Rusfertide acetate

AstraZeneca's $15 billion pledge to China, Boehringer and Simcere's IBD deal, and a more complicated ADC market dynamic made our news this week. AstraZeneca made a big commitment to China as CEO Pascal Soriot joined British Prime Minister Keir Starmer on a trip to the country. Boehringer Ingelheim secured a preclinical inflammatory bowel disease bispecific from Simcere. Daiichi Sankyo's U.S. chief talked about the success—and challenges—the company is seeing with Enhertu and Datroway. And more.1. AstraZeneca vows $15B China investment to boost cell therapy and radioconjugate capabilitiesAstraZeneca said it will invest $15 billion in China through 2030 to expand drug manufacturing and R&D. The company highlighted cell therapy and radioconjugates as targeted areas for investment. The announcement was made as AZ CEO Pascal Soriot joined British Prime Minister Keir Starmer’s delegation of more than 50 representatives on a state visit to China. GSK’s board chair Jonathan Symonds and Haleon CEO Brian McNamara were also on the delegation.2. AstraZeneca returns to China's CSPC for $18.5B obesity dealRight on the heels of the investment pledge, AZ on Friday unveiled a deal worth up to $18.5 billion with China's CSPC Pharmaceuticals for the ex-China rights to the biopharma’s once-monthly injectable weight management portfolio of eight programs. The deal features $1.2 billion in upfront cash.3. Boehringer pens €1.05B deal for Simcere's preclinical IBD bispecificMeanwhile, Boehringer Ingelheim has obtained ex-China rights to a preclinical inflammatory bowel disease bispecific antibody from Simcere. The drug targets TL1A and IL-23p19 and has “demonstrated superior synergistic efficacy, even outperforming the combination of the two corresponding monotherapies” in preclinical studies, Boehringer said. The deal could be worth up to 1.05 billion euros.4. Daiichi Sankyo navigates complexity of success as Enhertu, Datroway push for market dominanceAs Enhertu moves to earlier lines of treatment, Daiichi Sankyo is dealing with some nuanced treatment questions that could affect the star antibody-drug conjugate’s revenue outlook. These include how long the drug should be used in first-line breast cancer and whether it’s suitable for continuous neoadjuvant-plus-adjuvant treatment in early-stage disease. It all comes as Datroway faces increased competition in the TROP2 space.5. Takeda, still in a Vyvanse slog, lifts guidance as it looks to new wave of growthDuring the nine months ended Dec. 31, Takeda generated revenue of 3.4 trillion Japanese yen ($22.3 billion), down 3.3% year over year, no thanks to generic erosion of Vyvanse. However, the gap between the Vyvanse decline and growth from new meds is narrowing. Looking to its next wave of growth, Takeda is preparing for the launches of narcolepsy med oveporexton and polycythemia vera treatment rusfertide.6.  Qilu programs path into cardiometabolic disease with $120M, AI-enabled Insilico allianceInsilico Medicines has signed another partner for its artificial intelligence drug discovery platform. This time, Qilu Pharmaceutical is offering up to $120 million to collaborate on small molecules for treating cardiometabolic diseases. Insilico will be responsible for designing and optimizing the molecules, while Qilu will handle development and commercialization.7. Formation Bio’s China shopping spree continues with $500M biobucks autoimmune pactFormation Bio’s newly created subsidiary Kenmare Bio is gaining ex-China rights to a miR-124 activator from China’s Jiangsu Chia Tai Feng Hai Pharmaceutical in a deal worth up to $500 million. The Formation unit will use its AI capabilities to accelerate the drug’s development “in a range of autoimmune diseases.” Sino Biopharmaceutical’s Chia Tai Feng Hai has studied the drug in preclinical models for ulcerative colitis.Other News of Note: 8. China regulators suspend sale of Sun Pharma's dementia med after site inspection9. Lisata reclaims China rights to solid tumor candidate ahead of acquisition10. ST Pharm inks $56M deal to produce API for a US biotech11. FDA sets decision date for Summit’s PD-1xVEGF bid (regulatory tracker)12. Elevar refiles Hengrui-partnered PD-1 combo with FDA in first-line liver cancer (release)

Takeda reported a sales decline of 3.3% for the nine months ending on Dec. 31 compared with the same period in 2024. Quarter after quarter for the past year, Takeda’s revenues have been bogged down by generic impacts to its stalwart ADHD med Vyvanse. Now that the gap between Vyvanse erosion and growth from new products is narrowing, Takeda is eager to move into its next chapter.Still, another threat may be on the horizon for Takeda with the release of the latest batch of drugs up for Inflation Reduction Act (IRA) price cuts.Takeda is nearing the end of its 2025 fiscal year under the Japanese financial calendar, which ends in March 2026. In the nine months ending on Dec. 31, the company garnered revenue of 3.4 trillion yen ($22.3 billion), down 3.3% from the same period in 2024.Takeda's 2025 financial year has been expected to be the final year of major generic headwinds to Vyvanse, the company said in July, although it had previously said the same about its 2024 expectations. Still, the company has new hopes for fiscal 2025, as underscored by its updated forecast for full-year revenues. Previously, Takeda expected 4.5 trillion yen ($29.4 billion), but it's now looking to collect 4.53 trillion yen ($29.6 billion).   The company’s top earner remains its inflammatory bowel disease (IBD) med Entyvio, which brought in 744.5 billion yen ($4.9 billion) in the nine-month period, good for 7.4% growth year-over-year growth. Entyvio fits into Takeda’s collection of growth products spread across six therapeutic areas, which together contributed 52% of its total revenue over the period, or 1.8 trillion yen ($11.3 billion) combined. These growth drivers are helping to fill in the gap that off-patent products, namely Vyvanse, left with their 45.7% revenue declines, the company laid out in its presentation (PDF). “With each quarter, the gap is becoming smaller as the Vyvanse decline was heavily weighted to the first half of the year, and the growth and launch products are performing better in the second half,” chief financial officer Milano Furuta explained on a conference call. Other growth products will soon join Entyvio as the company prepares for “multiple innovative launches” within this “truly pivotal year for Takeda,” Furuta commented in the company’s press release.These new launches include a narcolepsy med called oveporexton and a polycythemia vera treatment called rusfertide, both of which are expected to roll out in the second half of 2026. Takeda’s upcoming psoriasis med, zasocitinib, meanwhile, has an anticipated debut timeline in 2027. These three new drugs are expected to put Takeda on a “new growth trajectory,” the company noted in the presentation.Although it hasn’t yet disclosed peak revenue projections for the products, the company believes that the trio could “more than offset” the anticipated impact of biosimilar competition to top growth driver, Entyvio, in the next decade, CEO Christophe Weber said. Those launches will fall under the domain of incoming CEO Julie Kim, who is set to formally take over from Weber in June. The transition comes 12 years after Weber first took the helm in 2014, marking a significant new chapter for the company as it moves into the latter half of the decade. Kim came to Takeda in 2019 with its $62 billion acquisition of Shire and most recently served as president of the company’s U.S. operations.“One of the benefits of being an internal successor is that we don't have to slow down,” Kim said on the company’s earnings call, which was the last to be led by Weber. “We can keep the momentum going and continue to move the organization forward.”U.S. policy impacts Kim is stepping into the CEO role as the industry grapples with changing U.S. pharma policies from the Trump administration. Although Takeda was excluded from President Trump’s requests to comply with his Most Favored Nation (MFN) drug pricing mechanism, the company has been outspoken with its MFN-related criticisms. The MFN strategy generally aims to align U.S. prices with those in other developed countries.“MFN is not an approach that we support,” Kim said on the call. “Having price controls and importing one component of healthcare systems that have very, very different structures does not make sense for the U.S. and can impact future innovation.” Even so, the company is putting a focus on the U.S. market with newly announced organizational changes that set up an International Business Unit to oversee all markets outside of the U.S. Creating two geographic focuses is “part of being able to set ourselves up for success going forward,” Kim explained.One U.S. policy that will impact Takeda is the IRA. Earlier this week, the Centers for Medicare & Medicaid Services (CMS) unveiled the next 15 medicines that will be up for Medicare price cuts to take effect in 2028. Entyvio’s inclusion on the list is something the company had already been preparing for, according to Kim. Although it remains to be seen how the negotiation will turn out, the incoming CEO pointed out that the last round of IRA price cuts resulted in steeper reductions than the first.