CanSino Biologics, Inc.

The new facilities fall under the umbrella of MilliporeSigma’s €1 billion investment to advance mRNA technologies and build its global mRNA network. On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercialization. Tuesday, MilliporeSigma christened two new mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany. The company has invested €28 million in the sites, where it plans to hire 75 new staffers, MilliporeSigma said in a release. The new facilities will be able to tackle a full range of mRNA services, from pre-clinical to commercial-scale projects, MilliporeSigma said. Those offerings will include analytical development and biosafety testing specifically designed for mRNA technologies, the company added. The facilities fall under the umbrella of MilliporeSigma’s €1 billion investment to advance mRNA technologies and build its global mRNA network. Employing 27,000 worldwide, MilliporeSigma sells life sciences companies the tools and tech needed for testing and manufacturing. It also operates a contract testing, development and manufacturing organization to provide services for partners to advance their products. Meanwhile, following mRNA’s breakout success in the COVID-19 pandemic, many companies are pursuing the promising technology. Recently, England’s Centre for Process Innovation (CPI) opened a £26.4 million ($32 million) plant in Darlington, England. The site, called the RNA Centre of Excellence, will support the development and production of RNA products in clinical trials. In early August, China’s CanSino and AstraZeneca inked an mRNA manufacturing deal that’s set to last for at least 10 years. Under the deal, CanSino will use its mRNA manufacturing platform to support AZ on the R&D of certain vaccines.

CanSino Biologics' single-dose COVID shot is approved in 10 countries including Argentina, China, Mexico and Hungary. The vaccine has also been endorsed by the World Health Organization. CanSino Biologics' recent mRNA manufacturing tie-up with AstraZeneca represents just the tip of the iceberg, the company’s CEO has said. After jumping into the mRNA game back in 2018, CanSino has built a facility in Shanghai that can produce up to 200 million vaccine doses a year, the company’s co-founder and CEO Xuefeng Yu told Reuters in a recent interview. He described the mRNA deal with AZ, unveiled earlier this month, as a “business model" for the company, noting that it's just "the first step.” In early August, CanSino and AZ inked an mRNA manufacturing deal that’s set to last for at least 10 years. Under the deal, CanSino will use its mRNA manufacturing platform to support AZ on the R&D of certain vaccines. No financial details were disclosed. Now, Yu notes that alongside discussions with multinational pharma companies such as AZ, CanSino is also engaged in talks with potential partners in Malaysia, Indonesia, Mexico and Argentina. The company is open to help in “any market that may need our technology and product.” CanSino’s single-dose COVID shot is approved in 10 countries including Argentina, China, Mexico and Hungary. The vaccine has also been endorsed by the World Health Organization. As with many pandemic players, CanSino has seen COVID revenues tumble over the past few years, though Yu told Reuters the company expects no further significant write-downs involving unsold shots. In 2022, CanSino’s COVID shot brought in 878 million Chinese yuan ($122 million) in sales, down 80% compared with 2021. CanSino is also looking at other uses for its factory in Tianjin, China, which is used to churn out COVID vaccines. "That facility shares the same platform technology with other vaccines, it could easily be used for other vaccine production," Yu said. CanSino added mRNA to its COVID-19 efforts in the early days of the pandemic. In May 2020, the company signed a deal with Precision NanoSystems to develop an mRNA lipid nanoparticle vaccine. In January, the company reported early booster data for its mRNA prospect, dubbed CS-2034. A midstage trial showed the vaccine was better at inducing neutralizing antibodies than inactivated vaccines against both the original coronavirus strain and an omicron variant. Despite those promising early results, the company has paused its clinical trials for mRNA COVID shots and now plans to explore the technology for other diseases.

FDA approvals for Vyvanse generics, a Keytruda-Lenvima clinical trial flop and a dead deal between Adagene and ADC Therapeutics made our news this week. Generics to Takeda's blockbuster ADHD drug Vyvanse are now approved in the U.S. Merck and Eisai's Keytruda-Lenvima combo failed in another pivotal trial. ADC Therapeutics walked away from an antibody-drug conjugate partnership with Adagene. Plus more. 1. Amid shortage, FDA clears several generics of Takeda's popular ADHD drug Vyvanse The FDA has approved a slate of generics to Takeda’s ADHD drug Vyvanse. Teva, Sun Pharma, Actavis, Mylan and Hikma are among those that won the FDA’s blessing. The Takeda originator went into short supply a few weeks ago amid increased demand and a manufacturing hiccup. 2. Another Keytruda-Lenvima ambition is dashed as Merck, Eisai end head and neck cancer trial Merck and Eisai’s plan to combine Keytruda and Lenvima has suffered another setback. The companies decided to end a phase 3 trial in newly diagnosed PD-L1-positive head and neck cancer early. After reviewing interim data, they figured the combo likely won’t be able to outdo Keytruda alone at extending patients' lives. 3. ADC Therapeutics calls it quits on solid tumor collaboration with Adagene ADC Therapeutics has decided not to opt in on Chinese biotech Adagene’s antibody-drug conjugate program. The two teamed up in 2019 to combine Adagene’s antibody platform with ADC’s payload. ADC recently cut 17% of its workforce to save costs and to focus on FDA-approved Zynlonta and low-risk R&D projects. 4. Fujifilm Diosynth, planning for fast growth, reveals new structure and names unit leadership Fujifilm Diosynth Biotechnologies has reshaped its business structure. The company now has a large-scale strategic business unit headed by Kenneth Bilenberg in charge of the CDMO’s large facilities in Denmark and North Carolina supporting customers with large volume needs. Lee Kingsbury will oversee the company's small-scale production unit. 5. Glenmark, Baxter issue separate recalls for hypertension and cancer drugs Glenmark recalled 1,200 bottles of trandolapril and verapamil hydrochloride extended-release tablets produced at a site in India. The drugs are used to treat high blood pressure but were found to be subpotent in a three-month test. 6. Genexine's weekly growth hormone equal to Novo shot in phase 3, teeing up filing in China South Korean biotech Genexine said its once-weekly growth hormone, eftansomatropin alfa, matched Novo Nordisk’s daily Norditropin in a phase 3 trial in Chinese children with growth hormone deficiency. I-Mab, through its acquisition of Tasgen Biotech, owns rights to eftansomatropin alfa in China. 7. CanSino paused mRNA COVID vaccine development, looks for more CDMO deals (Reuters) China’s CanSino Biologics has paused development of mRNA COVID vaccines, co-founder and CEO Xuefeng Yu told Reuters. For its newly built mRNA facility in Shanghai, CanSino is now looking to manufacture vaccines for other companies, just as in its recent deal with AstraZeneca.