Gary Rieschel, Duane Kuang, Nisa Leung, William Hu (Qiming)

Qim­ing's Chi­na-fo­cused $1.1B new fund brings glob­al haul to $5B with­in 1 week — but the dis­tri­b­u­tion won't be even

In case you’re still won­der­ing, the glob­al ven­ture train for bio­phar­ma is def­i­nite­ly chug­ging along.

Qim­ing Ven­ture Part­ners has just closed $1.1 bil­lion for its sev­enth fund, bring­ing the grand to­tal of new biotech funds close to $5 bil­lion just over the past week. To be sure, the Chi­na-based VC al­so in­vests in medtech, di­ag­nos­tics, health­care ser­vices, in­for­ma­tion tech­nol­o­gy, ar­ti­fi­cial in­tel­li­gence, en­ter­prise ser­vices, con­sumer in­ter­net and e-com­merce — but over the past 14 years it’s es­tab­lished it­self as a pre­mier ear­ly-stage biotech backer with an eye for play­ers that even­tu­al­ly make it big.

The size of the new fund eclipsed both of the pre­vi­ous funds: Fund VI brought in $935 mil­lion while Fund V had $638 mil­lion.

The firm — which has of­fices in Shang­hai, Bei­jing, Shen­zhen and Hong Kong — ac­knowl­edged that there were chal­lenges caused by the Covid-19 pan­dem­ic, as well as geopo­lit­i­cal un­cer­tain­ties. That said, high qual­i­ty teams are still draw­ing com­mit­ments to ad­vance treat­ments in the long run, echo­ing com­ments by ARCH, Flag­ship, ven­Bio and Deer­field.

So is there go­ing to be plen­ty of cash to go around through and af­ter the cri­sis? Like his VC coun­ter­parts, man­ag­ing part­ner Gary Ri­eschel pre­dicts “ex­treme se­lec­tiv­i­ty with­in VC port­fo­lios” since many tranched funds tied to tri­al mile­stones could now be at risk.

But Qim­ing is al­so in a unique place — lit­er­al­ly.

“Chi­na has less ex­po­sure here be­cause it ap­pears as though tri­al ini­ti­a­tion and re­cruit­ment has re­sumed in Chi­na, where­as in the U.S. it may be sev­er­al more months,” he wrote in an email to End­points News.

Case in point: Yes­ter­day Zai Lab, for whom Qim­ing co-led a Se­ries A back in 2014, struck a $190 mil­lion deal to de­vel­op and com­mer­cial­ize Re­gen­eron’s CD20XCD3 bis­pe­cif­ic. Part of the ap­peal, ac­cord­ing to the US drug­mak­er, is that the col­lab­o­ra­tion would bol­ster en­roll­ment of re­gion­al pa­tients in­to glob­al tri­als in B-cell non-Hodgkin lym­phoma.

Mean­while CanSi­no, an­oth­er Qim­ing port­fo­lio com­pa­ny, is by far the fron­trun­ner in Chi­na’s ef­forts to de­vel­op a vac­cine against Covid-19. The biotech, fa­mous for de­vel­op­ing the coun­try’s first and on­ly Ebo­la vac­cine, got the green light to be­gin hu­man test­ing for its ade­n­ovirus-based can­di­date in late March. That was days af­ter Mod­er­na’s ul­tra-fast mR­NA pro­gram en­tered the clin­ic state­side.

Nisa Le­ung, who heads the health­care team with William Hu, not­ed that over 60 of Qim­ing’s port­fo­lio com­pa­nies are help­ing in dif­fer­ent as­pects to com­bat the coro­n­avirus in Chi­na and glob­al­ly.

Now lead­ing Qim­ing’s US op­er­a­tions in Seat­tle, Ri­eschel is most­ly en­trust­ing the Chi­na side of things to Le­ung, Hu and his co-founder Du­ane Kuang. But he’s keep­ing a close eye on the IPO mar­ket there.

“We had Venus Medtech go out in HK and Sany­ou on the STAR board in the last few months. As well as Rock­robo on the Tech­nol­o­gy side,” he wrote. “It ap­pears as though the Chi­nese cap­i­tal mar­kets are func­tion­ing, if not at the same scale yet as be­fore.”

There are over 30 Qim­ing-backed com­pa­nies in the IPO pipeline, ac­cord­ing to a re­lease.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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