Green Val­ley Phar­ma, the Shang­hai drug­mak­er that scored a stun­ning ap­proval to mar­ket an Alzheimer’s drug in Chi­na two years ago, has shut­tered a Phase III tri­al that would’ve paved its way to the FDA.

A lack of fund­ing had forced its hand, ac­cord­ing to the biotech, which said its com­mer­cial sales had with­ered amid a new Covid-19 out­break in Chi­na. It tried to raise ad­di­tion­al fi­nanc­ing but was un­able to due to “geopo­lit­i­cal cir­cum­stances and a chilly cap­i­tal mar­ket for bio­med­ical in­vest­ments.”

The com­pa­ny is­sued a press re­lease ex­plain­ing the ear­ly ter­mi­na­tion in Chi­nese last Fri­day, a few days af­ter End­points News first re­port­ed that the tri­al had been halt­ed, cit­ing tri­al sites.

Er­ic Reiman, a for­mer sci­en­tif­ic ad­vi­sor to Green Val­ley, told End­points he was in­formed the tri­al was dis­con­tin­ued “due to un­ex­pect­ed fi­nan­cial chal­lenges re­lat­ed to the Covid-19 pan­dem­ic in Chi­na.”

The re­lease con­firmed his com­ment and elab­o­rat­ed on the de­ci­sion.

GV-971, the drug in ques­tion, is an oral cap­sule con­sist­ing of an oligosac­cha­ride de­rived from sea­weeds. While re­searchers had ini­tial­ly thought it may work by al­ter­ing amy­loid be­ta, Green Val­ley ul­ti­mate­ly pro­posed that it works through the gut-brain ax­is, tam­ing down ner­vous sys­tem in­flam­ma­tion through mod­u­lat­ing gut mi­cro­bio­ta.

En­dorsed by some high-pro­file names in the US, its sur­prise 2019 ap­proval came at a time Bio­gen had scrapped two tri­als for ad­u­canum­ab, then the fore­most Alzheimer’s can­di­date around the world, be­fore ul­ti­mate­ly re­vers­ing course and steer­ing it to­ward a con­tro­ver­sial ap­proval. The stun­ning news out of Chi­na sparked a whole gamut of re­ac­tions among ex­perts, from cau­tious op­ti­mism to skep­ti­cism to be­wil­der­ment.

The Phase III study kicked off in Oc­to­ber 2020 and was de­signed to en­roll 2,046 pa­tients with mild to mod­er­ate Alzheimer’s.

In the end, Green Val­ley screened 1,308 par­tic­i­pants across 11 coun­tries or re­gions as of April 26, 439 of whom were ran­dom­ized in­to the study. Among them were 257 sub­jects in North Amer­i­ca, 118 in Eu­rope and 64 in Chi­na.

An in­de­pen­dent da­ta safe­ty mon­i­tor­ing board had met ear­li­er this year at the 10% en­roll­ment mile­stone to re­view the safe­ty da­ta and con­clud­ed that there were no safe­ty risks that would af­fect the con­tin­u­a­tion of the tri­al, the com­pa­ny not­ed.

How­ev­er, the do­mes­tic out­break that start­ed in ear­ly 2022 had a huge im­pact on GV-971 sales, which large­ly went through in-hos­pi­tal pre­scrip­tion, Green Val­ley said. Those al­so co­in­cid­ed with an en­roll­ment spike in oth­er coun­tries — trans­lat­ing to a short-term cash crunch. At the same time, the pan­dem­ic made off-line as­sess­ment of tri­al par­tic­i­pants dif­fi­cult, which con­tributed to a grow­ing dropout rate, all con­tribut­ing to ris­ing costs and risks.

Right now, the com­pa­ny sug­gest­ed that it will wind down the tri­al and fo­cus on the Chi­nese mar­ket. From a state­ment:

At about 10 mil­lion, our coun­try has the world’s largest Alzheimer’s pa­tient com­mu­ni­ty. As the pan­dem­ic al­le­vi­ates, Green Val­ley will ac­cel­er­ate the work of mar­ket and hos­pi­tal ac­cess af­ter GV-971 en­ters na­tion­al in­sur­ance, and fo­cus our re­sources on do­ing well on the ex­ist­ing mar­ket. With GV-971 demon­strat­ing treat­ment ben­e­fits on a grow­ing num­ber of pa­tients over the past two or so years on the mar­ket, more and more doc­tors will be­gin to rec­og­nize its unique clin­i­cal val­ue, it will be in­clud­ed in au­thor­i­ta­tive clin­i­cal guide­lines and ex­pert con­sen­sus as well as na­tion­al in­sur­ance. In the fu­ture it has the po­ten­tial to ben­e­fit even more Chi­nese pa­tients. Mean­while based on our mis­sion of “On­ly mak­ing med­i­cines that hu­mans most long for,” Green Val­ley will per­sist in our goal of bring­ing GV-971 to the in­ter­na­tion­al mar­ket, and restart in­ter­na­tion­al stud­ies of GV-971 when the sit­u­a­tion al­lows, so that this orig­i­nal AD med­i­cine can reach pa­tients around the world.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.