Eli Lil­ly will li­cense in Re­gor Ther­a­peu­tics ther­a­pies for meta­bol­ic dis­or­ders, as a part of an agree­ment an­nounced Fri­day that will give the Chi­nese biotech an up­front pay­ment of up to $50 mil­lion, part of which is an eq­ui­ty in­vest­ment.

In a vague­ly word­ed re­lease, Lil­ly said it has a li­cense for cer­tain Re­gor “in­tel­lec­tu­al prop­er­ty” and will have an op­tion to ex­tend that li­cense. In ex­change, Lil­ly will over­see glob­al clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion for any ther­a­pies, with the ex­cep­tion of Chi­na, Macau, Hong Kong and Tai­wan. Re­gor, a Shang­hai-based com­pa­ny, will re­serve the rights to these re­gions.

The com­pa­ny is el­i­gi­ble for up to $1.5 bil­lion in po­ten­tial pay­ments based on pre­clin­i­cal, clin­i­cal and com­mer­cial mile­stones, as well as tiered roy­al­ties from sales.

Re­gor CEO Xi­ayang Qiu said that the col­lab­o­ra­tion is, in part, a recog­ni­tion of Re­gor’s core tech­nol­o­gy, the Com­put­er Ac­cel­er­at­ed Ra­tio­nal Dis­cov­ery plat­form. CARD, an­oth­er in a long line of fan­ci­ly named biotech com­pu­ta­tion­al plat­forms, is de­signed to cre­ate a more ef­fi­cient process for the dis­cov­ery of new drugs.

Min Zhong

Through CARD, the team has ad­vanced a num­ber of prod­ucts in its pipeline in just two years, in­clud­ing RGT-587 for on­col­o­gy, which is set to en­ter Phase I tri­als, and and RGT-075 to tar­get a glucagon-like pep­tide 1 re­cep­tor hor­mone, which stim­u­lates glu­cose-in­duced in­sulin se­cre­tion. That can­di­date is en­ter­ing Phase II/III tri­als.

Wenge Zhong

The com­pa­ny was found­ed in 2018 by a team that in­cludes two Pfiz­er vet­er­ans and three — Qiu and Min Zhong, and CTO Wenge Zhong — who used to work for Am­gen’s Chi­nese R&D op­er­a­tions. Re­gor’s fo­cus so far has been on on­col­o­gy, meta­bol­ic dis­eases and au­toim­mune dis­eases.

“Re­gor’s tech­nol­o­gy will al­so al­low Lil­ly to fur­ther ac­cel­er­ate in­no­va­tion and de­liv­er break­through ther­a­pies in obe­si­ty and di­a­betes,” Ruth Gi­meno, the VP of di­a­betes re­search at Lil­ly, said in a state­ment.

Ruth Gi­meno

In Feb­ru­ary, Lil­ly Asia Ven­tures led the Se­ries B fundrais­ing round, in which the com­pa­ny raised $90 mil­lion to back their clin­i­cal de­vel­op­ment. It al­so land­ed an in­vest­ment from Loy­al Val­ley Cap­i­tal, a com­pa­ny that played a role in fi­nanc­ing the so­cial me­dia video app Tik­Tok, and was list­ed as a top-10 in­flu­en­tial pri­vate eq­ui­ty firm in Chi­na.

“To­geth­er we are work­ing hard for a bet­ter world by in­no­v­a­tive and trans­for­ma­tive med­i­cines which make mean­ing­ful im­pacts to pa­tients glob­al­ly,” Loy­al Val­ley founder Andy Lin said in a state­ment at the time.

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.