Abbisko Therapeutics and AstraZeneca Enter a Strategic Collaboration to Conduct the Clinical Trial of Lumipodlin (ABSK043), a First-in-Class Oral PD-L1 Inhibitor, in Combination with TAGRISSO® for NSCLC

Rhea-AI Summary

Abbisko Therapeutics and AstraZeneca (NYSE:AZN) entered a strategic collaboration to develop an IO-TKI combination for EGFR-mutated, PD-L1 positive NSCLC. A multicenter, open-label Phase I/II trial will test Abbisko’s oral PD-L1 inhibitor lumipodlin (ABSK043) with AstraZeneca’s TAGRISSO (osimertinib). The investigational new drug application for this combination was cleared by China’s NMPA on May 20, 2026, and Abbisko will lead the Phase II study, with both companies sharing trial responsibilities.

Positive

• Strategic collaboration between Abbisko and AstraZeneca on NSCLC combination therapy
• NMPA cleared IND for lumipodlin plus TAGRISSO on May 20, 2026
• Multicenter, open-label Phase I/II trial in EGFR-mutated, PD-L1 positive NSCLC
• Targets a defined group with long-standing unmet medical need
• Abbisko to lead Phase II study, sharing trial responsibilities with AstraZeneca

Negative

• Combination remains in early Phase I/II, with safety and efficacy unproven

Market reaction after NSCLC clinical trial partnership: AZN +6.14% in the Jul 2 session

+6.14%

57 alerts

+6.14% Session close to close

$304.63B Market Cap

0.6x Rel. Volume

In the Jul 2 session, AZN gained 6.14%, reflecting a notable positive market reaction. Our momentum scanner triggered 57 alerts that day, indicating high trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved +6.1% in the session following this news. A strong upside move following this NSCLC ...

Analysis

The stock moved +6.1% in the session following this news. A strong upside move following this NSCLC trial collaboration would fit AstraZeneca’s recent pattern where oncology partnerships and approvals have attracted constructive interest, though net insider selling and low short positioning may temper the durability of any sharp advance.

Key Figures

IND clearance date: May 20, 2026

1 metrics

IND clearance date May 20, 2026 NMPA clearance of IND for lumipodlin plus TAGRISSO NSCLC study

Historical Context

5 past events · Latest: Jun 29 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 29	Oncology drug approval	Positive	+1.4%	EU approval of Enhertu as first tumor-agnostic HER2-directed ADC.
Jun 26	Oncology CHMP opinion	Positive	+1.5%	Positive CHMP opinion for Datroway in first-line TNBC monotherapy.
Jun 24	Cancer care partnership	Positive	+1.1%	Five-year multimillion-dollar YMCA partnership for cancer education and support.
Jun 12	US drug approval	Positive	-0.8%	US FDA approval of TRUQAP combo for PTEN-deficient prostate cancer.
Jun 02	Clinical data update	Negative	-1.3%	ODAC vote against camizestrant benefit‑risk in first-line HR+ breast cancer.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent oncology approvals and partnerships have generally produced modestly positive share reactions, with one prior case of a positive prostate cancer approval coinciding with a softer price move.

Key Terms

nmpa, pd-l1, egfr-tki, nsclc, +1 more

5 terms

nmpa regulatory

"was cleared by the National Medical Products Administration (NMPA)."

China’s National Medical Products Administration is the government agency that reviews and approves medicines, medical devices and cosmetics, and enforces safety and quality rules. Think of it as a gatekeeper or traffic controller: its approvals and inspections determine whether a product can be sold, how quickly it reaches patients, and what safety or labeling rules apply—factors that directly affect a healthcare company’s sales, costs and regulatory risk for investors.

pd-l1 medical

"oral small-molecule PD-L1 inhibitor, lumipodlin (ABSK043), in combination"

PD-L1 is a protein found on the surface of some cells that acts like a stop sign for the immune system, telling certain immune cells to back off. It matters to investors because many cancer drugs and diagnostic tests target or measure PD-L1 to unlock immune responses or predict which patients will benefit, affecting clinical success, regulatory approval, and potential sales in the oncology market.

egfr-tki medical

"AstraZeneca's third-generation EGFR-TKI, TAGRISSO"

EGFR-TKI are targeted cancer drugs that block a specific protein on tumor cells called the epidermal growth factor receptor (EGFR), which many cancers use to grow and divide; by blocking that signal they can slow or shrink tumors in patients whose cancers depend on EGFR. Investors watch EGFR-TKI closely because trial results, regulatory approvals, pricing and the emergence of drug resistance determine market size and revenue potential—like a specialized key that opens a valuable but sometimes fragile door to treatment demand.

nsclc medical

"for non-small cell lung cancer (NSCLC)."

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It develops in the lungs and can spread to other parts of the body, making it serious but often treatable if caught early. Understanding NSCLC helps people recognize the importance of lung health and early detection.

phase i/ii medical

"As a multicenter, open-label Phase I/II clinical study, the combination"

"Phase I/II" describes early stages of testing a new medicine or treatment, where researchers first evaluate its safety and then begin to see if it works. For investors, these phases are important because they indicate whether a product is progressing toward potential approval and commercialization, which can impact future value and success prospects. These stages help gauge how close a new treatment is to reaching the market.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

SHANGHAI, July 1, 2026 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter, HKEX code: 02256.HK) today announced that it has entered into a strategic collaboration agreement with AstraZeneca (LSE/STO/NYSE: AZN) to jointly advance the clinical development of a novel IO-TKI combination therapy for non-small cell lung cancer (NSCLC). As a multicenter, open-label Phase I/II clinical study, the combination will evaluate the safety and efficacy of Abbisko's first-in-class oral small-molecule PD-L1 inhibitor, lumipodlin (ABSK043), in combination with AstraZeneca's third-generation EGFR-TKI, TAGRISSO^® (osimertinib), for the treatment of patients with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC. On May 20, 2026, the investigational new drug (IND) application for the combination study was cleared by the National Medical Products Administration (NMPA). This Phase II study will be led by Abbisko, and both Abbisko and AstraZeneca will share responsibilities for the clinical trial.

Lumipodlin is a potentially first-in-class oral small molecule PD-L1 inhibitor with unique properties beyond its route of administration. Currently, third-generation EGFR-TKIs represented by osimertinib have become the front-line standard of care for EGFR-mutated NSCLC. However, patients with EGFR-mutant and high PD-L1 expression derive less benefit from EGFR-TKIs than those with low or negative PD-L1 expression^[1],^[2]. There is a long-standing unmet medical need for patients with EGFR mutated, PD-L1 positive NSCLC.

References
[1]  Brown H, Vansteenkiste J, Nakagawa K, et al. Programmed cell death ligand 1 expression in untreated EGFR mutated advanced NSCLC and response to osimertinib versus comparator in FLAURA. J Thorac Oncol. 2020;15(1):138–143.

[2]  Niu J, Jing X, Xu Q, et al. Strong PD-L1 affect clinical outcomes in advanced NSCLC treated with third-generation EGFR-TKIs. Future Oncol. 2024;20(32):2481-2490.

About Lumipodlin (ABSK043)
Lumipodlin is a novel, orally bioavailable, highly selective small molecule PD-L1 inhibitor independently developed and wholly owned by Abbisko Therapeutics. Tumor cells can exploit immune checkpoints such as PD-1 and its ligand PD-L1 to evade immune detection and clearance, thereby suppressing or limiting T-cell responses. Lumipodlin selectively binds to the PD-L1 receptor and induces its internalization from the cell surface, effectively inhibiting the PD-1/PD-L1 interaction and alleviating PD-L1-mediated suppression of T-cell activation. In preclinical models, lumipodlin has demonstrated anti-tumor efficacy comparable to approved PD-L1 antibodies. While several PD-1/PD-L1 monoclonal antibodies have been approved worldwide, there are currently no approved orally bioavailable PD-1/PD-L1 small molecule drugs. Lumipodlin is currently being explored in an ongoing Phase I clinical trial for advanced solid tumors in Australia and China.

About Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in EGFRm NSCLC, including against central nervous system metastases. Tagrisso (40mg and 80mg QD oral tablets) has been used to treat more than one million patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.

About Abbisko Therapeutics
Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK), is an oncology-focused biopharmaceutical company based in Shanghai that is dedicated to the discovery and development of innovative medicines to treat unmet medical needs in China and globally. The Company was established by a group of seasoned drug hunters with rich research & development and managerial expertise from top multinational pharmaceutical companies. Since its founding, Abbisko Therapeutics has built an extensive pipeline of innovative programs focused on precision oncology and immuno-oncology.

Please visit www.abbisko.com for more information.

About AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca.

Disclaimer: The indication for the combination therapy referenced in this document has not been approved in China. AstraZeneca and Abbisko Therapeutics do not recommend the use of any unapproved medicines.

View original content to download multimedia:https://www.prnewswire.com/news-releases/abbisko-therapeutics-and-astrazeneca-enter-a-strategic-collaboration-to-conduct-the-clinical-trial-of-lumipodlin-absk043-a-first-in-class-oral-pd-l1-inhibitor-in-combination-with-tagrisso-for-nsclc-302816115.html

SOURCE Abbisko

FAQ

What did AstraZeneca (AZN) announce about its collaboration with Abbisko Therapeutics for NSCLC?

AstraZeneca and Abbisko announced a strategic collaboration to develop an IO-TKI combination therapy for EGFR-mutated, PD-L1 positive NSCLC. According to Abbisko, the partnership centers on lumipodlin (ABSK043) combined with AstraZeneca’s third-generation EGFR-TKI, TAGRISSO (osimertinib), in a Phase I/II clinical trial.

What is lumipodlin (ABSK043) in AstraZeneca’s NSCLC collaboration with Abbisko?

Lumipodlin (ABSK043) is described as a potentially first-in-class oral small-molecule PD-L1 inhibitor. According to Abbisko, it will be evaluated in combination with AstraZeneca’s TAGRISSO in a Phase I/II study for EGFR-mutated, PD-L1 positive locally advanced or metastatic non-small cell lung cancer.

What are the key details of the Phase I/II lumipodlin and TAGRISSO trial for AZN investors?

The study is a multicenter, open-label Phase I/II clinical trial in EGFR-mutated, PD-L1 positive locally advanced or metastatic NSCLC. According to Abbisko, the trial will assess safety and efficacy of lumipodlin plus TAGRISSO, with Abbisko leading Phase II and both companies sharing responsibilities.

When was the IND cleared for the lumipodlin and TAGRISSO NSCLC combination study?

The investigational new drug application for the lumipodlin and TAGRISSO combination was cleared on May 20, 2026. According to Abbisko, China’s National Medical Products Administration (NMPA) granted this clearance, enabling the planned Phase I/II multicenter, open-label clinical study in EGFR-mutated, PD-L1 positive NSCLC.

Which NSCLC patients will the AstraZeneca and Abbisko lumipodlin trial target?

The trial will target patients with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC. According to Abbisko, current third-generation EGFR-TKIs like TAGRISSO provide less benefit in this subgroup, indicating a long-standing unmet medical need for these patients in clinical practice.

How does TAGRISSO feature in AstraZeneca’s new NSCLC trial with Abbisko?

TAGRISSO (osimertinib), AstraZeneca’s third-generation EGFR-TKI, will be combined with lumipodlin in the new trial. According to Abbisko, TAGRISSO is already a front-line standard of care for EGFR-mutated NSCLC and will be evaluated in EGFR-mutated, PD-L1 positive patients within this Phase I/II study.