Akeso Inc

Summit Therapeutics announced a clinical trial collaboration with Daiichi Sankyo and AstraZeneca to evaluate ivonescimab, a potential first-in-class investigational PD-1 / VEGF bispecific antibody, in combination with Datroway, a TROP2-directed antibody drug conjugate, across multiple solid tumor settings, intending to include breast and lung cancer. The companies intend to begin with a Phase III trial in first-line triple-negative breast cancer, which would expand Summit's global development program into breast cancer. Under the agreement, each company will contribute its respective therapy for the planned combination trials, which will be sponsored by AstraZeneca or Daiichi Sankyo, with all three companies contributing to trial costs and each retaining development and commercial rights to its own medicine. Datroway was discovered by Daiichi Sankyo and is jointly developed and commercialized by Daiichi Sankyo and AstraZeneca, and is one of seven DXd ADCs in Daiichi Sankyo's oncology pipeline. Ivonescimab, engineered by Akeso and known as SMT112 in Summit's license territories and AK112 outside them, has been studied in 16 Phase III clinical trials, with over 5,000 patients treated globally in clinical studies and over 100,000 in a commercial setting in China, and it is not approved by any regulatory authority in Summit's license territories, including the United States and Europe.

China's innovative drug industry has welcomed another major licensing deal. Shanghai Sprout and Merck jointly announced a global exclusive licensing agreement for SPR2015, a preclinical oral KRAS G12D (ON) inhibitor, with a potential total value of $2.13 billion, including an upfront payment of $400 million, with the remainder tied to development and commercialization milestones. Meanwhile, Summit Therapeutics, the overseas partner of Akeso, announced that AstraZeneca will make a $2 billion strategic equity investment in Summit and intends to lead clinical exploration of Akeso's first-in-class tumor immunotherapy 2.0 cornerstone drug ivonescimab in combination with AstraZeneca's Sonesitatug Vedotin for treating multiple gastrointestinal tumors. The two parties also signed a memorandum of understanding to further advance clinical exploration of ivonescimab combined with a range of AstraZeneca antibody-drug conjugates and other anti-tumor drugs. Boosted by the news, as of 10:01 a.m. on September 29, 2026, the STAR Market Biotech ETF managed by Penghua Fund, with ticker 588250, saw its underlying index, the SSE STAR Market Biomedical Index with code 000683, rise 1.10%. Among constituents, InventisBio rose 5.16%, Micro-Tech Nanjing rose 3.84%, Hotgen Biotech rose 3.13%, and Huiyu Pharmaceutical and Yound Biotechnology followed the gains. China Securities pointed out that the medical device sector has reached an inflection point in 2026, and stocks with improving performance are expected to see dual recovery in valuation and earnings. High-value consumables and in-vitro diagnostics segments are expected to gradually clear the impact of centralized procurement price cuts in the second half of the year, and leaders in niche tracks will accelerate growth.

Akeso, Inc. announced that the first patient has been enrolled in COMPASSION-37 (AK104-311), a global, multicenter Phase III head-to-head trial evaluating cadonilimab, its first-in-class PD-1/CTLA-4 bispecific antibody, plus chemotherapy versus chemotherapy with or without nivolumab as first-line treatment for HER2-negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The study is co-led by Dr. Yelena Y. Janjigian of Memorial Sloan Kettering Cancer Center, Professor Markus Möhler of Johannes Gutenberg University Mainz, Professor Jiafu Ji of Peking University Cancer Hospital & Institute, and Professor Lin Shen of Peking University Cancer Hospital. It follows the Chinese Phase III COMPASSION-15 study, which enrolled 610 patients with a notably high proportion of low PD-L1 expression at 49.8% and PD-L1-negative disease at 23%, and showed that cadonilimab plus chemotherapy significantly reduced the risk of death in the overall population regardless of PD-L1 expression status. Akeso said the trial aims to test whether dual PD-1/CTLA-4 immune checkpoint blockade can improve outcomes beyond the current standard of care, particularly for patients with low PD-L1 expression, a population for which effective immunotherapy options remain a significant global unmet need. Cadonilimab is currently approved in China for first-line gastric cancer, first-line cervical cancer, and recurrent or metastatic cervical cancer, and is being evaluated in more than 13 registrational or Phase III trials globally, two of them international multicenter studies.

Akeso announced that positive overall survival results from the Phase III HARMONi-GI1 trial of ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer have been selected as a Late-Breaking Abstract for the Presidential Symposium at the 2026 European Society for Medical Oncology Congress, to be held October 23-27 in Madrid, Spain. The company said nearly 30 clinical studies of its bispecific antibodies will be presented at the congress, including one Late-Breaking Abstract selected for the Presidential Symposium and two oral presentations. Ivonescimab, described as the world's first approved PD-1/VEGF bispecific antibody, will be featured in 12 presentations, including two rapid oral presentations on ivonescimab-based regimens as first-line treatment for advanced renal cell carcinoma and recurrent/metastatic thymic carcinoma. Cadonilimab, described as the world's first PD-1/CTLA-4 bispecific antibody, will be featured in 15 presentations covering more than ten tumor types, spanning neoadjuvant settings as well as first- and second-line treatment of advanced disease. Akeso said full results will be released during the congress.

Chinese biopharma shares rallied on Monday after a report that the U.S. Treasury Department is drafting rules that would likely allow American pharmaceutical companies to invest in promising new drugs developed by Chinese firms, excluding those related to pathogens or biotechnology that could be weaponized. Innovent Biologics rose 7% and Akeso gained 8%, while HUTCHMED advanced 3% and Sino Biopharmaceutical added 8%, and the Hang Seng Biotech Index climbed more than 5%. The report follows Friday's news of the pending Treasury rules and comes as Chinese President Xi Jinping is set to meet with his American counterpart this week, at a time when other U.S. industries face a tighter regulatory environment for business dealings in China under new national security legislation. Almost half of U.S. deals to license drugs from overseas in 2025 were with Chinese companies, and China signed licensing deals worth a total $110B in the first half of 2026.

Akeso, Inc. announced that AK158D1, its investigational next-generation bispecific antibody-drug conjugate targeting EGFR and TROP2, has secured Phase I clinical trial clearance from the Center for Drug Evaluation under China's National Medical Products Administration. The trial will assess the candidate in patients with advanced malignant solid tumors. AK158D1 is Akeso's fourth ADC to enter clinical development, joining a clinical-stage ADC portfolio that also includes AK146D1, AK138D1 and AK157D1, and it is the company's second bispecific ADC to reach the clinic. Preclinical data for AK158D1 have demonstrated potent anti-tumor activity with a favorable safety profile, supporting its potential for patients who are refractory to, intolerant of, or ineligible for existing standard of care regimens. Akeso said the candidate is designed to address the narrow tumor coverage, off-target toxicity and multidrug resistance that have constrained single-target ADCs directed against either EGFR or TROP2.

Summit Therapeutics said Sunday that its ivonescimab significantly extended survival compared with Merck's Keytruda in a late-stage lung cancer trial run by its partner Akeso in China. Ivonescimab reduced the risk of death by 27% versus Keytruda, also known as pembrolizumab, in previously untreated patients with advanced non-small cell lung cancer whose tumors expressed PD-L1, with median overall survival of 30.8 months against 22.6 months, an 8.2-month difference Summit called statistically significant. The Phase 3 HARMONi-2 trial enrolled 398 patients with a median follow-up of 36 months, and the results are being presented at the International Association for the Study of Lung Cancer's World Conference on Lung Cancer in Seoul. In the 168-patient subgroup with high PD-L1 expression, ivonescimab cut the risk of death by 42%, while the benefit was smaller and not statistically reliable in patients with lower PD-L1 expression, where the hazard ratio was 0.85 with a confidence interval crossing 1.0. Serious treatment-related adverse events occurred in 29.9% of ivonescimab patients versus 21.6% for Keytruda, though discontinuations were slightly less frequent at 4.1% versus 5%, and Summit is now recruiting for the global Phase 3 HARMONi-7 trial, expected to enroll 780 patients, while the FDA reviews a separate application in previously treated EGFR-mutated lung cancer with a Nov. 14 decision deadline.

Summit Therapeutics said its partner Akeso reported that ivonescimab monotherapy reduced the risk of death by 27% compared with pembrolizumab monotherapy in the Phase III HARMONi-2 study in PD-L1-positive advanced non-small cell lung cancer conducted in China. In the protocol-specified interim overall survival analysis, a secondary endpoint, ivonescimab achieved a hazard ratio of 0.73, with a 95% confidence interval of 0.57 to 0.95 and a p-value of 0.009, and improved median overall survival by 8.2 months, to 30.8 months versus 22.6 months for pembrolizumab. In the PD-L1 high expression subgroup, the hazard ratio was 0.58, with a 95% confidence interval of 0.38 to 0.89. The data are being presented at the IASLC 2026 World Conference on Lung Cancer in Seoul by Professor Caicun Zhou of Shanghai Pulmonary Hospital on Tuesday, September 15, 2026. Akeso received marketing authorization for ivonescimab from China's National Medical Products Administration in April 2025 based on HARMONi-2, and Summit is conducting the global Phase III HARMONi-7 study of ivonescimab monotherapy versus pembrolizumab monotherapy in PD-L1 high-expressing metastatic NSCLC, targeting enrollment of 780 patients.

Summit Therapeutics shares jumped 17.3% on Thursday after its Chinese partner Akeso reported positive overall survival results for ivonescimab in a head-to-head phase III study against Merck's Keytruda in certain non-small cell lung cancer patients. The data provides fresh clinical validation for Summit's lead oncology candidate and boosts its potential in licensed markets. Akeso's HARMONi-2 study showed ivonescimab monotherapy achieved a statistically significant improvement in overall survival versus Keytruda, meeting a key secondary endpoint. This follows earlier positive progression-free survival results with a hazard ratio of 0.51. Summit is also conducting the global HARMONi-7 study in the United States to evaluate ivonescimab against Keytruda in a similar patient population. Year to date, Summit shares have lost 2%, compared with the industry's 0.9% decline.

Summit Therapeutics noted that its partner Akeso reported positive overall survival results from the Phase III HARMONi-2 study, where ivonescimab monotherapy demonstrated a statistically significant improvement compared to pembrolizumab in patients with PD-L1-positive advanced non-small cell lung cancer. The study, conducted in China, had previously met its primary endpoint of progression-free survival with a hazard ratio of 0.51. Ivonescimab is approved in China but remains investigational in Summit's territories, including the U.S. and Europe. Summit is conducting HARMONi-7, a similar trial in patients with high PD-L1 expression.

Akeso announced that its investigational B7-H3-targeting antibody-drug conjugate AK157D1 has received clinical trial clearance from China's National Medical Products Administration. The clearance allows initiation of a Phase I study in patients with advanced malignant solid tumors, with combination development alongside Akeso's bispecific antibodies ivonescimab and cadonilimab also planned. AK157D1 is the third next-generation ADC candidate from Akeso to enter clinical development, following AK146D1 and AK138D1. Preclinical studies showed potent antitumor activity and a favorable safety profile, potentially addressing limitations of existing ADCs such as hematologic toxicity and interstitial lung disease.

Akeso secured regulatory approval in China for ivonescimab plus chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer. The company also started a new Phase II study of its bispecific ADC candidate AK146D1 in combination with ivonescimab for patients with advanced breast cancer. Akeso is a Hong Kong-based biopharmaceutical company with a HK$95.4 billion market cap focused on antibody drugs. The approval positions the ivonescimab combination as a new standard of care for advanced squamous NSCLC.

On August 13, China's A-share pharmaceutical sector strengthened, with Boji Medical and Longshen Rongfa up by the 20 percent daily limit, Fangsheng Pharmaceutical and Jiuzhou Pharmaceutical up by the 10 percent daily limit, and innovative drug companies such as Yahong Meditech, Junshi Biosciences, Dizal Pharmaceutical, and Zhongsheng Pharmaceutical rising more than 3 percent. Since WuXi AppTec released its better-than-expected 2026 interim report on August 3, the pharmaceutical sector has kept climbing, with Wanbang Pharmaceutical posting three boards in two days, Yatai Group three consecutive daily limits, and Yuyuan Pharmaceutical four boards in five days. Southwest Securities research argues that WuXi AppTec's interim net profit attributable to the parent exceeded 10 billion yuan for the first time and raised its guidance, while BeiGene, RemeGen, and Innovent Biologics released positive results at the same time, creating a sector-wide resonance effect. WuXi AppTec's first-half revenue was 28.9 billion yuan, up 38.93 percent year on year, with net profit attributable to the parent of 11.08 billion yuan, up 29.43 percent. BeiGene's first-half total revenue was 22.22 billion yuan, up 26.8 percent year on year, with net profit attributable to the parent of 3.271 billion yuan, up 627.1 percent, and it raised its full-year revenue guidance to between 44.9 billion and 46.2 billion yuan. Innovent Biologics' first-half product revenue exceeded 8.2 billion yuan, up more than 55 percent year on year. In addition, Akeso's ivonescimab injection combined with chemotherapy was approved for first-line treatment of advanced squamous non-small cell lung cancer, marking the drug's third indication in lung cancer. On August 10, China's pharmaceutical industry announced three deals, including a collaboration between BeiGene and Revolution Medicines, a partnership between Innovent Biologics and Daiichi Sankyo, and a collaboration between Gan & Lee Pharmaceuticals and Menarini, with a potential total transaction value of 726 million euros. On August 12, CSPC Pharmaceutical Group received a 30 million US dollar upfront payment from AstraZeneca. Xiangcai Securities research argues that this round of the pharmaceutical sector's rally will be significantly more durable than previous ones, based on three judgments: the pharmaceutical sector absorbing capital outflows from the technology sector, improving interim results from CXO companies, and the initial emergence of Chinese pharmaceutical companies' global expansion.

Summit Therapeutics shares traded higher after China's National Medical Products Administration approved a label expansion for ivonescimab, the lead drug developed with Akeso. The NMPA granted marketing authorization for first-line use of ivonescimab in combination with chemotherapy for advanced squamous non-small cell lung cancer, marking the third China-approved indication for the bispecific antibody. The decision was based on data from Akeso's HARMONi-6 trial, in which ivonescimab with platinum-based chemotherapy improved progression-free survival and overall survival in patients with squamous NSCLC.

Akeso announced the first patient has been dosed in a Phase II study evaluating its TROP2/Nectin-4 bispecific ADC, AK146D1, combined with its PD-1/VEGF bispecific antibody ivonescimab in advanced breast cancer. The trial focuses on first-line HR+/HER2- breast cancer and triple-negative breast cancer, aiming to explore the company's IO2.0 plus ADC2.0 strategy. Breast cancer accounts for about 2.3 million new cases annually, and Akeso believes the combination could improve efficacy while maintaining a manageable safety profile. The company is also advancing other next-generation ADC candidates and combination regimens across multiple tumor types.

The number of oral presentations on China innovative drugs at the ESMO 2026 congress has reached a record high of 47, up from 35 last year, highlighting the growing voice of China innovative drug R&D on the international academic stage. Soochow Securities noted that the global competitiveness of ADC and bispecific antibody pipelines continues to be validated, with leading players such as Hengrui Medicine, Innovent Biologics, and Akeso delivering results across multiple fronts. Data on PD-1/VEGF bispecific and trispecific antibodies will be disclosed in a concentrated manner at this year's ESMO. In addition, the 12th round of national centralized drug procurement has officially launched, covering 65 varieties, with on-site bidding in Shanghai on July 31 and a procurement cycle through the end of 2029. The Sci-Tech Innovation Board Biopharma ETF Harvest Fund tracks the Shanghai Stock Exchange STAR Board Biomedical Index, which selects 50 large-cap biomedical industry leaders from the STAR Board, with the top ten constituents accounting for 51.84% of the total weight.

Summit Therapeutics reported a second-quarter 2026 loss per share of 28 cents, wider than the Zacks Consensus Estimate of a loss of 26 cents per share, while the company had no revenue as it lacks a marketed product. Research and development expenses fell 24.2% year over year to $157.7 million, and general and administrative expenses plunged 82.6% to $62.8 million, driven by a significant reduction in stock-based compensation, though total operating expenses rose 13% sequentially on higher ivonescimab spending. Cash, cash equivalents and short-term investments stood at $690.7 million as of June 30, 2026, up from $598.7 million at the end of March, after Summit raised $230.8 million in gross proceeds through its at-the-market facility during the quarter and an additional $68.4 million after quarter-end. The lead pipeline candidate, ivonescimab, a dual PD-1/VEGF inhibitor being developed with China-based Akeso, is under FDA review with a decision expected by November 14, 2026 for EGFR-mutant non-small cell lung cancer, and updated overall survival data from the HARMONi study showed a consistent hazard ratio of 0.76 across Western and Asian subgroups. Summit is also running three late-stage studies—HARMONi-3 in first-line metastatic NSCLC, HARMONi-7 in first-line metastatic NSCLC with high PD-L1 expression, and HARMONi-GI3 in first-line metastatic colorectal cancer—and recently announced a collaboration with Arcus Biosciences to evaluate casdatifan plus ivonescimab in clear cell renal cell carcinoma, with initial data expected by mid-2027.

Akeso, Inc. has dosed the first patient in a Phase II clinical study evaluating its novel TROP2/Nectin-4 bispecific antibody-drug conjugate AK146D1 in combination with its PD-1/VEGF bispecific antibody Ivonescimab for advanced non-small cell lung cancer. The trial, designated AK146D1-201, focuses on the first-line treatment setting and is part of the company's broader IO2.0 plus ADC2.0 strategy. Akeso notes that Ivonescimab has shown transformative benefits over PD-1 inhibitor-based therapies in multiple Phase III studies, while AK146D1 has demonstrated potent antitumor activity with a favorable safety profile. The company's pipeline also includes next-generation ADC candidates such as the HER3-targeting AK138D1 in Phase I, the early clinical-stage AK157D1, and the bispecific ADC AK158D1. Akeso's stock closed Monday at HKD 93.35, up 5.66%, and has traded between HKD 80.20 and HKD 179.00 over the past year.

Akeso's CD47-targeting antibody Ligufalimab, combined with azacitidine and venetoclax, demonstrated meaningful survival and response improvements in treatment-naïve acute myeloid leukemia patients in a Phase II trial. The randomized, double-blind, placebo-controlled study showed a median event-free survival of 9.1 months for the Ligufalimab arm versus 6.9 months for control, with a hazard ratio of 0.46. Median overall survival was not reached in the Ligufalimab group compared with 8.3 months in the control group, and the objective response rate was 80% versus 66.7%. The safety profile was consistent with standard AML therapy, with no new safety signals identified. Ligufalimab has received Orphan Drug Designation from the U.S. FDA for AML and is the first anti-CD47 monoclonal antibody to enter a registrational Phase III trial in solid tumors.