A pho­to log of my week in Shang­hai, host­ing the first an­nu­al US-Chi­na Bio­phar­ma In­no­va­tion and In­vest­ment Sum­mit

I’ve re­turned from a week in Shang­hai af­ter host­ing our first BI­IS con­fer­ence in Chi­na. It was ex­tra­or­di­nar­i­ly suc­cess­ful from my stand­point as the chief ex­ec­u­tive here at End­points News. (Yes, we’ll be re­turn­ing even big­ger in 2019.) This year we were joined by 250 del­e­gates who came to par­tic­i­pate in two days of meet­ings fea­tur­ing some of the most rec­og­niz­able names in the biotech world — which is led firm­ly by the Unit­ed States and Chi­na now.

The BI­IS con­fer­ence was cre­at­ed from scratch to gath­er bio­phar­ma lead­ers from around the world in an ul­tra-mod­ern fo­rum con­duct­ed in both Eng­lish and Chi­nese. Re­al­time trans­la­tions were pro­vid­ed in both lan­guages. The goal was to pro­vide com­mon space for serendip­i­tous ac­tion and part­ner­ship be­tween del­e­gates and speak­ers. Thanks to the hard work by the joint team at End­points and Pharm­cube, that vi­sion be­came a re­al­i­ty this week.

John Car­roll’s fire­side chat with Fa­heem Has­nain


Vivek Ra­maswamy lis­tens to re­al-time trans­la­tion of Dr. Jin­hui Gu’s keynote


Nisa Le­ung of Qim­ing Ven­tures de­liv­ers her keynote ad­dress 


Karen Liu, founder of 3E BioVen­tures, ad­dress­es del­e­gates


Grace Lu of Rus­sell Reynolds mod­er­ates a pan­el on the chal­lenges of re­cruit­ing tal­ent in this com­pet­i­tive bio­phar­ma mar­ket


Mem­bers of the End­points team at gala din­ner


I want­ed to give read­ers some brief im­pres­sions along­side a lengthy vi­su­al log in­to what the sum­mit was like. I’ll start with of­fi­cial pic­tures from the con­fer­ence and mix in some shots from my per­son­al iPhone as well to­ward the end.

by Ar­salan Arif


John Oyler BeiGene


John Oyler, the Amer­i­can CEO and founder of Chi­na-based Beigene, is a true pi­o­neer in the US-Chi­na bio­phar­ma sphere, and as such we se­lect­ed him as one of our chair­peo­ple for the BI­IS sum­mit. He kicked off the pro­ceed­ings with a keynote and took meet­ings at BI­IS through­out the day, stay­ing for the gala din­ner Mon­day evening.

Two things he said stuck out to me: 1) Chi­na will be the top coun­try for bio­med­ical clin­i­cal re­search in the near fu­ture, full stop; and 2) Chi­na en­ables an al­ter­na­tive busi­ness mod­el for bio­phar­ma where com­pa­nies no longer have to re­ly on ex­ist­ing US pric­ing schemes to be vi­able.


John Car­roll End­points News


Our own John Car­roll was up next. He has over one mil­lion words on the record over his 15 years of biotech cov­er­age. Over the course of the week I met count­less Chi­nese bio­phar­ma ex­ec­u­tives who re­count­ed sto­ries to me when they first start­ed read­ing John Car­roll. As long­time read­ers know, both John and I were at a pre­vi­ous com­pa­ny, pub­lish­ing un­der a dif­fer­ent ban­ner, pri­or to found­ing End­points News in June 2016. It was in­spir­ing to hear how many ex­ec­u­tives John has helped learn the ins and outs of bio­phar­ma from his cov­er­age ear­ly in their ca­reers, and now them­selves have moved in­to the ranks of peo­ple John and his team of ed­i­tors at End­points cov­er. John has been say­ing “Chi­na is com­ing” for eight years now. Chi­na has ful­ly ar­rived. There’s tremen­dous pro­fes­sion­al sat­is­fac­tion in be­ing on the ground, in full force, cov­er­ing it for our read­ers now.


Leon Chen 6 Di­men­sions


Chair­ing day two is one of the most in­flu­en­tial Chi­nese ven­ture cap­i­tal­ists in the world: Leon Chen, the found­ing part­ner and CEO of 6 Di­men­sions Cap­i­tal, the prod­uct of a re­cent merg­er of Front­line BioVen­tures and WuXi Ven­tures.

Dr. Chen is a mem­ber of the Ex­pert Re­view Pan­el for the Chi­nese Cen­tral Gov­ern­ment’s “1000 Tal­ents Pro­ject” and thus has keen in­sights in­to the re­cent phe­nom­e­non of Chi­nese tal­ent com­ing back af­ter train­ing and get­ting a foothold in Amer­i­ca. He’s led a num­ber of in­vest­ments in the life sci­ences, in­clud­ing Curon, Hua Med­i­cine, In­novent, Ada­gene, and many more. If you read End­points News, Leon Chen is a reg­u­lar fix­ture when we re­port on the lat­est star­tups out of both Chi­na and the Unit­ed States.


Mingde Yu 于明德 Chair­man, Chi­nese Phar­ma­ceu­ti­cal En­ter­pris­es As­so­ci­a­tion

Jin­hui Gu 顾金辉 Di­rec­tor, Of­fice of Ma­jor Drug De­vel­op­ment


We were de­light­ed to host two ma­jor fig­ures from Chi­na’s key cen­tral gov­ern­ment func­tions. No un­der­stand­ing of Chi­na is com­plete with­out the per­spec­tive of these se­nior lead­ers and how they view this cur­rent mo­ment in the de­vel­op­ment of Chi­na’s bio­phar­ma in­dus­try. For Eng­lish-on­ly BI­IS at­ten­dees, re­al-time trans­la­tions were key, as one of our cen­tral goals was to make every part of the con­fer­ence ac­ces­si­ble to all re­gard­less of lan­guage.

Mingde Yu de­liv­ered a keynote on Mon­day morn­ing which cen­tered around the re­mark­able progress be­ing made in Chi­na. He’s cur­rent­ly the chair­man of the Chi­nese Phar­ma­ceu­ti­cal En­ter­pris­es As­so­ci­a­tion, pre­vi­ous­ly hav­ing been in mul­ti­ple lead­er­ship roles in key cen­tral gov­ern­ment func­tions.

And on Tues­day we heard from Dr. Jin­hui Gu, di­rec­tor of the Na­tion­al Health Com­mis­sion’s Na­tion­al Sci­ence and Tech­nol­o­gy Ma­jor Pro­jects for New Drug De­vel­op­ment. He ad­min­is­ters a gov­ern­ment grant pro­gram of 33 bil­lion RMB which sup­ports al­most every new drug de­vel­op­ment pro­gram that has re­ceived mar­ket ap­proval in re­cent years. With more than 15 years work­ing ex­pe­ri­ence in Chi­na’s high­est reg­u­la­to­ry agen­cies, he made it clear that there is a clear man­date for Chi­nese-led in­no­v­a­tive drug de­vel­op­ment right from the top. And while much progress has been made, we’re still in the ear­ly days of Chi­na’s con­tri­bu­tion here.


Fred Co­hen Vi­da Ven­tures


Fred Co­hen, the co-founder and se­nior man­ag­ing di­rec­tor at Vi­da Ven­tures, de­liv­ered an in­spir­ing keynote ad­dress on Mon­day morn­ing which cen­tered around en­tre­pre­neur­ship and the lessons Chi­nese bio­phar­ma in­vestors might learn from the US bio­phar­ma ven­ture ex­pe­ri­ence.

As many in our au­di­ence know, on top of his in­vest­ing ca­reer Dr. Co­hen was at UCSF from 1980-2014 hold­ing mul­ti­ple re­spon­si­bil­i­ties rang­ing from re­search sci­en­tist to chief of en­docrinol­o­gy and me­tab­o­lism. He’s pub­lished over 200 peer re­view ar­ti­cles, and was elect­ed to the In­sti­tute of Med­i­cine and Na­tion­al Acad­e­my of Sci­ences in 2004, and the Amer­i­can Acad­e­my of Arts and Sci­ences in 2008. He’s keen­ly in­ter­est in Chi­na and we had a great chat about the CRO busi­ness in Asia-Pa­cif­ic and just how much it dif­fers from what we see state­side. (Hint: They’re crit­i­cal­ly im­por­tant to the bio­phar­ma in­fra­struc­ture in Chi­na, much more so than what we see state­side.)


Nisa Le­ung Qim­ing Ven­tures


Nisa Le­ung is the man­ag­ing part­ner of one of Chi­na’s top VC firms which man­ages over US$4 bil­lion in as­sets and has in­vest­ed in over 270 com­pa­nies. Ear­li­er this year we at End­points News named her as one of the top 12 Chi­na VCs that you need to know. She point­ed­ly brought up the trade war be­tween the US and Chi­na and said al­though it will have a neg­a­tive im­pact, we need to pre­pare for a sec­ond Trump term and weath­er the storm be­cause the US-Chi­na re­la­tion­ship pre­dates and will out­last Trump.


Fa­heem Has­nain Gos­samer Bio


Fa­heem Has­nain, the ex-CEO at Re­cep­tos and now co-founder of Gos­samer Bio, had a juicy fire­side chat with John Car­roll.  He told the au­di­ence how glum the mood was in the room with his up­per man­age­ment team af­ter they had just closed the $7 bil­lion Cel­gene sale. Glum, you read that right. Fa­heem re­count­ed for the BI­IS au­di­ence in raw de­tail what John Car­roll had al­ready re­port­ed on for the on­line End­points au­di­ence back in Jan­u­ary this year, and he took it a step fur­ther in Shang­hai ex­plain­ing just why Cel­gene isn’t pleased with him these days. He’s mak­ing it as easy as pos­si­ble for tal­ent to flock back to what he and his team are do­ing at Gos­samer.


Vivek Ra­maswamy Roivant


Vivek Ra­maswamy gave one of the most provoca­tive speech­es of the sum­mit, and then im­me­di­ate­ly sat down with John Car­roll for a fire­side chat to de­fend his pre­dic­tions. His bold call that bio­phar­ma will have fig­ured out all of its “col­lec­tive ac­tion prob­lems” by 2035 in­stant­ly sent lo­cal WeChat groups abuzz with chat­ter.

Lo­cal Chi­nese in­vestors and en­tre­pre­neurs that I spoke with were keen­ly aware of the $4 bil­lion Vivek has raised for his Vants and the 34 pro­grams they’ve got in the clin­ic. Lat­er on in the day I saw him around the Four Sea­sons, hav­ing lunch with sev­er­al del­e­gates and be­ing in­ter­ro­gat­ed about his plans for Sino­vant and Data­vant.


Brad Lon­car Lon­car In­vest­ments


Brad Lon­car is well known to End­points read­ers as a con­trib­u­tor to this pub­li­ca­tion, and as a biotech an­a­lyst and in­de­pen­dent in­vestor who has cre­at­ed mul­ti­ple life sci­ences ETF prod­ucts for in­vestors — his two ini­tial prod­ucts are $CN­CR and $CHNA.


This trip was my first time to Chi­na. I could not have asked for a bet­ter part­ner than the im­pres­sive team at Pharm­cube. Pro­duc­ing an in­ter­na­tion­al event in 90 days from a stand­ing start, which is what the team above did, can on­ly be done by a group of peo­ple who gen­uine­ly en­joy work­ing to­geth­er. The cru­cible can get hot. Above, pic­tured from left to right, is Richard Wang, Jean Cheng, my­self, Am­ber Tong, Jian­hua Jiang, and Chaowei Guo. Be­low is the en­tire Pharm­cube-End­points Chi­na team.

If you haven’t been to Chi­na yet, but fol­low Chi­na with in­ter­est, the su­perla­tives that come with Shang­hai all ap­ply. It’s spec­tac­u­lar. Un­like any city I’ve ever been to. The area that our con­fer­ence was in, Pudong, was grass fields 10 years ago. Now tow­ers of spec­tac­u­lar ar­chi­tec­ture shoot to the sky, con­nect­ed with thought­ful in­fra­struc­ture at pre­cise­ly the right widths and den­si­ty.

I’m from Kansas, came of age in DC and the I-95 cor­ri­dor, been all over the West Coast, trav­eled ex­ten­sive­ly across these Unit­ed States. And we have no frame of ref­er­ence for this kind of de­vel­op­ment.

There are some pre­dic­tions which this sum­mit has gal­va­nized for me — name­ly, that Chi­na will be the num­ber one na­tion for clin­i­cal re­search in due time — and oth­er pre­dic­tions that I’m am­biva­lent on. Ei­ther way, there will be more di­a­logue and End­points News and our part­ner Pharm­cube will con­tin­ue to fa­cil­i­tate the very best high-lev­el meet­ing that US-Chi­na bio­phar­ma pro­fes­sion­als can turn to. And you can ex­pect that on an an­nu­al ba­sis.

Here’s a sun­rise view from my ho­tel room at the Four Sea­sons.

Lat­er here I’m work­ing from the 35th floor on Sat­ur­day be­fore the con­fer­ence. The views are ar­rest­ing.

There’s a qual­i­ty to it that I couldn’t quite put my fin­ger on.

Be­ing from Kansas, I’m used to “free­dom-lov­ing coun­try” where in­di­vid­u­al­ism and a right to pri­va­cy is sim­ply the de­fault. So to get bio­met­ri­cal­ly scanned up­on ar­rival at the air­port, you take no­tice. Every­thing is reg­is­tered. Every­thing. My fel­low Kansan Brad Lon­car tweet­ed about los­ing his pass­port and iPad on a bench Tues­day night af­ter our #BI­IS18 con­fer­ence con­clud­ed.

If he’d done that in NYC, prob­a­bly Kansas too, his iden­ti­ty would have been stolen and his new Ap­ple prod­uct as good as gone. In­stead the po­lice showed up the next morn­ing at his ho­tel room be­cause some­one had turned it in, and the au­thor­i­ties knew where to find Brad Lon­car.

That kind of sys­tem is new to a Kansan.

Glu­cose Biosen­sor Sys­tems CEO Har­ry Sime­oni­dis an­nounces news at the con­fer­ence


Rus­sell Reynolds Grace Lu in­tro­duces her pan­el on tal­ent re­cruit­ment


Vivek Ra­maswamy gives an ex­plain­er on his Vants


End­points founder/CEO Ar­salan Arif mod­er­ates a pan­el on what US ex­ecs want from Chi­nese deals


Janet Mc­Ni­cholas with Jones Day speaks with Vi­da Ven­tures’ Fred Co­hen


Pharm­cube’s Jean Cheng 程静 mod­er­ates a pan­el on the Chi­nese on­col­o­gy pipeline


John Car­roll and Vivek Ra­maswamy fire­side chat


Na­tal­ie Chen of the Hong Kong stock ex­change ex­plains their new rules on list­ing


John Oyler, Founder and CEO of BeiGene, de­liv­ers a keynote ad­dress


Nisa Le­ung meets with del­e­gates


2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

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Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

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UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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Gilead claims Tru­va­da patents in HHS’ com­plaint are in­valid

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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