Biogen and partner Eisai's aducanumab have won a landmark—yet widely criticized—FDA approval for Alzheimer's disease drug Aduhelm, and the companies are eying a big potential market in Asia. China's Stemirna Therapeutics raised $188 million for its mRNA COVID-19 vaccine ambitions. Chinese authorities have cleared a homegrown HER2-targeted antibody-drug conjugate by RemeGen for stomach cancer. And more.
In a controversial move, the FDA went against its external advisers' recommendations and approved Biogen’s Eisai-partnered Alzheimer’s drug aducanumab, now marketed as Aduhelm. The biomarker-driven conditional go-ahead covers all Alzheimer’s patients even though the drug was only tested in early-stage patients who harbor beta amyloid plaques. Because of the broad label and an estimated $56,000 annual list price, analysts project it could be one of the biggest launches in biopharma history.
Meanwhile, Eisai CEO Haruo Naito sees a “considerable blockbuster” opportunity for the drug in Asia. The large patient population in China, Japan and elsewhere represents an “enormous” market that could contribute considerably to Eisai’s revenues, he said in an interview with Nikkei. Biogen filed aducanumab with Japanese authorities in December.
As BioNTech and Modern have validated their mRNA tech with successful COVID-19 vaccines, China’s Stemirna Therapeutics hopes it can join the fray and has raised CNY 1.2 billion ($188 million) to bankroll its pandemic mRNA candidate. Sequoia Capital China, state-backed China Merchants Medical and Healthcare Industry Equity Fund co-led the round.
3. China clears first homemade ADC, a HER2 med by RemeGen (release, PDF)
Less than a year after its $515 million Hong Kong IPO, China’s RemeGen has ushered its second product across the regulatory finish line. The biotech’s disitamab vedotin, an anti-HER2 therapy, has become the first homegrown antibody-drug conjugate to be approved in China. The current conditional nod is for HER2-positive stomach cancer after at least two prior systemic therapies. In a phase 2 trial, the drug triggered a response in 24.4% of third- or later-line stomach cancer patients. It bears an FDA breakthrough-therapy designation for second-line treatment of HER2-postive bladder cancer.
Astellas’ Xtandi has won backing from England’s National Institute for Health and Care Excellence to treat patients to treat patients with metastatic hormone-sensitive prostate cancer. The decision puts Xtandi ahead its rival Erleada from Johnson & Johnson, which was rejected by the drug cost watchdog at the end of May.
A slate of South Korean investors has led U.K. biotech Iksuda Therapeutics’ $47 million financing round. They are: Celltrion, Mirae Asset Capital and Premier Partners. The money will go toward the company’s antibody-drug conjugates, including efforts to move its lead preclinical candidate, IKS03, a CD19-targeted ADC, into phase 1 clinical trials.