Chi­na-based bio­phar­ma I-Mab has land­ed a part­ner­ship with Shang­hai’s Hangzhou Qiantang New Area to man­u­fac­ture drugs lo­cal­ly and speed up the com­pa­ny’s path to­ward com­mer­cial­iza­tion.

The deal will help it com­mer­cial­ize felzartam­ab, a mon­o­clon­al an­ti­body that tar­gets mul­ti­ple myelo­ma, in Chi­na. Hangzhou has start­ed op­er­at­ing on what it calls a Phase I site and start­ed con­struc­tion in De­cem­ber on an 80,000 square-me­ter spot for Phase II.

“To­day’s an­nounce­ment demon­strates the Com­pa­ny’s com­mit­ment to trans­lat­ing our sci­en­tif­ic in­no­va­tion in­to clin­i­cal and com­mer­cial val­ue as soon as pos­si­ble so that we can pro­vide more high-qual­i­ty, af­ford­able op­tions for pa­tients through lo­cal­ly-man­u­fac­tured, in­no­v­a­tive drugs,” CCO Yifei Zhu said. “This brings us one step clos­er to our new com­mer­cial mod­el that in­te­grates man­u­fac­tur­ing, dis­tri­b­u­tion and sales.”

Mul­ti­ple myelo­ma is the sec­ond most com­mon hema­to­log­ic ma­lig­nan­cy in Chi­na, mak­ing up 1% of all can­cers and 13% of all blood ma­lig­nan­cies.

Co-founder Jing­wu Zang be­came the act­ing CEO at the start of the year when Joan Shen stepped down to pur­sue oth­er in­ter­ests at the close of 2021. The com­pa­ny made head­lines in 2020 with a $2.9 bil­lion li­cens­ing deal with Ab­b­Vie for its CD47 drug, and in Sep­tem­ber, there were re­ports the com­pa­ny was con­sid­er­ing sell­ing a stake of it­self.

Gran­ules is­sued ‘mi­nor ob­ser­va­tions’ af­ter in­spec­tion

An In­di­an phar­ma was is­sued three ob­ser­va­tions by the FDA, fol­low­ing a pre-ap­proval in­spec­tion at the end of last month, the com­pa­ny said.

Gran­ules Phar­ma­ceu­ti­cals, in Chan­til­ly, Vir­ginia, was in­spect­ed from Jan. 24-28.

“We are glad to have com­plet­ed yet an­oth­er au­dit with mi­nor ob­ser­va­tions that we will re­spond to with­in the stip­u­lat­ed time pe­ri­od,” di­rec­tor Priyan­ka Chig­u­ru­pati said in a state­ment.

The com­pa­ny had an ab­bre­vi­at­ed new drug ap­pli­ca­tion. Ap­proved by the FDA at the end of Jan­u­ary for its potas­si­um chlo­ride bioe­quiv­a­lent treat­ment of low potas­si­um lev­els. It al­so re­ceived ap­proval for its AN­DA  for Bupro­pi­on Hy­drochlo­ride ex­tend­ed-re­lease tablets to treat de­pres­sion and sea­son­al af­fec­tive dis­or­der. That marked the 50th AN­DA ap­proval from the FDA.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.