Baricitinib

11月11日，鲁抗医药发布公告，公司于近日收到国家药品监督管理局核准签发的注射用CIGB-814的《药物临床试验批准通知书》，同意本品进行类风湿关节炎适应症临床试验。 CIGB-814为1类创新药，国内外尚未有同类药品。目前市场上同适应症药品主要为甲氨蝶呤、来氟米特、柳氮磺吡啶、艾拉莫德、羟氯喹、托法替布、巴瑞替尼、依那西普、英利西单抗、阿达木单抗和托珠单抗等。据相关数据显示，2023年国内类风湿性关节炎相关药物市场销售额约为48亿元。 注射用CIGB-814临床拟用于成人活动性类风湿性关节炎。截至目前，鲁抗医药该项目累计研发投入约为8205.65万元人民币。

Can Ken Mulvany save BenevolentAI? About a decade ago, Mulvany helped found the company as part of the first generation of AI-focused biotech startups. It soared to a $2 billion valuation, pitching a “bioscience machine brain” that would discover cures in a way traditional R&D efforts were incapable of doing. The last two years have been a sobering reality check, including the clinical failure of its lead drug, rounds of layoffs and a sinking stock price. Now, Mulvany — who led BenevolentAI during its better days — has returned. He believes there’s still a future for the company he started. And he’s pushed way back onto the board, spending millions of his own money to do so, and is in control following last month’s exit of CEO Joerg Moeller , who lasted less than a year in the role. “This company wasn’t living up to its potential, and it matters to me,” Mulvany, who’s taken on the title of executive chairman, said in an interview with Endpoints News . “I’m not looking for a new CEO. I’m not going to look for a new CEO for quite some time. The company needs to get back on its feet and promote itself and the accomplishments that it has.” Mulvany said he’s in the company’s London office daily, spending most of his time on product and business development decisions. He has a lot at stake, with a 27% ownership interest, and after spending $5 million to $10 million on his effort to rejoin the board. (Those costs were, he says, driven by a legal structure encompassing legal headquarters in Luxembourg, an office in London and stock trading on a Dutch exchange.) A recovery will be no small feat, and won’t be cheap. Despite an 11-year history, the company now has no drug programs beyond Phase 1 studies and is at a financial precipice: Its latest earnings, from the end of June, reported £38 million ($49 million) in cash and equivalents and a £32 million ($42 million) operating loss for the first six months of 2024. “You don’t have to look very far to see that the company needs to raise money,” Mulvany said. A major part of Mulvany’s job will be convincing shareholders there’s something worth investing in — and making sure that’s the case. Co-founder Michael Brennan has rejoined as chief strategy and financial officer, with a mandate to spend more time talking to investors. Mulvany said BenevolentAI hasn’t done a roadshow with investors and didn’t have a broker until recently. “The company became somewhat insulated,” Mulvany said. “It’s spent its entire public life unengaged with the investment community.” He also wants to boost its dealmaking efforts. He called building a pipeline important, but said they’d look for partnerships to bankroll larger trials, rather than relying on shareholder money. The company’s sole clinical-stage drug is an experimental treatment for ulcerative colitis, a small molecule targeting PDE10, which its AI platform linked with the inflammatory disease. Mulvany said the company will “need a partner” to advance the drug. It would be hard to issue new equity in any case. The stock is below €1 a share, and it continues to burn through cash. But what Mulvany lacks in time, he makes up for in confidence. “If I thought there was somebody who would be able to do that better than I could, I would have brought that person in,” he said. Mulvany has been successful in biotech before, co-founding a neuro startup called Proximagen that was sold in 2012 for about $347 million . He co-founded BenevolentAI in 2013 to bring together computer scientists and life-science researchers, turning heads with a $115 million raise in 2018 that valued the startup at $2 billion . And it has a track record of intriguing successes. The biotech has focused on uncovering new connections between drugs and diseases by tapping into the vast scientific literature, among other databases. That approach identified Eli Lilly’s Olumiant as a potential Covid-19 treatment in February 2020. More recently, its scientists have built a retrieval-based language model to answer research questions — and then score and rank its own answers. In May, the team published research on tweaking AI models to boost their performance on drug repurposing tasks. But it’s also been a revolving door of leadership and strategy changes. In 2018, after the raise that valued the company at $2 billion, it hired former Google and Facebook executive Joanna Shields as CEO. Mulvany said they wanted a new leader focused more on tech than biology. “It turns out that you need to be both because you need to be in the weeds,” he said. “If you don’t understand biology, it’s hard to do product design.” Mulvany stepped down as the company’s chair in July 2021. BenevolentAI went public the following year with one of the biggest SPAC deals for a European biotech. Looking back, Mulvany said the SPAC brought in a group of biopharma investors and specialists, rather than tech-focused people. “It began to move much further away from its core strengths and what shareholders like myself and really every other shareholder had invested in, which was a tech-enabled bio company, not a bio company that had some technology in it,” Mulvany said. “It had morphed outside of what the company was meant to do.” Shields departed last fall, a few months after a much-anticipated mid-stage eczema study fell short for its then-lead drug program , which was later discontinued. Moeller, formerly the global R&D head of Leo Pharma, replaced her as CEO in January — but Mulvany’s plan to return was already in motion. In April, he published a letter to BenevolentAI’s board stating his intentions to rejoin and shake up the board. Ultimately, he and three others became directors. Since that April letter, the stock has ticked up by nearly 20%, as investors may be starting to reconsider if Mulvany has what it takes to mount an unlikely comeback. “I was very committed to re-entrenching myself in the company,” he said. “It was a very expensive and time-consuming process to get back in, but I had 100% resolve to do that.”