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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Iain McGill, Quell CEO

Eu­ro­pean in­vestors pour $156M to beat Blue­stone, Third Rock and RA Cap­i­tal in multi­bil­lion-dol­lar race to the clin­ic

Amid burgeoning efforts to create a new type of cell therapy out of regulatory T cells — whether by channeling or blocking their immunosuppressive power — Quell Therapeutics wants to shoot for a first.

If everything goes well, the Syncona-backed biotech will be in the clinic early next year, marking what it calls the historic feat of dosing a patient with a CAR-Treg with multiple edited genes.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Jonathan Montagu (L) and Gerry Harriman, HotSpot co-founders

HotSpot gets hot­ter with $100M raise to push to­ward clin­ic

HotSpot Therapeutics, the allostery-focused biotech that works on what it calls “natural hotspots” — hence the name — is getting a bit hotter in its valuation from investors. And to that end they’ve raised $100 million.

The four-year-old AI computational biotech started by two former Nimbus execs announced this morning that it closed its Series C round right at the line of a 9-figure investment, courtesy of some big investors.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.