Christian Hogg, Hutchmed CEO

Hutchmed files for $600M+ IPO in Hong Kong as lead on­col­o­gy drug su­r­u­fa­tinib awaits FDA's good graces

In on­col­o­gy, a flush of Chi­nese-de­vel­oped drugs has the bio­phar­ma in­dus­try re­think­ing the poles of pow­er in R&D as the blos­som­ing na­tion con­tin­ues to make a name for it­self and pick up bun­dles of cash in the process. Now, as its lead drug faces a piv­otal FDA re­view, the com­pa­ny for­mer­ly known as Chi-Med is plant­i­ng its flag on home soil with a mas­sive pub­lic of­fer­ing.

Hutchmed — re­cent­ly re­named from Chi-Med, or Hutchi­son Chi­na MediTech — will look to raise $603 mil­lion as part of a Hong Kong IPO that serves as a home­com­ing of sorts for the Chi­nese-based on­col­o­gy play­er, which has list­ed on Nas­daq since 2016.

The com­pa­ny plans to of­fer up to 104 mil­lion shares at around HK$45 per share — or rough­ly $5.80. Hutchmed will trade un­der the tick­er “13” on the ex­change, com­ple­ment­ing the com­pa­ny’s Nas­daq tick­er $HCM.

Hutchmed al­ready has a five-firm group of cor­ner­stone in­vestors on board in The Car­lyle Group, the Cana­da Pen­sion Plan In­vest­ment Board, Gen­er­al At­lantic, HBM Health­care In­vest­ments and CI­CC Grandeur Fund, which com­bined have pledged to buy up $325 mil­lion worth of shares or about 54% of the of­fer­ing.

The Chi­nese firm is cur­rent­ly await­ing FDA re­view for its oral on­col­o­gy med su­r­u­fa­tinib for non-pan­cre­at­ic neu­roen­dro­crine tu­mors — which Hutchmed filed for rolling sub­mis­sion in May. The drug pre­vi­ous­ly scored a fast track des­ig­na­tion with the agency in April.

Ac­cord­ing to a prospec­tus filed with the ex­change, Hutchmed in­tends to use 50% of the pro­ceeds to ad­vance late-stage tri­als with that drug, mar­ket­ed as Su­lan­da in Chi­na, as well as Eli Lil­ly-part­nered col­orec­tal can­cer drug fruquin­tinib, mar­ket­ed as Elu­nate; As­traZeneca-part­nered in­ves­ti­ga­tion­al MET in­hibitor savoli­tinib; and can­di­dates HM­PL-689 and HM­PL-523, which are PI3K and SYK in­hibitors, re­spec­tive­ly, for blood can­cers.

The rest of the pro­ceeds will be divvied up be­tween BD, ad­vanc­ing the ear­ly pipeline, cor­po­rate strat­e­gy and in­ter­nal hires, Hutchmed said.

Hutchmed was the first Chi­nese com­pa­ny to bring an in-house on­col­o­gy drug to mar­ket in that coun­try with fruquin­tinib, which was ap­proved as a third-line ther­a­py for metasta­t­ic CRC. Surafa­tinib hit the Chi­nese mar­ket in Jan­u­ary 2021 for non-pan­cre­at­ic NET and savoli­tinib is up for Chi­nese re­view with a po­ten­tial launch ex­pect­ed with­in weeks.

With its Chi­nese drug dis­cov­ery en­gine in full swing — sev­en oth­er can­di­dates are sweep­ing through pre­clin­i­cal and ear­ly hu­man stud­ies — Hutchmed has looked to break in­to the US mar­ket, where on­ly BeiGene’s Brukin­sa has earned an ap­proval as a Chi­nese-de­vel­oped on­col­o­gy drug. Su­r­u­fa­tinib is the fur­thest along in that ef­fort, but both fruquin­tinib and savoli­tinib have start­ed reg­is­tra­tional stud­ies state­side.

With a po­ten­tial ap­proval ex­pect­ed in the com­ing months, Hutchmed has al­ready start­ed build­ing out a com­mer­cial team for su­r­u­fa­tinib. The com­pa­ny is al­ready at 1,300 em­ploy­ees spread across its glob­al en­ter­prise.

The rise of on­col­o­gy drug de­vel­op­ment has in­ject­ed a new chal­lenger in­to the glob­al mar­ket­place and be­gun to shift the poles of pow­er in R&D in that space. Com­pa­nies like Saman­tha Du’s Zai Lab and Jun­shi Bio­sciences have earned a rep­u­ta­tion as on­col­o­gy spe­cial­ists in Chi­na and have earned mas­sive pub­lic rais­es to show for it.

In Sep­tem­ber, Zai Lab closed a $761 mil­lion Hong Kong IPO to dri­ve its in-li­cens­ing busi­ness mod­el and then fol­lowed that up with a $750 mil­lion of­fer­ing in US de­pos­i­to­ry shares in April. The com­pa­ny spe­cial­izes in tak­ing in-li­censed on­col­o­gy drugs to mar­ket, and re­cent­ly signed a deal with Mi­rati to mar­ket in­ves­ti­ga­tion­al KRAS in­hibitor ada­gra­sib in the Greater Chi­na area.

Jun­shi, mean­while, closed its own $450 mil­lion Hong Kong IPO back in Jan­u­ary 2019 as part of its push to bring its own in-house PD-1 drug tori­pal­imab to mar­ket along­side in­ter­na­tion­al part­ner Co­herus. The part­ners read out Phase II da­ta at this year’s AS­CO show­ing a sig­nif­i­cant im­prove­ment in PFS for a tori­pal­imab-chemo com­bo over chemo alone in pa­tients with na­sopha­ryn­geal can­cer, a dis­ease that af­fects South­east Asians at a pro­por­tion­al­ly high­er rate.

That study, dubbed JUPITER-02, would be the first sole­ly Chi­nese-run piv­otal tri­al to win an FDA ap­proval, if it cross­es the fin­ish line.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Tien Lee, Aardvark Therapeutics CEO

Emerg­ing from stealth mode, Aard­vark rounds up enough cash to put its lead drug through Prad­er-Willi PhII

When Aardvark Therapeutics CEO Tien Lee started his work on the biotech’s lead candidate, appetite suppression was the goal for the small molecule.  Soon after, his team started to see added benefits with lower blood glucose levels and anti-inflammatory activity. On the tail end of that, the company has emerged from stealth mode and announced today that they’ve raised enough cash in the B round to cover mid-stage development work.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

Covid-19 roundup: Pfiz­er im­pos­es vac­cine man­date for US work­ers; WHO calls for mora­to­ri­um on boost­ers, while some coun­tries make plans any­way — re­port

As the US struggles to keep pace with the fast-spreading Delta variant, big companies like Walmart and Disney are imposing vaccine mandates for some workers. It may come as no surprise that Pfizer — the Big Pharma behind the US’ first authorized Covid-19 vaccine — is joining them.

Pfizer will start requiring all US employees and contractors to get vaccinated, or participate in weekly Covid-19 testing, spokesperson Pamela Eisele told Reuters. Workers outside the US are strongly urged to get a vaccine if they can, according to the report. And those with medical conditions or religious objections can seek accommodations.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.

UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.