Akeso Biopharma Co., Ltd.

Created with Canva Dreamlab † Leading companies spent $1.4 billion upfront on licensing deals and embarked on vast R&D programs. Clinical setbacks mean many companies are unlikely to ever recoup their investments. TIGIT was once the hottest target in immuno-oncology. Just a few years later, the pipeline has thinned significantly as a who’s who of drugmakers have retreated from the mechanism in response to lackluster clinical data. Some R&D programs are ongoing, but the rapid retreat means the industry has already burnt billions of dollars on deals and development for failed candidates. Bristol Myers Squibb , Gilead, GSK and Novartis paid $1.4 billion upfront between them to join Merck and Roche in the TIGIT race. The figure excludes the $175 million Gilead paid to enter into a multi-asset deal that gave it the right to license candidates including Arcus Biosciences’ domvanalimab, but includes the $275 million the big biotech handed over when it took up its option on the anti-TIGIT antibody. The deals collectively included more than $5 billion in milestones. However, the overwhelming majority of them were unpaid when BMS, GSK and Novartis dropped their TIGIT programs. Gilead is still developing its asset and could owe Arcus up to $500 million in milestones tied to approvals in the U.S. Even without the regulatory milestones, Gilead has bet more on TIGIT than some of its peers. The outlay includes $740 million in equity investments in Arcus. Gilead paid an average of $27.58 per share across the three purchases. Arcus currently trades below $10. The fate of domvanalimab will go a long way in determining what return, if any, Gilead gets on its investment in Arcus. TIGIT Development Costs TIGIT development costs are embedded in the vast R&D budgets of the biopharma companies advancing the candidates. Roche’s broad tiragolumab development program accounted for some of the almost $15 billion the Swiss drugmaker spent on R&D last year, but publicly available figures lack details of the company’s spending on TIGIT. Similarly opaque accounts obscure TIGIT spending at other companies. Programs partnered with smaller biotechs shed some light on TIGIT development costs. GSK and iTeos Therapeutics agreed to spend $900 million on the global development plan for their TIGIT drug. The asset’s failure in Phase II means GSK and iTeos likely only spent a fraction of that amount, but the figure provides a ballpark estimate of what companies with large late-phase programs may have invested. Roche has tested tiragolumab in 10 Phase III studies with a collective enrollment target of almost 4,600 patients. Merck’s Phase III vibostolimab program spanned five studies with a collective enrollment target of more than 4,600 patients. Gilead, Arcus and AstraZeneca, which is partnered on a domvanalimab trial, have sponsored three Phase III studies that are enrolling almost 3,000 patients among them. If GSK and iTeos’ spending plan is indicative of R&D costs at other companies, Gilead, Merck and Roche may have spent billions of dollars between them taking their TIGIT assets through mid- and late-phase trials. Gilead’s relationship with Arcus provides another datapoint. Arcus received between $161 million and $165 million from its collaboration partners as reimbursement for R&D costs in 2022, 2023 and 2024. Mechanisms other than TIGIT will account for some of the spending. Equally, the figures do not capture spending on Gilead-led activities, which Arcus said increased in 2024. ITeos’ accounts provide another glimpse at the cost of TIGIT development. As of the end of March, the biotech had raised more than $1.1 billion across public and private financing rounds and its deal with GSK. ITeos, which is closing down over its TIGIT flop, had $624 million in cash and investments. The difference between the amount iTeos had raised and the amount it was holding was more than $500 million. A History of Failed Oncology Bets Spending on TIGIT adds to the mountain of money that drug developers have plowed into an alphabet soup of targets that at one time were seen as the next big thing in cancer immunotherapy. IL-2 attracted interest in 2018 and 2019, when BMS paid Nektar Therapeutics $1.85 billion to co-develop a molecule and Sanofi acquired Synthorx for $2.5 billion. Both programs ended in failure. Other companies placed bets on CD47. Gilead acquired Forty Seven for $4.9 billion in 2020 and Pfizer snapped up Trillium Therapeutics for $2.3 billion the following year. Pfizer continues to list maplirpacept, a CD47 candidate acquired in the Trillium takeover, in its pipeline, but Gilead’s travails have dampened expectations. Gilead gave up on Forty Seven’s magrolimab last year after a series of setbacks. TIM-3, 4-1BB, ICOS, OX40 and CD73 are among the other targets that have attracted heavy investment, including triple-digit upfront licensing fees, over the years. Active clinical development is continuing in some areas but the targets are yet to live up to the early excitement, such as the report that 4-1BB drug candidates were driving “pretty phenomenal responses” in cancer patients. Work on LAG-3 delivered an approved drug, BMS’ Opdualag, but sales have been fairly modest by the standards of leading immuno-oncology products. Opdualag, a fixed-dose combination of PD-1 and LAG-3 blockers, generated sales of $928 million last year. BMS is on course to reach the blockbuster threshold this year, with sales in the first quarter coming in at $252 million. As excitement about TIGIT and the other targets has faded, PD-1/L1xVEGF-A bispecifics have emerged as the industry’s next big hope. With China’s Akeso validating the mechanism, albeit without allaying concerns about overall survival and efficacy in global trials , leading biopharma companies have moved swiftly to secure riders in immuno-oncology’s new hottest race. In the nine months since Akeso’s ivonescimab beat Keytruda, BioNTech, BMS, Merck and Pfizer have paid more than $4 billion upfront among them for rights to PD-1/L1xVEGF-A bispecifics. The outlay will rise by at least $2 billion as BMS makes noncontingent payments and could top $20 billion if the deals hit their milestones. The fallout from failure would make the TIGIT turmoil look like a tempest in a teapot.

HONG KONG, June 15, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") presented the subgroup analysis data from the Phase III COMPASSION-16 trial, evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody, in the first-line treatment of advanced, recurrent, or metastatic cervical cancer. The data was featured as an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The subgroup analysis demonstrated that cadonilimab treatment significantly improved progression-free survival (PFS) and overall survival (OS) across different patient subgroups, including: levels of PD-L1 expression, prior treatment with concurrent chemoradiotherapy (CCRT), bevacizumab use, and age of the patients (≥65, <65). These results further demonstrate the clinical value and the global women's health impact of cadonilimab in advancing thetreatment standart for advanced cervical cancer. The results of the COMPASSION-16 study were previously published in The Lancet and presented at the 2024 International Gynecologic Cancer Society (IGCS) Global Meeting. The Lancet publication and the IGCS presentation disclosed that cadonilimab, in combination with platinum-based chemotherapy (with or without bevacizumab), significantly extended survival in both PD-L1-positive and PD-L1-negative patient populations (mOS HR 0.64, P=0.0011), and reduced the risk of disease progression and death (mPFS HR 0.62, P<0.0001). At the 2025 ASCO annual meeting, the study's principal investigator, Professor Xiaohua Wu from the Fudan University Shanghai Cancer Center, presented the subgroup analysis findings from the COMPASSION-16 study, with data cut-off as of April 30, 2024. Key Findings: Significant Reduction in Mortality Risk Across All Patient Subgroups, Regardless of PD-L1 Expression: In the CPS<1 group, mPFS was 12 months in the cadonilimab arm vs. 8.2 months in the control arm (HR=0.65), and mOS was not reached in the cadonilimab arm vs. 25.3 months in the control arm (HR=0.77). In the CPS≥1 group, mPFS was 14.7 months in the cadonilimab arm vs. 8.3 months in the control arm (HR=0.62), and mOS was not reached in the cadonilimab arm vs. 22.7 months in the control arm (HR=0.69). In the CPS≥10 group, mPFS was 17.1 months in the cadonilimab arm vs. 8.1 months in the control arm (HR=0.54), and mOS was not reached in the cadonimab arm vs. 29 months in the control arm (HR=0.68). Clinical Benefit in PFS and OS Regardless of Prior CCRT Treatment: In patients previously treated with CCRT, mPFS was 16.1 months in the cadonilimab arm vs. 7.9 months in the control arm (HR=0.55), and mOS was not reached in the cadonilimab arm vs. 22.8 months in the control arm (HR=0.54). Clinical Benefit in PFS and OS Regardless of Bevacizumab Use: In real-world settings, approximately 40% of patients are considered unsuitable for bevacizumab due to underlying conditions or bleeding/perforation risks. Cadonilimab demonstrated clinically meaningful improvements in both PFS and OS, whether or not bevacizumab was included in the treatment. In the bevacizumab-naive groups, mPFS was 11.7 months in the cadonilimab arm vs. 6.7 months in the control arm (HR=0.44), and mOS was 28.2 months in the cadonilimab arm vs. 15.1 months in the control arm (HR=0.5). Improvement in PFS and OS Across Age Subgroups, with Greater Efficacy in Patients ≥65 Years: In patients < 65 years, mPFS was 13.5 months in the cadonilimab arm vs. 9.5 months in the control arm (HR=0.68), and mOS was not reached in the cadonilimab arm vs. 25.3 months in the control arm (HR=0.69). In patients ≥ 65 years, mPFS was 12 months in the cadonilimab arm vs. 7.4 months in the control arm(HR=0.39), and mOS was 26.6 months in the cadonilimab arm vs. 15.1 months in the control arm (HR=0.49). Cadonilimab Combined with Platinum Agents (Cisplatin/Carboplatin) Improves PFS and OS: In the cisplatin arm, mPFS was 14.7 months in the cadonilimab arm vs. 8.1 months in the control arm (HR=0.49), and mOS was not reached in the cadonilimab arm vs. 23.9 months in the control arm (HR=0.43). In the carboplatin arm, mPFS was 12 months in the cadonilimab arm vs. 8.2 months in the control arm (HR=0.72), and mOS was 27.8 months in the cadonilimab arm vs. 22.8 months in the control arm (HR=0.82). In June 2022, cadonilimab was granted approval by the China National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer in patients who had previously failed platinum-based chemotherapy. This indication has since been included in the national reimbursement list. In September 2024, the use of cadonilimab in first-line treatment for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma was approved by the NMPA. The use of cadonilimab in first-line treatment for advanced, recurrent, or metastatic cervical cancer was approved by the NMPA in May 2025. In addition, cadonilimab is currently being evaluated in nearly 30 registrational/Phase III and Phase II clinical trials across a number of high-incidence cancers. Preliminary results show that cadonilimab demonstrates clinical benefit for patient populationsin both the positive and the negative PD-L1 expression groups, marking a significant advancement over existing immunotherapies. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. ( 9926.HK, "Akeso") contains "forward-looking statements" . These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Pfizer’s due diligence process involved people from Bourla down and boots on the ground in China.\n Pfizer CEO Albert Bourla has pulled back the curtain on his $1.25 billion bet on a PD-1xVEGF bispecific, revealing that his team went through individual scans and interviewed investigators to gain reassurance about the quality of the Chinese data.The question of whether promising data generated at Chinese sites will hold up in global trials has hung over the PD-1/L1xVEGF sector since Summit Therapeutics and Akeso’s ivonescimab beat Merck & Co.’s blockbuster oncology drug Keytruda in a head-to-head study last year. Despite the doubts, companies have bet billions on assets in recent months.Pfizer joined the race last month by paying 3SBio $1.25 billion upfront for ex-China rights to SSGJ-707. Speaking at a Goldman Sachs event Monday, Bourla said (PDF) 3SBio’s data looked “very good” but “of course they were data in China.”The Chinese origins of the data meant Pfizer wanted to get to know 3SBio and be “very careful” with due diligence, Bourla said. Pfizer’s due diligence process involved people from Bourla down and boots on the ground in China. “We sent teams [to] China. They spent weeks. They went to the sites. They viewed the scans one after the other. They interviewed the physicians that [ran] the study,” Bourla said. “We didn\'t do due diligence in a data room. We sent people on-site. We feel very comfortable. I met the CEO. They are credible guys.”Asked by an analyst about the size of the deal, Bourla said Pfizer will only pay the full $6 billion “if the whole thing is very successful and sells a lot.” The comment suggests some payments are tied to sizable sales milestones but, even at the current level, the deal is a significant outlay on a single investigational asset.Pfizer sees SSGJ-707 as a strategic asset because of its potential to displace PD-1/L1 checkpoint inhibitors and combine with its portfolio of antibody-drug conjugates (ADCs). The portfolio, the core of which came to Pfizer in the Seagen takeover, features ADCs that use vedotin as a payload. The vedotin-based Pacdev and Keytruda work well together. Pfizer is betting SSGJ-707 will also pair nicely with its vedotin ADCs.“Vedotin has been proven that, because it creates immunogenic cell death, it has synergistic effects with PD-1s,” Bourla said. “For us to have the new, let\'s say, standard of immunotherapy as part of our portfolio is very strategically important given that we have all the ADCs.” The potential for SSGJ-707 to enhance ADCs led Pfizer to pick up the asset despite the company having bigger gaps in other parts of its portfolio. Bourla said the bar for Pfizer striking a deal in oncology “is much higher” than in other therapeutic areas “because we have plenty of assets.”Pfizer is looking at obesity assets, Bourla said. The company axed an asset in April after seeing a potential drug-induced liver injury, sparking speculation that it would buy itself back into the race. Pfizer sees “a lot of risk with pricing” in obesity, Bourla said, and is considering lower prices in its calculations of asset value. With Bourla saying premiums are “very, very high,” Pfizer is staying on the sidelines for now.“We are not going to overpay. And, right now, there are a lot of crazy demands,” Bourla said.