Dec 17, 2020

Nicole DeFeudis Associate Editor 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.” AUTHOR Overview The licensing of two Chimeric Antigen Receptor (CAR) T cell therapies for the treatment of B cell malignancies underscores the potential of cell based immune therapy to deliver impressive durable clinical responses¹. These products are autologous in nature which involves collecting immune cells from the patient that are used to manufacture the CAR T cells. Once produced, these CAR T cells are then reinfused as the clinical product to the patient. However, there are significant challenges to autologous therapy, including product production time (which currently takes weeks) during which the patient’s disease may progress, and the highly variable quality of the starting material, which can result in manufacturing failures. Read More December 15, 2020 05:08 PM ESTUpdated December 16, 02:18 AM Jason Mast Editor As the FDA prepared to OK the first Covid-19 vaccine last week, AstraZeneca sent instructions to its US investigators for what to do when some of their volunteers will suddenly be left to choose between staying in the British pharma’s study or receiving an FDA-authorized vaccine. The document, whose contents were described to Endpoints News by two investigators and whose existence was confirmed by another, says that investigators are allowed to individually unblind participants who become eligible for the Pfizer or Moderna vaccine and tell them which arm of the AstraZeneca study they were in. The participant can then decide whether to receive the authorized vaccine. Whichever they choose, they will be allowed to remain in the study for long-term followup. Keep reading Endpoints with a free subscription Unlock this story instantly and join 95,600+ biopharma pros reading Endpoints daily — and it's free. SUBSCRIBE Jason Mast Editor At last week’s advisory committee, Pfizer executives shot down a proposal from a Stanford expert on how to keep a blinded study going even after the vaccine becomes available. On Thursday, the FDA brought the same expert back, who again argued for the blinded plan and gave an even more forceful — albeit polite — denunciation of Moderna’s plan. “This is a precedent you might not want to set,” Steven Goodman, associate dean of clinical and translational research at the Stanford University School of Medicine. Keep reading Endpoints with a free subscription Unlock this story instantly and join 95,600+ biopharma pros reading Endpoints daily — and it's free. SUBSCRIBE John Carroll Editor & Founder Five years after Novartis stepped up with a sizable deal that gave them worldwide rights to Surface Oncology’s lead cancer drug, GlaxoSmithKline is coming in at the other end of the pipeline, snagging a preclinical natural killer drug designed to whip up a more effective attack on cancer cells. Unlike a lot of the preclinical collaborations we’ve seen, GSK is also freighting this with a significant amount of cash: $85 million upfront plus $730 million in milestones. And they see this new addition to the oncology pipeline as a prime candidate for future combos — all the rage these days. Keep reading Endpoints with a free subscription Unlock this story instantly and join 95,600+ biopharma pros reading Endpoints daily — and it's free. SUBSCRIBE Amber Tong Senior Editor After J&J and Allergan shone a bright spotlight on the role of NMDA receptors in psychiatric diseases, Novartis has jumped in with both feet by bagging a neuroscience partner. Cadent Therapeutics is getting $210 million upfront and $560 million in milestones tied to its 3-drug pipeline — with indications spanning schizophrenia and movement disorders. “The NMDA receptor is one of the most important targets in the brain, it really controls neuronal function, I would describe it as part of the very nuts and bolts of the nervous system,” Gopi Shanker, the interim co-head of neuroscience at the Novartis Institutes for BioMedical Research, told Endpoints News. “And so modulation — the right kind of and right amount of modulation — is critical to balancing efficacy and safety and historically it’s been really difficult developing safe and effective modulators of the NMDA receptor.” Keep reading Endpoints with a free subscription Unlock this story instantly and join 95,600+ biopharma pros reading Endpoints daily — and it's free. SUBSCRIBE