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In the first half of 2026, global pharmaceutical R&D achieved significant progress across multiple fields. Entering the second half of the year, several drugs in critical stages of regulatory review warrant close attention. This article outlines five of the most representative milestone events, covering areas such as targeted therapy for lung cancer, bispecific antibodies, novel-mechanism drugs for ADHD, and treatments for kidney disease.I. Zidesamtinib (NVL-520) and Neladalkib (NVL-655)
Developer: Nuvalent (acquired by GSK for $10.6 billion in June 2026)Indications: ROS1-positive non-small cell lung cancer / ALK-positive non-small cell lung cancerReview Milestones: September 18, 2026 (Zidesamtinib); November 27, 2026 (Neladalkib)In June 2026, GSK acquired Nuvalent for $10.6 billion ($124 per share in cash, representing a 40% premium), marking one of the largest deals in the biopharmaceutical sector in the first half of the year. The core assets underpinning GSK’s bet are precisely these two next-generation targeted therapies for lung cancer, which are poised to enter FDA review.Neladalkib (an ALK inhibitor) and Zidesamtinib (a ROS1 inhibitor) are both brain-penetrant selective inhibitors, sharing three core characteristics: First, they are designed to retain activity in tumors that have developed resistance to existing inhibitors (including first-, second-, and third-generation agents), covering treatment-related mutations such as ALK G1202R and ROS1 G2032R. Second, they possess central nervous system (CNS) penetrance to improve therapeutic options for patients with brain metastases. Third, they avoid inhibiting the structurally related tropomyosin receptor kinase (TRK) family, thereby circumventing the CNS adverse events commonly associated with dual inhibitors. Both agents aim to drive deep and durable responses in patients across all lines of therapy.Both drugs have received FDA Breakthrough Therapy Designation and Orphan Drug Status.Zidesamtinib
Key data were presented at the 2025 IASLC World Conference on Lung Cancer. Among 117 patients previously treated with ROS1-TKIs, the objective response rate (ORR) was 44%, and the duration of response (DoR) was 78% and 62% at 12 and 18 months, respectively. In a subgroup of 55 patients who had received one prior ROS1-TKI (crizotinib or entrectinib), the ORR was 51%, and the DoR at both 12 and 18 months was 93%. The drug demonstrated clear efficacy in patients with brain metastases and effectively inhibited the ROS1 G2032R resistance mutation. Regarding safety, only 10% of patients required dose reduction, and 2% discontinued treatment due to adverse events. Its design selectively targets ROS1 while sparing TRK activity, thereby reducing the risk of neurotoxicity.Neladalkib
Results from the ALKOVE-1 study showed that among 253 evaluable patients who had previously received TKI therapy, the overall objective response rate (ORR) was 31%. Among responders, 64% maintained a duration of response exceeding 12 months, and 53% exceeded 18 months. The drug effectively overcame the G1202R resistance mutation, with an intracranial overall response rate (IC-ORR) of 32% in patients with brain metastases. The safety profile was favorable, with a discontinuation rate of only 5%.II. Ivonescimab
Developer: Akeso / Summit Review Milestone: November 14, 2026In May 2024, Ivonescimab was first approved for marketing in China for the treatment of EGFR-TKI-resistant non-squamous non-small cell lung cancer (nsq-NSCLC). In April 2025, a second indication was approved for its use as a first-line treatment for PD-L1-positive NSCLC. To date, Ivonescimab has been administered to over 60,000 patients across dozens of clinical trials and real-world applications, fully validating its breakthrough clinical value and driving the iteration and advancement of cancer immunotherapy.The Biologics License Application (BLA) submitted to the FDA represents the first indication for which ivonescimab is seeking marketing approval overseas. This progress is not only a significant milestone in the global market expansion of ivonescimab but also marks the acceleration of China’s independently innovated bispecific antibody new drugs onto the international stage.This BLA is based on the overall data from HARMONi, the first global multicenter Phase III clinical study of ivonescimab. In EGFR-TKI–resistant non-squamous NSCLC, the HARMONi study demonstrated clear superiority over other FDA-approved therapies in both key endpoints: progression-free survival (PFS) and overall survival (OS). Compared with chemotherapy alone, ivonescimab plus chemotherapy yielded a PFS hazard ratio (HR) of 0.52, representing a 48% reduction in the risk of disease progression or death; the OS HR was 0.79 (0.80 in China), showing a clear benefit trend. These results are consistent with those of the HARMONi-A study in China, confirming the consistency of ivonescimab’s efficacy across regions.Ivonescimab is a next-generation cornerstone immuno-oncology drug, a global first-in-class innovation from Akeso Biopharma. Owing to its breakthrough clinical value, ivonescimab was featured in the “Spotlight On: The drugs that will shape 2026” list published by the international industry media outlet FirstWord Pharma. It was hailed as one of the 20 benchmark drugs poised to define the trajectory of the global pharmaceutical industry in 2026 and beyond, and to transform the paradigm of disease treatment. Notably, it is the only drug on this list independently developed by a Chinese innovative pharmaceutical company.III. Centanafadine
Developer: Otsuka Pharmaceutical Review Milestone: July 24, 2026Centanafadine is a once-daily, extended-release capsule and a potential first-in-class norepinephrine-dopamine-serotonin reuptake inhibitor (NDSRI) intended for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children, adolescents, and adults. If approved, Centanafadine would become the first FDA-approved NDSRI and the first novel-mechanism, non-stimulant therapy for ADHD in over two decades.The submission of this NDA is primarily supported by data from four pivotal Phase III clinical trials, which evaluated efficacy and safety in different patient populations: one trial in children (NCT05428033), one in adolescents (NCT05257265), and two in adults (NCT03605680, NCT03605836). Clinical studies demonstrated that centanafadine significantly reduces the core symptoms of ADHD in children, adolescents, and adults. Compared with placebo, centanafadine achieved statistically significant and clinically meaningful improvements in ADHD symptoms. Furthermore, the drug exhibited a favorable safety and tolerability profile across all studies, with a low risk of abuse. The most common adverse events in children and adolescents included decreased appetite, nausea, rash, fatigue, abdominal pain, and somnolence, whereas the most common adverse events in adults were decreased appetite and headache.IV. Povetacicept
Developer: Vertex / Zai Lab Review Milestone: November 30, 2026Povetacicept is a dual inhibitor of BAFF and APRIL. These two cytokines promote B-cell activation, differentiation, and/or survival. By inhibiting the capacity of BAFF and APRIL to drive the pathogenesis of various autoimmune diseases, povetacicept enables effective regulation of the antibody production process and is intended for the treatment of immunoglobulin A nephropathy (IgAN).The interim analysis at Week 36 of the Phase III RAINIER study demonstrated a 52.0% reduction from baseline in the urine protein-to-creatinine ratio (UPCR) in the treatment group, representing a 49.8% greater reduction compared with placebo (P<0.0001); hematuria resolution was achieved in 85.1% of patients (versus 23.4% in the placebo group). The safety profile was favorable, with no drug-related serious adverse events reported. If approved, patients could self-administer subcutaneous injections (<0.5 mL) at home every four weeks. This agent would become the first commercialized therapy in Vertex’s nephrology pipeline.Summary and Outlook
In the second half of 2026, the global innovative drug sector will witness several key regulatory review milestones. From GSK’s multi-billion-dollar bet on next-generation targeted therapies for lung cancer, to the FDA marketing application for ivonescimab, a domestically developed bispecific antibody from China; from centanafadine, the first non-stimulant with a novel mechanism of action for ADHD in over two decades, to povetacicept, which demonstrates clear efficacy advantages in IgA nephropathy—these drugs not only represent breakthroughs in their respective therapeutic areas but also reflect several important trends in current global new drug development.First, technological pathways continue to diversify. Multiple technical routes, including small-molecule targeted therapies and bispecific antibodies, are advancing in parallel, each making progress in deepening indications and optimizing safety profiles. Second, the global influence of Chinese innovative pharmaceutical companies is steadily rising. As the only Chinese-originated drug selected for prestigious international industry rankings, Ivonescimab’s FDA review process holds landmark significance. Third, unmet clinical needs remain the core driver of innovation. Whether in covering resistance mutations, treating brain metastases, developing non-stimulant medications for ADHD, or managing immune-mediated kidney diseases, the value of new drugs is ultimately reflected in tangible improvements in patient prognosis.It is worth emphasizing that drug review outcomes are subject to uncertainty, including the possibility that the FDA may require additional data, pricing strategies may affect accessibility, and long-term safety and resistance issues still require real-world validation.Overall, the review window in the second half of 2026 will serve as a critical value-validation milestone for the global pharmaceutical industry. The final outcomes for the aforementioned drugs will not only shape the competitive landscape among the relevant companies but also provide a reference for the development and regulatory pathways of subsequent similar products.- Lin JJ, et al. ALKOVE-1 trial results of Neladalkib in ALK+ NSCLC. ASCO Annual Meeting. 2026.
- Summit Therapeutics. Summit Therapeutics Announces U.S. FDA Acceptance of Biologics License Application (BLA) Seeking Approval for Ivonescimab in Combination with Chemotherapy. January 29, 2026.
- Otsuka Pharmaceutical. Otsuka Announces FDA Acceptance and Priority Review of New Drug Application for Centanafadine for the Treatment of ADHD. January 27, 2026.
- Vertex Pharmaceuticals. FDA Accepts Vertex's BLA for Povetacicept in IgA Nephropathy; PDUFA Set for November. May 31, 2026.
- Zhong, et al. Ivonescimab mechanism of action. iScience. 2025.
- First Word Pharma. Spotlight On: The drugs that will shape 2026.
- Drilon A, et al. ARROS-1 trial results of Zidesamtinib in ROS1+ NSCLC. IASLC World Conference on Lung Cancer. 2025.
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