Jingwu Zang, I-Mab acting CEO

I-Mab ex­pands man­u­fac­tur­ing for mul­ti­ple myelo­ma an­ti­body; Gran­ules is­sued 'mi­nor ob­ser­va­tion­s' af­ter in­spec­tion

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.

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.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

Endpoints Premium

Premium subscription required

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

David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The notorious drug testing company Valisure, which has made a name for itself by forcing FDA’s hand with some of its safety-related uncoverings, received a letter this week after the FDA uncovered violations at its Connecticut-based testing lab in 2021.

The letter, which was sent on Dec. 5, stated that the FDA is “concerned” that Valisure was not aware of  drug supply chain security requirements.

WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Bags of shred­ded docs: In­di­an drug­mak­er Lupin hand­ed a Form 483 by FDA in­spec­tors

The generics manufacturer Lupin has been given another Form 483 from the FDA this year.

US regulators inspected Lupin’s pharmaceutical manufacturing site in the town of Mandideep, India from Nov. 14 through Nov. 23, with the 14-page report marking 16 observations.

The inspection report stated that the site did not have the appropriate controls over its computer systems to ensure that changes in “master production” or records are only done by authorized personnel, along with written procedures not being established to conduct annual reviews of records associated with drug batches.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.

WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,300+ biopharma pros reading Endpoints daily — and it's free.