Chi­nese health au­thor­i­ty erects new gold stan­dard in on­col­o­gy R&D, spook­ing in­vestors in boom­ing field

The US has long been the leader in re­search and de­vel­op­ment in on­col­o­gy, but home­grown Chi­nese drug­mak­ers have jumped one hur­dle af­ter an­oth­er in mak­ing a name for them­selves. Now, the Chi­nese gov­ern­ment is erect­ing new hur­dles for its na­tive in­dus­try to leap, and — at least for now — it’s putting a slight chill on the field.

The Chi­nese health au­thor­i­ty NM­PA’s Cen­ter for Drug Eval­u­a­tion re­leased new guid­ance on on­col­o­gy R&D late last week, of­fer­ing a new gold stan­dard for how home­grown drug­mak­ers should de­ter­mine clin­i­cal ef­fi­ca­cy amid a boom­ing field for drug in­no­va­tion, ac­cord­ing to draft doc­u­ments.

The guid­ance broad­ly calls on Chi­nese drug­mak­ers to fo­cus on a pa­tient-cen­tric R&D ap­proach, fold­ing chang­ing stan­dards of care in­to clin­i­cal tri­als and sharp­en­ing re­search around ar­eas of un­met need. The newest roadmap comes amid a wave of Chi­nese in­vest­ment in drug de­vel­op­ment, par­tic­u­lar­ly on­col­o­gy, which has scored some mas­sive val­u­a­tions on the Hong Kong Ex­change and earned big-name part­ners in some of the largest multi­na­tion­al phar­mas.

As biotech in­vestor Brad Lon­car not­ed in a tweet, the draft doc­u­ments are most no­table for their in­sis­tence on us­ing best stan­dard of care as con­trol in late-stage clin­i­cal tri­als, rais­ing the bar high­er for on­col­o­gy drugs to show clin­i­cal ben­e­fit.

“When plan­ning to choose a place­bo or BSC as the con­trol drug, you should en­sure that there is no stan­dard treat­ment for this in­di­ca­tion in clin­i­cal prac­tice; when BSC is avail­able, BSC should be pre­ferred [as] a con­trol, not a place­bo,” ac­cord­ing to a trans­la­tion of the doc­u­ments.

As Lon­car notes, the guid­ance could go a long way to­ward rais­ing the qual­i­ty of Chi­nese on­col­o­gy R&D but could al­so have a sti­fling ef­fect on small­er play­ers look­ing for a mar­ket to ap­proval for their own drugs. In the mean­while, Chi­nese in­vestors ap­pear to have tak­en the guid­ance as a gen­er­al neg­a­tive on the field as a whole.

On Mon­day, ma­jor on­col­o­gy play­ers such as BeiGene (-1.93%), Hutchmed (-5.21%), Zai Lab (-3.49%) and Jun­shi Bio­sciences (-4.79%) were all down, po­ten­tial­ly un­der­scor­ing some con­cern over how the new guid­ance could make late-stage de­vel­op­ment more dif­fi­cult.

Where that ef­fect could be most ap­par­ent is in the PD-1 class, an area where Chi­na has shown a deep pipeline as late-stage en­trants in­to the glob­al and US mar­kets. All four drug­mak­ers list­ed above have at least one PD-1 can­di­date in the pipeline, with BeiGene — which has head­quar­ters in both Bei­jing and Cam­bridge, MA — part­ner­ing with phar­ma gi­ant No­var­tis on a glob­al li­cens­ing deal.

Chi­nese play­ers have not on­ly looked to get the eighth PD-1 across the fin­ish line in the US but are al­so look­ing to take an in­side track on the Chi­nese mar­ket as well. Jun­shi, which is part­nered glob­al­ly with Co­herus on PD-1 tori­pal­imab, re­cent­ly re­leased win­ning Phase III da­ta for its drug in na­sopha­ryn­geal can­cer, a con­di­tion that af­fects South­east Asian pa­tients at a dis­pro­por­tion­ate rate. Da­ta from that piv­otal study could un­der­gird an ap­proval in the US, which would be a first for the FDA and a sign of the grow­ing in­flu­ence of Chi­nese R&D on the glob­al drug mar­ket.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Yong Dai, Frontera Therapeutics CEO

Scoop: Lit­tle-known Or­biMed-backed biotech clos­es $160M round to start gene ther­a­py tri­al

Frontera Therapeutics, a China and US biotech, has closed a $160 million Series B and received regulatory clearance to test its first gene therapy stateside, Endpoints News has learned.

Led by the largest shareholder, OrbiMed, the biotech has secured $195 million total since its September 2019 founding, according to an email reviewed by Endpoints. The lead AAV gene therapy program is for an undisclosed rare eye disease, according to the source.

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invoX Pharma CEO Ben Toogood (L) and F-star CEO Eliot Forster

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

After more than a decade and a half of charting its own course, F-star Therapeutics will now settle under a new umbrella company.

The UK biotech will be acquired by invoX Pharma, a subsidiary of Hong Kong’s Sino Biopharm, in a roughly $161 million all-cash deal, the companies announced Thursday morning. F-star’s buyout will value its shares $FSTX at $7.12 apiece, nearly an 80% premium above Wednesday’s closing price.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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