via Hisun

Pri­vate eq­ui­ty meets Chi­na biotech: PAG in­fus­es $540M to gain con­trol of Hisun's biosim­i­lar sub­sidiary

Pri­vate eq­ui­ty firm PAG has emerged as the win­ner in a bid­ding war for Hisun Bio­Ray, the biotech unit of Chi­nese gener­ics and API mak­er Zhe­jiang Hisun Phar­ma­ceu­ti­cal.

Un­der the deal Hong Kong-based PAG is shelling out $540 mil­lion in ex­change for 58% own­er­ship of Bio­Ray — from its two R&D and man­u­fac­tur­ing cen­ters in Taizhou and Hangzhou to na­tion­wide com­mer­cial op­er­a­tions — while the moth­er com­pa­ny re­tains the oth­er 42%.

Hisun, which is state-owned, boasts of the deal as the largest pri­vate eq­ui­ty in­vest­ment in Chi­na’s biotech sec­tor to-date.

“This trans­ac­tion marks an im­por­tant mile­stone in mixed own­er­ship re­form of Chi­na’s state-owned sec­tor,” Hisun chair­man Guop­ing Jiang said in a state­ment. “By bring­ing in for­eign di­rect in­vest­ment to sup­port the de­vel­op­ment of Chi­na’s bio­phar­ma­ceu­ti­cal in­dus­try, Hisun Phar­ma­ceu­ti­cal can sharp­en its fo­cus while sup­port­ing Hisun Bio­Ray’s fu­ture de­vel­op­ment.”

Over 40 po­ten­tial in­vestors were vy­ing for a con­trol­ling share of the young com­pa­ny, he added, which was just launched this Jan­u­ary.

But with Hisun Phar­ma — a bi­o­log­ics play­er since 2003 that has seen ups (li­cens­ing pacts) and downs (FDA warn­ing let­ters) — on their back, Bio­Ray is not your av­er­age biotech fledg­ling. It cur­rent em­ploys 700 staffers and mar­kets a re­com­bi­nant hu­man TN­Fɑ fu­sion pro­tein for rheuma­toid arthri­tis, anky­los­ing spondyli­tis and pso­ri­a­sis. There are more than 10 oth­er on­col­o­gy and au­toim­mune projects in the pipeline, in­clud­ing a biosim­i­lar of Hu­mi­ra they plan to launch around the end of the year as An­jian­ning.

“PAG’s in­vest­ment will sup­port and ac­cel­er­ate the de­vel­op­ment of our pipeline and clin­i­cal tri­al progress, fur­ther strength­en our com­pet­i­tive ad­van­tage, and ex­pand our foot­print in the lat­est gen­er­a­tion of in­no­v­a­tive bi­o­log­ics and biosim­i­lars,” Bio­Ray CEO Haib­in Wang said in a state­ment.

For PAG, which has $30 bil­lion un­der man­age­ment, this marks yet an­oth­er biotech bet fol­low­ing re­cent in­vest­ments in Rongchang Phar­ma­ceu­ti­cals (al­so known as Re­ne­Gen) and Al­pham­ab On­col­o­gy.

Suin­ing Xi­ao, its part­ner and chair­man of Chi­na, will be­come chair­man of Bio­Ray.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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