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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