Updated: BioNTech sends mRNA Covid-19 vaccines to China for … – Endpoints News

Chi­na has opened up its doors to a for­eign Covid-19 vac­cine for the first time, though not for its own cit­i­zens, a Ger­man gov­ern­ment spokesper­son told Reuters on Wednes­day.
BioN­Tech’s mR­NA vac­cines have been sent to Chi­na to meet the goal of vac­ci­nat­ing 20,000 Ger­man ex­pa­tri­ates there, a spokesper­son for the Ger­man em­bassy in Wash­ing­ton con­firmed to End­points News. There will be ad­di­tion­al ship­ments, the spokesper­son said, with­out pro­vid­ing de­tails on when or how many dos­es would be de­liv­ered. The shots will be pro­vid­ed free to Ger­mans over 12 years old and will be shipped to Ger­man em­bassies and com­pa­nies across the coun­try.
About 11,500 dos­es ar­rived re­cent­ly for Ger­man ex­pa­tri­ates in Bei­jing, Shang­hai, Guangzhou, Shenyang and Cheng­du, BioN­Tech said Thurs­day.
The news comes over a month af­ter Ger­man Chan­cel­lor Olaf Scholz an­nounced in Bei­jing that an agree­ment had been made be­tween the two coun­tries to al­low the vac­cine’s use in Chi­na for ex­pats. Scholz said at the time that he hoped the Chi­nese gov­ern­ment would al­low its own cit­i­zens to use the vac­cine, ac­cord­ing to Reuters.
Ear­li­er in De­cem­ber, the Ger­man gov­ern­ment au­tho­rized Chi­nese cit­i­zens liv­ing in Ger­many to have ac­cess to Chi­na’s Sino­vac shot, one of the first vac­cines au­tho­rized for emer­gency use by the Chi­nese gov­ern­ment in 2020. A 2021 study in Chi­na found that two dos­es and a boost­er of Sino­vac’s shot didn’t pro­duce ad­e­quate lev­els of pro­tec­tive an­ti­bod­ies against the omi­cron vari­ant.
Chi­nese cit­i­zens pre­vi­ous­ly on­ly had ac­cess to vac­cines de­vel­oped in their home coun­try, and none of the vac­cines ap­proved for wide do­mes­tic use in Chi­na are mR­NA-based, ac­cord­ing to a re­port from BNN Bloomberg.
In Oc­to­ber, Mod­er­na backed out of on­go­ing ne­go­ti­a­tions to send its mR­NA vac­cines be­cause Chi­na asked for all of the in­tel­lec­tu­al prop­er­ty rights. Hand­ing over de­tailed IP is one of on­ly two ways that Chi­na cur­rent­ly al­lows for­eign vac­cines. The oth­er op­tion is to build a man­u­fac­tur­ing com­pa­ny in the coun­try with a Chi­nese part­ner.
There have been some ex­cep­tions in the coun­try’s spe­cial ad­min­is­tra­tive re­gions.
BioN­Tech part­nered with Shang­hai Fo­s­un Phar­ma­ceu­ti­cal and an­nounced in No­vem­ber that the Health Bu­reau of the Hong Kong Spe­cial Ad­min­is­tra­tive Re­gion is­sued an Emer­gency Use Au­tho­riza­tion for a boost­er dose of BioN­Tech’s Omi­cron BA.4/BA.5-adapt­ed bi­va­lent vac­cine.
And Macau al­so grant­ed the boost­er a Spe­cial Im­port Au­tho­riza­tion.
Ed­i­tor’s note: Up­dat­ed with a state­ment from BioN­Tech.
Drug pricing watchdog ICER said that the uncertainty in the health benefits of two potential Alzheimer’s drugs makes it challenging to assess their future cost-effectiveness, according to a draft report released Thursday morning.
The report evaluates Biogen and Eisai’s lecanemab and Eli Lilly’s donanemab, both of which are amyloid-clearing antibody drugs due for FDA decisions in the coming weeks and months. The FDA’s deadline for a decision on lecanemab’s accelerated approval is Jan. 6, while the deadline for donanemab is estimated to be in February.
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One of the pioneers of first-gen CAR T has now swooped in to buy a second-gen cell therapy player with some stellar scientific ties, impressive early responses and a clinical record that includes a high-profile blowup in the clinic that killed several patients.
Gilead sub Kite is putting out word today that it’s nailed down the buyout of Tmunity, a cell therapy spinout out of Penn that was derailed by lethal toxicity.
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On Jan. 26, the FDA’s vaccines adcomm will meet to discuss the future of Covid-19 booster shots and variant strain selection moving forward, and CBER Director Peter Marks yesterday previewed some of what will be discussed in that meeting.
As the bivalent booster uptake has stalled, particularly among children, Marks is now pointing to ways to simplify the process.
The VRBPAC adcomm won’t only look at what the composition of these Covid-19 vaccines should be, and what’s the timing for selecting new strains, but also how often strain selection should take place, he said, noting that the FDA is “trying to get to some sense of normalcy for how we treat vaccinations.”
The first CD20xCD3 bispecific antibody will soon become available in the US following an FDA approval disclosed Thursday night.
Roche and Genentech’s mosunetuzumab was greenlit as a third-line treatment for adults with relapsed or refractory follicular lymphoma. FDA’s accelerated approval of the therapy now branded as Lunsumio comes seven days early and follows suit behind the European Union, which cleared the drug on June 3, 2022.
After more than three decades of instituting government policies to improve clinical trial diversity, certain racial and ethnic groups, as well as adolescents, older adults, women, low-income individuals, and individuals from rural communities “remain consistently underrepresented in cancer clinical trials,” the Government Accountability Office said in a new report released this week.
The GAO report explains many of the federal efforts around increasing diversity, particularly in federally-funded cancer trials, with DOD, HHS, and VA developing research collaborations, modifying research practices, reducing barriers to patient participation with payments and via other means, and collecting and sharing more data.
Roche upgraded its emergency use authorization for Actemra in certain hospitalized Covid-19 patients to a full FDA approval, the company announced Wednesday, as cases climb in the US.
The approval comes roughly a year and a half after the monoclonal antibody treatment received an EUA to treat hospitalized patients 2 years and older who are also receiving systemic corticosteroids and require supplemental oxygen, ventilation or life support. While the approval is only for adults, Actemra will continue to be available for younger patients under the EUA.
Gilead finally gained FDA approval on Thursday for lenacapavir, its closely-watched capsid inhibitor for HIV-1, the most common type of HIV.
Lenacapavir will be marketed in the US as Sunlenca for heavily pretreated HIV-1 patients who are failing their current antiretroviral regimen. The long-acting subcutaneous injection is administered just twice a year, offering an alternative to cumbersome daily pill regimens.
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Despite a year littered with setbacks, ProQR Therapeutics is closing 2022 on a high note.
The Dutch biotech is expanding its RNA editing collaboration with Eli Lilly, with a potentially large payoff down the line, the companies announced early Thursday morning.
Lilly is putting down $75 million in upfront cash and equity, with a $50 million option to expand the deal further in the future. There’s also now $3.75 billion in biobucks on the table, compared with $1.25 billion when the pair signed their original deal in September 2021.
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While all has gone quiet on the M&A rumor front for Seagen, one of the pioneers in antibody-drug conjugates, Merck has been racking up deal after deal for ADCs out of a Chengdu, China-based partner.
In the latest of three tie-ups with Kelun-Biotech, Merck is likely entering the history books with a deal that could balloon to $9.3 billion in back-end payments — that’s if seven ADCs make it to market. That’s a huge if, as drug R&D is notorious for an approximately 10% success rate, but the immediate boost to Kelun’s coffers is not small: $175 million plus an intended equity investment of undisclosed size.
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Bioscience & Technology Business Center
The University of Kansas
Lawrence, Kansas
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