Lingshi Tan, dMed founder, chairman and CEO (via dMed website)

A boom­ing mar­ket pro­pels Chi­na CRO to a $100M raise. Is an IPO next?

Chi­na’s cost ad­van­tage and po­si­tion as the world’s sec­ond-largest pre­scrip­tion drug mar­ket has fu­eled its red-hot CRO in­dus­try over the last few years. On Thurs­day, Shang­hai-based dMed Bio­phar­ma­ceu­ti­cal wrapped up a $100 mil­lion Se­ries C round, which it says will blaze the path to an IPO.

Found­ed in 2016 by Ling­shi Tan, Pfiz­er’s for­mer gen­er­al man­ag­er of Chi­na R&D, dMed boasts sites in ma­jor cities across Chi­na, the US, and one lo­ca­tion in Bel­gium. It hooked a $50 mil­lion Se­ries B just last year, and opened a US reg­u­la­to­ry af­fairs of­fice in DC to help Chi­nese biotechs sub­mit US fil­ings and serve as a con­duit for US drug­mak­ers look­ing to out­source de­vel­op­ment to Chi­na.

“A key goal in the cur­rent round is to ex­pand our in­vestor base to in­clude long-term pub­lic mar­ket-fo­cused in­sti­tu­tions and strate­gic part­ners in or­der to pre­pare for a fu­ture IPO,” Tan said in a state­ment.

Fi­deli­ty Man­age­ment & Re­search led the Se­ries C, with a help­ing hand from new in­vestors Se­quoia Cap­i­tal Chi­na, Kaiser Foun­da­tion Hos­pi­tals and E Fund.

Chi­na’s CRO mar­ket is ex­pect­ed to hit $27.04 bil­lion in 2024, ex­pand­ing at a com­pound an­nu­al growth rate of 27.06%, ac­cord­ing to a Kon­cept An­a­lyt­ics re­port pub­lished ear­li­er this year. Sev­er­al fac­tors are con­tribut­ing to the growth, the re­port states, in­clud­ing in­creas­ing bi­o­log­ics sales, ris­ing geri­atric pop­u­la­tion, grow­ing in­vest­ment in the health­care sec­tor, an ac­cel­er­at­ing num­ber of IND fil­ings, in­clin­ing R&D ex­pen­di­tures and un­met need.

“Dur­ing pre­vi­ous years, the CRO in­dus­try has grown from lim­it­ed clin­i­cal tri­al ser­vices provider to a full-ser­vice in­dus­try char­ac­ter­ized by broad re­la­tion­ships with clients and ser­vice of­fer­ings that en­com­pass the en­tire drug de­vel­op­ment process,” the re­port reads.

In 2017, sweep­ing reg­u­la­to­ry re­forms more close­ly aligned Chi­na’s rules with those in the US and Eu­rope, re­sult­ing in an in­flux of ap­pli­ca­tions from Chi­nese biotechs to reg­is­ter drugs in the US, ac­cord­ing to dMed. Chi­na joined the In­ter­na­tion­al Coun­cil for Har­mon­i­sa­tion of Tech­ni­cal Re­quire­ments for Phar­ma­ceu­ti­cals for Hu­man Use (ICH), an or­ga­ni­za­tion that brings to­geth­er reg­u­la­tors of the bio­phar­ma­ceu­ti­cal in­dus­try glob­al­ly to as­sess the sci­en­tif­ic and tech­ni­cal as­pects of drug de­vel­op­ment. IND fil­ings jumped from 11 in 2016 to 20 in 2017, with an­oth­er 38 in 2018 and the first quar­ter of this year, dMed an­nounced.

“Chi­na is vast­ly dif­fer­ent than two years ago. Gov­ern­ment re­forms and join­ing the ICH have helped clear the way for in­no­v­a­tive Chi­nese com­pa­nies to de­vel­op and launch cut­ting-edge ther­a­pies glob­al­ly,” Tan said last year, up­on an­nounc­ing the DC of­fice. “A key part of dMed’s mis­sion is to sup­port the glob­al­iza­tion of drug de­vel­op­ment and help build world-class clin­i­cal, reg­u­la­to­ry, bio­met­rics and phar­ma­covig­i­lance ca­pa­bil­i­ties in Chi­na.”

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,400+ biopharma pros reading Endpoints daily — and it's free.

Jenny Rooke (Genoa Ventures)

Ear­ly Zymer­gen in­vestor Jen­ny Rooke re­flects on 'chimeras' in biotech, what it takes to spot a $500M gem

When Jenny Rooke first heard of Zymergen back in 2014, she knew she was looking at something different and exciting. The Emeryville, CA biotech held the promise of blending biology and technology to solve a huge unmet need for cost-effective chemicals — of all things — and a stellar founding team to boot.

But back then, West Coast venture capitalists didn’t see in Zymergen the one thing they were looking for in a winning biotech: therapeutic potential. Rooke, however, saw an opportunity and made her bets. Seven years later, that bet is paying off in a big way.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 107,400+ biopharma pros reading Endpoints daily — and it's free.

Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Rubertis made no secret of IPO plans for Centessa, his 10-in-1 legacy play. Barely two months later, the S-1 is in.

The hot-off-the-press filing depicts the same grand vision that the longtime VC touted when he did the rounds in February: Take the asset-centric mindset that he’s been preaching at Medicxi over the years, and roll up a bunch of biotech upstarts, with unrelated risk profiles, into 1 pharma company that can carry on the development at scale.

Steffen Schuster, ITM CEO

Ra­dio­phar­ma re­mains hot as Ger­many's ITM rais­es $109M to ad­vance neu­roen­docrine can­cer pro­gram

The world of radiopharmaceuticals has been heating up over the last few years, and Thursday saw another company focused on the field pull in a new nine-figure raise.

Germany’s ITM, or Isotopen Technologien München, scored a $109 million round of loan financing to push forward its precision oncology pipeline and fund late-stage development for its lead program. As part of the agreement, the loan will convert to shares in the event of future financial or corporate transactions, ITM said.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.