Sacituzumab tirumotecan

iStock, Khafizh Amrullah In its latest five-year plan, China has set its sights on developing five drugs that could each rake in more than $1 billion globally by 2030. Experts say it’s well on its way, with two medications having already met that bar. Crucial to China’s goal of becoming a global biopharma juggernaut by 2030 is delivering at least five domestically developed blockbuster drugs with global sales topping $1 billion annually. Experts tell BioSpace that the Asian giant is already well on its way to hitting this target. “Two have already crossed the [blockbuster] threshold,” Mark Lansdell, director at the life sciences intelligence firm Evaluate, told BioSpace in an email. And according to Evaluate data, at least four more are forecast to follow. The industry considers products that make $1 billion in annual sales to be blockbuster drugs. Indeed, BeOne Medicines’ BTK blocker Brukinsa, first approved in late 2019 for mantle cell lymphoma, brought in $3.9 billion last year across what has become a broad range of indications. Meanwhile, Legend Biotech’s Johnson & Johnson partnered CAR T therapy Carvykti, indicated for relapsed or refractory multiple myeloma, hit $1.89 billion last year. Next up is likely to be Guangdong-based Akeso’s ivonescimab, on which the company has partnered with Summit Therapeutics and is expecting an initial FDA approval as early as November . Evaluate expects the PD-1xVEGF to hit $4.4 billion in sales by 2030 across several indications, according to Lansdell. Beyond Brukinsa, Carvykti and ivonescimab, Evaluate projects four other Chinese-developed medicines will bring in at least $1 billion yearly by 2030. Below, BioSpace takes a closer look at the products that could help the Asian giant hit the bold five-year goal and solidify its position as a global biopharma behemoth. China China plans to transform biotech sector into $522B powerhouse by 2030 A new five-year biotech plan has been released by the Chinese government, revealing ambitious goals such as achieving five blockbuster medicines on the global markets in that time. September 18, 2026 · 2 min read · Annalee Armstrong Read more BeOne’s Brukinsa, already a blockbuster, poised for expansion Topping Evaluate’s list is BeOne’s BTK inhibitor Brukinsa , which is approved for a wide range of cancers, including mantle cell lymphoma, chronic lymphocytic leukemia and Waldenström’s macroglobulinemia. Brukinsa already crossed the blockbuster bar, surging 49% year-on-year in 2025 to bring in $3.9 billion. The drug has continued to grow, with a 31% increase in Q2 sales to hit $1.2 billion. Evaluate forecasts the drug to reach $6.5 billion in annual global sales by 2030, according to data provided by Lansdell. BeOne continues to study Brukinsa in other indications, including treatment-naive mantle cell lymphoma. Phase 3 data in June showed that Brukinsa plus the anti-CD20 antibody rituximab met the primary endpoint of progression-free survival in the Phase 3 MANGROVE study, reducing the risk of progression or death by 43% versus rituximab plus chemotherapy. A regulatory submission in this indication is slated for this year. The company is also working to expand Brukinsa into marginal zone lymphoma and primary membranous nephropathy. Legend Biotech’s J&J-partnered Carvykti faces potential competitive headwinds Also already past the blockbuster line is the CAR T therapy Carvykti, originally developed by Legend Biotech, which was founded in 2015 as a subsidiary of the Nanjing-based contract developer GenScript. In 2017, Legend scored a powerhouse partner in J&J, which fronted $350 million to work with the Chinese company to advance an anti-BCMA CAR T therapy that, in February 2022, would ultimately win the FDA’s go-ahead and hit the market as Carvykti. The multiple myeloma therapy made blockbuster status last year, bringing in $1.89 billion worldwide —nearly double its 2024 sales. And Carvykti continues to climb, already surpassing full-year 2025 sales in the first nine months of this year with $1.96 billion, according to J&J’s most recent earnings report. But there are some competitive headwinds on the horizon. By Dec. 23 , the FDA is scheduled to release a verdict for Gilead’s anitocabtagene autoleucel (anito-cel), another CAR T therapy that is being proposed for relapsed or refractory multiple myeloma. While the potential approval will be for fourth-line or later use, falling outside Carvykti’s established position in the second-line setting , Gilead plans to push anito-cel earlier, with a second-line filing ready as early as next year, the pharma said in its third quarter report . Legend and J&J are continuing to test Carvykti as a frontline option for multiple myeloma. Summit lines up ivonescimab as next major cancer backbone Ivonescimab has emerged as one of the leading candidates for China’s blockbuster aspirations. The drug—originally developed by Guangdong-based Akeso and being tested globally in partnership with Summit Therapeutics—first captured the industry’s attention in September 2024 when it beat Merck’s mega-blockbuster therapy Keytruda in a head-to-head late-stage non-small cell lung cancer study. And while there have been some hiccups, including an overall survival miss in a Phase 3 global study in May last year, analysts still expect that ivonescimab could be a commercial powerhouse. Other cancer drugmakers appear to agree, with AstraZeneca, Pfizer and more teaming up with Summit to pair their own assets into ivonescimab combos. “If the data do pan out, then simply put, ivonescimab has the potential to replace Keytruda as the next major backbone of treatment in cancer—and in turn, to become the next best-selling oncology drug of all time,” Graig Suvannavejh, managing director and senior biotech and biopharma analyst at Mizuho Securities, told BioSpace . Evaluate has estimated that ivonescimab could grow to an estimated $4.4 billion in global sales by 2030. Cancer Drugmakers rush to pair up with Summit’s ivonescimab ahead of key verdict With companies including AstraZeneca, Pfizer and Revolution Medicines clamoring to get in on Summit Therapeutics’ Akeso-partnered PD-1xVEGF antibody, one analyst calls the asset “the next major backbone” of cancer treatment. November 2, 2026 · 6 min read · Tristan Manalac Read more BeOne’s Tevimbra set for blockbuster status as early as 2027 BeOne’s second appearance on this list is for the PD-1 inhibitor Tevimbra, which according to Evaluate’s Lansdell is “forecast to pass $1 billion in annual sales as early as 2027.” First approved by the FDA in March 2024 for esophageal squamous cell carcinoma, Tevimbra has since expanded into gastroesophageal adenocarcinoma. In the European Union, Tevimbra is also indicated for non-small cell lung cancer, small cell lung cancer and nasopharyngeal carcinoma. Across these indications, the drug last year jumped 19% from 2024 to earn $737 million globally. Tevimbra continues to trend upward, making $229 million in the second quarter, an 18% year-on-year increase—and a roughly 7% beat versus analyst expectations, according to an Aug. 6 note from Leerink Partners. BeOne in August announced that the FDA approved the first-line use of Tevimbra, alongside Jazz Pharmaceuticals and Zymeworks’ anti-HER2 bispecific Ziihera, for advanced HER2+ gastric, gastroesophageal junction or esophageal adenocarcinoma. In a Jan. 6 note, Leerink said the Tevimbra-Ziihera combo was “clearly practice-changing” in this indication. BeOne is also developing Tevimbra for urothelial bladder carcinoma and is working on a subcutaneous formulation for the drug. Both are in late-stage development. Kelun-Biotech and Merck aim to replace chemo in NSCLC with Sac-TMT Another Big Pharma–partnered asset on this list is sacituzumab tirumotecan (sac-TMT), an antibody-drug conjugate (ADC) that was originally developed by Chengdu-based Kelun-Biotech. Merck in December 2022 paid $175 million upfront —and gambled up to $9.3 billion in milestones—for an exclusive global license to the asset and six other Kelun ADCs outside mainland China, Hong Kong and Macau. Sac-TMT is currently being studied for several cancer types, including non-small cell lung cancer (NSCLC), bladder cancer, breast cancer and gastric cancer. Early Phase 3 NSCLC data presented in July showed that sac-TMT plus Merck’s blockbuster drug Keytruda improved progression-free survival and showed a positive overall survival trend versus Keytruda plus chemotherapy. These findings suggest that sac-TMT could replace platinum-based chemotherapy as a first-line NSCLC treatment option. Merck also presented data last month at the 2026 European Society for Medical Oncology (ESMO) meeting in Madrid showing that sac-TMT slashed the risk of death by 32% in a late-stage trial of endometrial cancer. Based on these results, the FDA accepted Merck’s application for approval of sac-TMT in this indication and granted priority review. In December 2025, the FDA awarded sac-TMT a Commissioner’s National Priority Voucher , which can shorten review times from the typical 10–12 months to just 1–2 months. However, Leerink Partners analysts have noted that “it’s unclear to us whether the CNPV is still active after Commissioner Makary’s departure from FDA.” Still, the group said, Merck “is in discussions with the FDA and is hopeful for an earlier approval.” Assuming U.S. approval and launch next year, Evaluate’s Lansdell projects sac-TMT to cross the blockbuster bar in 2029 and hit $2 billion in sales by 2030. The ADC is already approved in China for various types of breast cancer, but Kelun has yet to provide sales numbers. Hansoh’s Ameile nears blockbuster status even without US approval Another likely Chinese blockbuster is Hansoh Pharma’s Ameile, which first hit the global biopharma markets in 2020 after being approved in China for second-line treatment of patients with advanced NSCLC carrying the T790M EGFR mutation. The drug has since expanded into other NSCLC types and treatment settings in the Asian country. Ameile is also approved outside China. In June 2025, the U.K.’s Medicines and Healthcare products Regulatory Agency greenlit the drug under the brand name Aumseqa, opening up use for certain NSCLC patients. The European Union in February likewise gave the go-ahead for Aumseqa, but walked back this decision in September after a legal challenge from AstraZeneca alleged that the regulatory submission for Hansoh’s drug violated data protection policies. Hansoh resubmitted the application last month. There is no ongoing application for Ameile, also known as aumolertinib, in the U.S. Despite the EU setback, Lansdell said Evaluate continues to project that Ameile will hit blockbuster status by 2030, though he didn’t provide a specific sales forecast for the drug. In its annual 2025 and interim 2026 reports, Hansoh provided no sales figures for Amelie, but according to a September analysis by analytic and content platform VCBeat, Ameile made RMB 5.53 billion ($830 million) last year, making it the top-selling innovative drug in China.