Akeso Inc

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.