Chi­nese start­up with Mer­ck vet at the helm ac­quires rights to Oys­ter Point's eye dis­ease nasal spray

With the Chi­nese drug mar­ket start­ing to bear fruit, West­ern drug­mak­ers have looked to wig­gle their way in, of­ten lean­ing on lo­cal part­ners to do the grunt work on the ground. With so many Chi­nese com­pa­nies play­ing the will­ing host, a fledg­ling start­up with a Mer­ck vet­er­an lead­ing the way will now take on an­oth­er West­ern part­ner of its own.

Ji Xing Phar­ma­ceu­ti­cals has ac­quired the Greater Chi­nese rights to Oys­ter Point Phar­ma’s nasal spray for dry eye dis­ease can­di­dates OC-01 and OC-02 in ex­change for $17.5 mil­lion in up­front cash and 0.75% eq­ui­ty in the emerg­ing Chi­nese biotech, the part­ners said Thurs­day.

The deal comes with $204.8 mil­lion in biobucks and serves as the sec­ond West­ern part­ner­ship for Ji Xing, an RTW In­vest­ments-backed com­pa­ny head­quar­tered in Shang­hai that emerged from stealth last month with an undis­closed B round in hand.

Joe Ro­manel­li

The firm is helmed by Joe Ro­manel­li, the for­mer pres­i­dent of Mer­ck Chi­na who over­saw the launch of 20 prod­ucts in that re­gion, in­clud­ing I/O su­per­star Keytru­da and HPV vac­cine Gar­dasil, which the biotech said was the biggest drug by rev­enue in Chi­na pro­duced by a multi­na­tion­al.

Dur­ing his four-year tenure with the New Jer­sey drug­mak­er, Ro­manel­li over­saw its evo­lu­tion from the sev­enth-largest multi­na­tion­al drug­mak­er op­er­at­ing in Chi­na to the sec­ond by the time he jumped ship.

“Stim­u­lat­ing nat­ur­al tear film pro­duc­tion may be a par­a­digm-chang­ing way to treat dry eye dis­ease, which af­fects more than 150 mil­lion pa­tients in Chi­na,” Ro­manel­li said about the Oys­ter Point deal. “We are ex­cit­ed to part­ner with the Oys­ter Point team, who are in­no­v­a­tive pi­o­neers fo­cused on de­vel­op­ing ther­a­peu­tics for oph­thalmic dis­eases, and bring both OC-01 and OC-02 to Chi­na.”

Ji Xing’s oth­er West­ern part­ner­ship, a li­cens­ing deal with Mile­stone Phar­ma­ceu­ti­cals, is al­so for a nasal spray, this time for parox­ys­mal supraven­tric­u­lar tachy­car­dia and oth­er car­dio­vas­cu­lar in­di­ca­tions. The drug, dubbed etri­pamil, is cur­rent­ly in Phase III test­ing.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Vikram Sheel Kumar, Clear Creek Bio CEO

In search for next-gen Covid treat­ment, Pfiz­er taps tiny biotech for re­search deal

Pfizer has inked a deal to develop a new Covid therapy with Clear Creek Bio — a 10-person biotech out of RA Capital with an office in Cambridge, MA, but one that operates fully remotely.

Paxlovid has become a big moneymaker for Pfizer this year, projecting $22 billion in sales on the year. But the Big Pharma has begun its search for a next-generation Covid antiviral and potential combination therapies as supply of Paxlovid greatly eclipses actual use of the antiviral.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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