Shanghai Green Valley Pharmaceutical Co., Ltd.

The ballooning controversy around Biogen and its Alzheimer’s drug isn’t deterring others from the gold rush — and the search is global. China’s Simcere is licensing regional rights to a Phase IIb anti-amyloid drug from German biotech Vivoryon Therapeutics and taking the lead on clinical development locally. All told, the pact is valued at up to $565 million, including an undisclosed upfront payment. The small molecule candidate, varoglutamstat, targets a subtype of amyloid known as N3pE or pGlu-Abeta. Notably, China had stunned the world with a surprise Alzheimer’s approval back in 2019, when Shanghai Green Valley Pharma landed a conditional OK for its seaweed-derived therapy. The tablets have been available on the market for months while the company is setting up a confirmatory Phase III study in the US. That was a time when skeptics had a louder voice about whether clearing beta amyloid could indeed have an effect on the memory-wasting disease. Instead of offering a definitive answer, Green Valley had noted that amyloid was just one of many targets its molecule could engage. None of those criticisms went away, to be sure; if anything, they protested louder. But at least drugmakers now know that the amyloid theory had a friend at the FDA, where regulators were willing to look at the bright side of mixed results and designate amyloid reduction as a surrogate endpoint. Days ago, regulators doubled down by issuing breakthrough therapy designation to two other amyloid drugs, including one that Eli Lilly plans to submit for approval within months. Ulrich Dauer “Along with inspiring hope for patients, families and caregivers, the FDA’s decision demonstrates that there is progress being made in the AD field to wider audiences, including scientists and drug developers working on novel therapeutics and also investors who contribute to these efforts,” Ulrich Dauer, CEO of Vivoryon, told Labiotech.eu earlier this month. An established pharma powerhouse in China that Bristol Myers Squibb and Amgen have entrusted with their own drugs over the years, Simcere will be leveraging its clinical, commercial and manufacturing know-how to push varoglutamstat for early Alzheimer’s. The data they generate are also expected to complement Vivoryon’s own trials in Europe (ongoing) and the US (to begin later this year). On top of the lead program, Simcere has also bagged an option on a preclinical antibody that similarly targets N3pE amyloid. Social image: Ren Jinsheng, Simcere CEO