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Frank Zhang (Imaginechina via AP Images)

Frank Zhang is in the clear af­ter Chi­nese au­thor­i­ties con­clude in­ves­ti­ga­tion with­out charges, com­pa­ny says

The former CEO of GenScript Biotech, a Hong Kong-listed CRO, is now apparently cleared of any further investigations or prosecution in China.

According to the company, Fangliang “Frank” Zhang, along with three current employees and one former employee of the company, have been notified that Chinese authorities have decided not to bring any charges against any entity or individuals. The decision means that the prosecution, procedure and any underlying investigation have now been concluded, the company said, and GenScript, its subsidiaries, Zhang and other people related to the investigation will not have any criminal liability attached to the investigation.

Weiguo Su, Hutchmed CEO

FDA hits Hutchmed, Jun­shi drugs with CRLs — fur­ther clar­i­fy­ing its stance on Chi­na-on­ly da­ta

The FDA is firmly shutting the door to China-only data when it comes to approving new cancer drugs — with some exceptions.

Just over a month after hitting Eli Lilly and Innovent’s sintilimab with a complete response letter, the agency sent back Hutchmed’s NDA for surufatinib, a kinase inhibitor that blocks VEGFR and FGFR, as a treatment of pancreatic and extra-pancreatic neuroendocrine tumors, citing similar concerns about data that mostly came from China.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis records an­oth­er tislelizum­ab win en route to bring­ing BeiGene's PD-1 to FDA's doors

The latest crop of data is out for Novartis and BeiGene’s tislelizumab as the partners look to pad their case for the PD-1 inhibitor’s expansion beyond China.

When combined with chemotherapy, the drug “significantly improved” the overall survival of patients with previously untreated unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) compared to chemo alone. That means the drug met its primary goal, according to the topline results reported by the Swiss Big Pharma Wednesday, in the Phase III RATIONALE 306 study, one of the drug’s more than a dozen late-stage trials across 35 countries.

Christopher Anzalone, Arrowhead Pharmaceuticals CEO

Vi­vo Cap­i­tal pitch­es $60M to bring Ar­row­head­'s RNAi meds to Chi­na via joint ven­ture

Generally speaking, any biotech hoping to have a presence in China has a number of options.

One could out-license its drugs to one of the transpacific players set up explicitly to be a bridge between Western medicines and the Chinese market (as Blueprint did with Zai Lab); form a joint venture with an established local pharma or CDMO (as Kite did with Fosun); or, more recently, partner up with a next-generation outfit that offers a more flexible deal structure (as ADC Therapeutics did with Overland).

Billy Cho, Zai Lab CFO (Zai Lab)

Fol­low­ing BeiGene, Zai Lab changes au­di­tors amidst SEC threat of delist­ing

In a move to comply with new US policy, Zai Lab announced Thursday that it was selecting KPMG as its new accounting firm, dropping the massive firm Deloitte as its previous accountants.

Zai Lab, along with BeiGene and Hutchmed, were initially named by the SEC last month as potentially in danger of losing their US listings after they were found to be in violation of a relatively new US law, the Holding Foreign Companies Accountable Act (HFCAA). The law, passed in late 2020, compels the SEC to identify public companies with auditing firms that cannot be reviewed or inspected by a nonprofit oversight board, the Public Company Accounting Oversight Board (PCAOB).

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Feng 'Franklin' Tao

Fed­er­al ju­ry con­victs Kansas chem pro­fes­sor on four counts in 'Chi­na Ini­tia­tive' case

Feng “Franklin” Tao, a chemistry professor at the University of Kansas, was found guilty on four of eight counts brought against him by the Department of Justice.

Tao was arrested in 2019 under the Trump administration’s controversial “China Initiative” — since deprioritized and renamed by the Biden administration after many failed prosecutions and criticism of fueling racial bias — and was suspended from his associate professor role at KU, barred from campus and has been wearing a tracking device on his ankle, NPR reported.

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Susan Galbraith, AstraZeneca EVP, oncology R&D

Spot­ting a gem from transpa­cif­ic biotech, As­traZeneca pays $25M cash to pick up a pre­clin­i­cal bis­pe­cif­ic an­ti­body

Looking to expand its oncology pipeline, AstraZeneca has turned to the east to pick up a next-gen drug against an emerging target.

Harbour BioMed, a Shanghai-based outfit that also has sizable teams in Cambridge, MA and Rotterdam, Netherlands, is out-licensing its CLDN18.2xCD3 bispecific antibody to AstraZeneca in exchange for $25 million upfront and up to $325 million in milestones plus royalties.

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Frank Fan, Legend founder and former CSO

Af­ter steer­ing made-in-Chi­na CAR-T all the way from ob­scu­ri­ty to ap­proval, Frank Fan re­signs from Leg­end

Now that Legend Biotech has secured its first approval for the J&J-partnered BCMA CAR-T, it’s saying goodbye to its founder and CSO.

Frank Fan — who began working on the cell therapy in 2014 when it was still housed in the Chinese CRO GenScript, took it to the international spotlight at 2017’s ASCO conference with stunning data, negotiated a deal with J&J’s Janssen for it with $350 million upfront and steered it to an FDA OK days ago — resigned from the company effective March 30, the company revealed Friday.

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Charles Lieber (AP Photo/Michael Dwyer)

Har­vard sci­en­tist Charles Lieber seeks ac­quit­tal in 'ill-con­ceived' Chi­na Ini­tia­tive case

Years after getting swept up in the controversial Trump-era “China Initiative” — and months after being convicted on six felony charges — notable Harvard scientist Charles Lieber is seeking an acquittal or new trial, as his lawyer maintains that the jury’s decision would not stand today.

Lieber was convicted in December of lying to the federal government about his ties to China’s Thousand Talents Program. He was arrested back in 2020 as part of the divisive “China Initiative,” which was set up to stop the purported theft of American intellectual property by the Chinese government.

Most Chi­nese firms could keep their US list­ings un­der draft frame­work — re­port

US regulators could have full access to auditing reports from many of the 200-plus China-based companies listed in New York as soon as the middle of 2022, according to a Bloomberg report.

Currently in the drafting stage, the framework from the China Securities Regulatory Commission and other national agencies would let most Chinese firms keep their US listings, Bloomberg said, citing anonymous sources. But those that hold sensitive data could still be delisted, the news service reported.