Jun­shi wins the race for first made-in-Chi­na PD-1 ap­proval as ex­ecs reap $394M IPO har­vest

It’s been a big day for Jun­shi Bio­sciences as it nabs Chi­na’s first snap ap­proval for a home­grown PD-1 af­ter re­port­ed­ly clos­ing a $394 mil­lion IPO in Hong Kong.

Con­di­tion­al­ly ap­proved un­der pri­or­i­ty re­view, tori­pal­imab is in­di­cat­ed for fast-grow­ing cas­es of melanoma, ac­cord­ing to the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion.

“Clin­i­cal tri­al re­sults of this prod­uct shows that in treat­ing pa­tients with un­re­sectable or metasta­t­ic melanoma who have failed pre­vi­ous sys­temic ther­a­pies, it reach­es an ob­jec­tive re­sponse rate of 17.3%, dis­ease con­trol rate of 57.5%, and 1-year sur­vival rate of 69.3%,” the NM­PA writes in a note. “The prod­uct’s mar­ket­ing ap­proval has a pos­i­tive im­pact on the se­lec­tion of clin­i­cal drugs for can­cer pa­tients.”

With 68 check­points crowd­ing the pipeline, this is like­ly to be first of many OKs from Chi­na’s rapid­ly evolv­ing reg­u­la­to­ry agency. Da­ta provider Pharm­Cube pre­vi­ous­ly told End­points News that In­novent Bi­o­log­ics, BeiGene (Cel­gene’s part­ner) and Jiang­su Hen­grui are all be­ing tipped for a mar­ket launch in the first half of 2019.

The ap­proval, which took nine months to process and tech­ni­cal­ly goes to Jun­shi’s sub­sidiary TopAl­liance, fol­lows those of Op­di­vo and Keytru­da, the two pi­o­neers in the field that’s been dom­i­nat­ing sales glob­al­ly.

While the ma­jor­i­ty of Jun­shi’s IPO pro­ceeds will go to­ward the con­tin­ued de­vel­op­ment and com­mer­cial­iza­tion of PD-1, parts will fund its oth­er pro­grams, in­clud­ing a PC­SK9 drug and a Hu­mi­ra biosim­i­lar, ac­cord­ing to an ear­li­er fil­ing.

Pric­ing at the bot­tom of the range, Jun­shi are sell­ing their shares at $2.48 (HK$19.38) each, Reuters re­port­ed. It’s set to be­gin trad­ing on De­cem­ber 24.

CI­CC is the sole spon­sor for the float while Cred­it Su­isse acts as a joint bookrun­ner.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

Overnight for­tunes are be­ing made in biotech these days — and it's both en­cour­ag­ing and more than a lit­tle bit scary

Just to complete the last leg of a running story I’ve been tracking for a few weeks, Olema $OLMA has come through its IPO from the Thursday night pricing at $19 a share with a market cap just north of $2 billion.

That leaves newly-named CEO Sean Bohen holding a batch of 1,110,896 shares with a strike price of $4.82. As of Tuesday morning, the stock is now trading at $53.40, giving him a portfolio value of $53.4 million. Not bad for someone who was hired in September.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.