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Coherus CEO Denny Lanfear (L) and Junshi CEO Li Ning

Two months af­ter CRL, FDA ac­cepts Co­herus, Jun­shi's re­sub­mis­sion for PD-1 stud­ied in Chi­na

China-only clinical data has not fared well before the FDA this year. But in one case, the regulatory agency might be willing to budge a little.

Coherus BioSciences, the US partner for Junshi Biosciences, announced Wednesday morning that the FDA has accepted a BLA resubmission for its PD-1 drug two months after a CRL. The companies are seeking a nod for toripalimab plus chemotherapy in first-line advanced recurrent or metastatic nasopharyngeal carcinoma (NPC), plus toripalimab alone for second-line and later recurrent or metastatic NPC after platinum-containing chemotherapy.

Ling Zhen, ClinChoice CEO

UP­DAT­ED: With Lil­ly's back­ing, a CRO with roots in Chi­na bags $150M round to fu­el glob­al growth

A renamed CRO with deep ties in the US and China has pulled in another round of capital.

ClinChoice, formerly Fountain Medical Development, has completed a $150 million Series E funding round, using the cash to continue its planned expansion.

According to ClinChoice CEO Ling Zhen, the funds from the round will be part of a two-pronged strategy centered around the company’s physical growth. One area will be going toward new solutions such as remote monitoring and data analytics but the other area will be toward a geographic expansion.

Vas Narasimhan, Novartis CEO (Patrick Straub/Keystone via AP)

No­var­tis, BeiGene lay out front­line PhI­II da­ta for PD-1 drug as sec­ond-line PDU­FA date looms

As the FDA prepares to decide on Novartis and BeiGene’s PD-1 drug tislelizumab in the second-line setting, the pair is already preparing for its potential use as patients’ first treatment option.

The two companies announced at an ESMO congress on gastrointestinal cancer Thursday that first-line patients on the anti-PD-1 antibody plus chemotherapy reported a median overall survival of 17.2 months versus 10.6 months for patients on chemo plus placebo. This meets the study’s primary endpoint of overall survival. The risk of death in patients on the PD-1 drug was also 34% lower than patients on placebo, clocking in a p-value of under 0.0001.

Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

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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As­traZeneca con­tin­ues to build out its pres­ence in Chi­na with new COPD drug man­u­fac­tur­ing site

AstraZeneca has been growing its presence in China over the past several years, and the pharma’s latest venture in the country will see it establish a manufacturing process for COPD treatments.

According to a press release, translated from Chinese, AstraZeneca officially announced it will expand its investment in China and plans to spend some cash to construct a production and supply base as well, as a regional headquarters in the port city of Qingdao, Shandong in eastern China. Qingdao will also be home to an innovation center focused on rare diseases, a life science innovation park and an industrial fund.

Albert Wong, Hong Kong Science and Technology Parks CEO

Boehringer In­gel­heim to in­cu­bate biotechs with Hong Kong R&D leader

Following the suit of AstraZeneca last February, Boehringer Ingelheim will team up with a leading R&D hub in Hong Kong to seed biotechs.

Whereas AstraZeneca focused on cancer drugs and diagnostics, the German giant will work with Hong Kong Science and Technology Parks on incubating infectious disease and immunology drug developers.

HKSTP and Boehringer, through its venture arm, will support the upstarts with up to $6 million HK (about $600,000 USD) each to bankroll early-stage operations and clinical trials, said Grace Lau, head of HKSTP’s institute for translational research, in a statement.

#AS­CO22: A small Chi­na biotech play­er makes its de­but at AS­CO with promis­ing da­ta on its GPRC5D mul­ti­ple myelo­ma drug

With all the headlines jumping out of ASCO this year, you’d be forgiven for overlooking the upbeat data coming from a low-profile Chinese biotech. But it’s worth a close second look.

Shanghai-based OriCell, a private player, has highlighted a round of promising Phase I results for its personalized GPRC5D-directed CAR-T OriCAR-017. Directed at a small group of treatment-resistant patients suffering from multiple myeloma, the biotech reported a 100% overall response rate with 60% stringent CRs.

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Legend Biotech CEO Ying Huang

UP­DAT­ED: #AS­CO22: Leg­end, J&J say Carvyk­ti holds up past the two-year mark as pair preps for po­ten­tial sec­ond nod

CHICAGO — The second BCMA CAR-T approved, Carvykti, has shown it can stay effective at almost 28 months of median follow-up, with overall response rate remaining consistent at 98% among the 97 patients treated.

Those are the latest data from Legend Biotech’s Carvykti, in partnership with J&J’s Janssen, shared Saturday at the annual ASCO meeting. At 28 months follow-up from the Phase Ib/II CARTITUDE-1 study, 70% of patients were still alive and 55% experienced no progression in their multiple myeloma. Median OS and PFS have not been reached yet.

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