
In addition to small-molecule production, the Suzhou factory has one floor assigned to monoclonal antibody production, albeit with a smaller 500L capacity. A much larger biologics manufacturing site is under construction in Guangzhou in Southern China.
Quality And Affordability
As BeiGene prepares for the overseas approval and market launch of the made-in-China cancer drugs, top executives underscore the importance of quality.
An emphasis on quality is also the goal of the China FDA's year-long campaign to ensure clinical data integrity and GMP compliance. Throughout 2016, several major events including the detection of a nationwide vaccine scandal and several rounds of clinical data audits for new drug applicants indicate that the agency does not intend to relent on quality scrutiny.
BeiGene sees quality as its core strength, despite the drug developer getting into manufacturing for the first time. "Quality is part of our culture and DNA," BeiGene founder and CEO John V.Oyler told Scrip during an interview on the sidelines of the opening ceremony. "We are committed to quality," he stressed.
A team led by executives with years of manufacturing experience in biologics at Merck and others also bolsters BeiGene’s confidence.
Besides quality, affordability is also high on the executive's mind. He noted that pricing cancer drugs the same way as in the US is simply “undoable” in China, a country that spends less than 6% of its GDP on healthcare, compared with 16% in the U.S.
Local manufacturing is expected to bring down the cost, although Oyler didn't disclose details around the pricing strategy of the anticancer BTK inhibitor that is nearing regulatory approval.
China has a much bigger population and larger patient base with a high incidence of cancer, noted the BeiGene CEO, and prices should be made affordable and offer reasonable returns, he added.
Not Rushing On Combo Therapy
BeiGene is also looking at deep collaboration in China, including market access and reimbursement.
One of the candidates in focus is BeiGene's immune-oncology asset BGB-A317, which is in a Phase I study in China.
Given its huge potential for multiple cancer indications, immune-oncology has become a crowded space with over 50 companies developing PD-1 or PD-L1 inhibitors. Front-runners include Taizhou Junshi Pharmaceutical,3DMed and AlphaMab, which have also obtained China FDA clinical trial approvals for their PD-1 and PD-L1 asset.
Asked about BeiGene's strategy around combining BGB-A-317 with other drugs, Oyler said the plan is to move in a measured way in China.
"It's still early days for combinations, and people keep asking, does this work?. It's good to have a PD-1 in the game, and a lot of studies need to be done," said the executive.
"However, it's hard and risky, and it needs deep science. We have a clinical team and high-quality manufacturing that gives us confidence."
"We are not rushing it."
From the Editors of PharmAsia News