GlaxoSmithKline's fast-growing Shingrix has nabbed approval in China after its drug regulator put the shot on its list of high-priority new products. Roche's Chugai is investing $1.15 billion to combine two Japanese R&D sites into a new one. Eli Lilly's breast cancer therapy Verzenio, a key driver for the company's oncology ambitions, was slapped with a safety warning in Japan. And more.
Riding on explosive growth in the U.S., GlaxoSmithKline’s shingles vaccine, Shingrix, has now won conditional approval in China. The company will launch the shot in phases beginning in 2020 as it ramps up manufacturing capacity. Meanwhile, China’s drug authority ordered GSK to conduct follow-up studies to better illustrate its China-specific profile and explore whether the novel adjuvant could increase the risk of immune disorders.
Roche’s Chugai will invest 127.3 billion yen ($1.15 billion) on a new R&D site in Yokohama to combine two labs it now operates in Gotemba and Kamakura. Chugai expects to have the site up and running in January 2023. The news comes as Chugai prepares to chase Alexion’s Soliris and file its IL-6-targeting antibody satralizumab for FDA approval in neuromyelitis optica spectrum disorders.
Amid its global retreat with Lartruvo, Eli Lilly’s oncology ambitions have taken another blow. Breast cancer therapy Verzenio, which was counted as a key growth driver in the first quarter, is suspected to have caused serious lung disease in several patients, including one who died. Lilly has updated the drug’s label in Japan and said the incidence is higher in the East Asian population.
WuXi Biologics says its joint venture WuXi Vaccines will build a dedicated facility to manufacture a commercial vaccine product in a contract that should produce $150 million a year for 20 years. Though it didn’t identify the client, it did say the site will make 100% of that vaccine’s global supply.
Takeda launched a new biotech with Frazier Healthcare. Phathom Pharmaceuticals will take its late-stage gastrointestinal drug vonoprazan toward the finish line. Designed to treat stomach acid reflux, the drug is approved in several Asian markets but not yet OK’d in Europe or the U.S. Phathom will be working with a $90 million funding round and a $50 million credit line.
Two Japanese companies are reportedly looking at selloffs. Brazil’s EMS Pharma is the front-runner to make a formal proposal for Takeda’s Latin American business, which could fetch $1 billion, Reuters reported. Meanwhile, Daiichi Sankyo is in talks with several companies to sell its over-the-counter business, which could be worth $910 million, Reuters said, quoting Nikkei Business. However, Daiichi said the deal news was “not correct.”
Less than a year after Samsung said biopharma would be a key target in its $22 billion expansion plan, Celltrion Chairman Seo Jung-jin made a similar pledge. Celltrion will spend about $33.6 billion on its pharma business over the next decade, focusing on biologics, active ingredients and artificial intelligence, the Korea Herald reported.
Mitsubishi Tanabe’s American operations, which produce the amyotrophic lateral sclerosis treatment Radicava, have created an open database to help patients find healthcare and infusion centers. Dubbed the ALS Care Locator, the platform currently has about 700 providers, and the firm expects the number will become “several times larger” in the coming months.
Daiichi Sankyo missed the deadline to manufacture enough bird flu vaccine for Japan in case of an epidemic. Instead of the promised doses to vaccinate 40 million people, it is only able to supply enough for 23 million. As a penalty, the company is returning part of the government grant and will pay a delinquency charge, it said.