On June 22, 2026 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, reported that as informed by the National Medical Products Administration ("NMPA"), the New Drug Application ("NDA") of satricabtagene autoleucel ("satri-cel"), the proprietary autologous humanized Claudin18.2 CAR T-cell therapy product, was approved for the treatment of patients with Claudin18.2-positive, HER2-negative advanced gastric/ gastroesophageal junction adenocarcinoma (G/GEJA) who have failed at least two prior lines of therapy. Satri-cel is the world’s first approved CAR T-cell therapy product for the treatment of solid tumors.

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Gastric cancer is one of the malignancies with the highest disease burden worldwide, ranking fifth in both incidence and mortality globally, with approximately 970,000 new cases and 660,000 deaths annually[1]. More than 70% of new and fatal cases occur in Asia[2], and Chinese patients account for approximately 47% of the global gastric cancer burden[3]. According to statistics from the National Cancer Center of China, there were approximately 360,000 new cases and 260,000 deaths from gastric cancer in China in 2022, ranking fifth in cancer incidence and third in cancer-related mortality[4]. Despite continuous advances in surgical techniques and comprehensive treatment modalities, gastric cancer is insidious in onset. In China, the proportion of early-stage gastric cancer diagnosis remains below 20%, and the 5-year survival rate for advanced gastric cancer is only about 10%[5]. Gastric cancer is characterized by high incidence, low early diagnosis rate, high heterogeneity, and high mortality. Conventional chemotherapy drugs have reached a plateau, targeted therapy options are limited, and the proportion and magnitude of benefit from immunotherapy still urgently need to be improved. Therefore, patients with unresectable or metastatic gastric cancer still face substantial unmet medical needs, and there is an urgent demand to drive the discovery and exploration of more precision therapies and novel anti-tumor agents.

Claudin18.2 is a highly selective marker protein. Its expression in normal healthy tissues is very limited, occurring only in differentiated gastric mucosal epithelial cells, whereas it is highly expressed in gastric cancer and other malignant tumors. Satri-cel is an autologous CAR-T cell product targeting Claudin18.2. It is genetically modified to express a CAR construct consisting of a humanized Claudin18.2-specific single-chain monoclonal antibody fragment (hu8E5-2I), a CD8α hinge region, a CD28 transmembrane region, a CD28 intracellular signaling domain (CD28 ICD), and a CD3ζ intracellular signaling region. To our knowledge, we were the first in the world to successfully identify, validate, and report the solid tumor-associated antigen Claudin18.2 as a valid target for CAR T-cell therapy. To further address the challenges of the tumor microenvironment in treating solid tumors, the company independently developed an innovative, patent-protected preconditioning regimen which is to be administered prior to infusion of satri-cel. This regimen features the addition of low-dose nab-paclitaxel to the conventional lymphodepletion regimen comprising cyclophosphamide and fludarabine to enhance the infiltration and anti-tumor efficacy of CAR T cells. The Company has implemented global patent layout around satri-cel, covering the target, indications, dosage, and preconditioning regimens, among others.

The clinical efficacy of satri-cel has received authoritative recognition from top international medical journals. The results of its confirmatory randomized controlled study have been published in The Lancet [6]. Clinical data show that among patients with advanced, heavily pretreated G/GEJ cancer who have extremely limited treatment options and a very poor prognosis, satri-cel demonstrated significant efficacy benefit and a good safety profile compared to existing treatments, bringing a new treatment option to patients with advanced gastric cancer. This major breakthrough not only establishes a new standard for CAR-T therapy in solid tumors but also lays a solid scientific foundation for advancing to earlier lines of therapy, exploring combination treatment regimens, and expanding applications to other Claudin18.2-positive solid tumors such as pancreatic cancer and biliary tract cancer.

Professor Lin Shen’s team at Peking University Cancer Hospital led the clinical studies of satri-cel. Professor Shen commented, "For patients with advanced G/GEJA who have failed multiple lines of prior therapy, previous treatment options were extremely limited and the prognosis was very poor. The approval of satri-cel provides us with a novel and effective therapeutic weapon. This product has brought clinically meaningful and significant benefits to such patients, with remarkable efficacy that is difficult to achieve with existing treatment modalities. More importantly, as a CAR-T product, satri-cel offers patients the opportunity to break free from the constraints of frequent hospital visits for treatment, achieving a leap from ‘prolonging survival’ to ‘improving quality of life.’ As the world’s first successfully marketed CAR-T therapy for solid tumors, satri-cel not only fills the gap in later-line treatment for advanced gastric cancer but also ushers in a new era of cellular therapy for solid tumors. This breakthrough lays a critical foundation for advancing frontline therapy and combination treatment strategies, and is expected to reshape the treatment landscape of gastric cancer and even gastrointestinal tumors. We believe that with the promotion of clinical application, this innovative therapy will illuminate new hope for life for the vast number of gastric cancer patients."

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen, stated, "The approval and launch of satri-cel is an important milestone event marking the advancement of CAR-T cell therapy from hematologic malignancies to solid tumors. This would not have been possible without the trust and support of the patients and their families who participated in the clinical trials, the investigator teams, partners, regulatory agencies, and relevant departments. We will go all out to advance the clinical application and market access of satri-cel, ensuring that this innovative therapy benefits Chinese patients widely and in a timely manner. At the same time, we will strive to expand this product to more countries and regions to meet greater medical needs. In addition, we are also exploring first-line sequential therapy and postoperative adjuvant therapy for advanced gastric cancer, with the aim of helping more patients achieve deeper therapeutic benefits and even the possibility of cure."

About Satri-cel

Satri-cel is an autologous CAR T-cell therapy product against the protein Claudin18.2 that is the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors. It was approved by the NMPA in June, 2026 for the treatment of Claudin18.2-positive, HER2-negative advanced gastric/ gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy, making it the world’s first approved CAR T-cell therapy product for solid tumors.

The Company is actively expanding satri-cel application in early-line treatment and perioperative treatment of cancer, including an ongoing Phase I clinical trial for pancreatic cancer adjuvant therapy in China (NCT05911217), an IIT for consolidation treatment following adjuvant therapy in patients with resected G/GEJA (NCT06857786) and an IIT for sequential therapy following first-line treatment for G/GEJA (NCT07179484).

(Press release, Carsgen Therapeutics, JUN 22, 2026, View Source [SID1234668872])

On June 22, 2026 Laboratoires Pierre Fabre reported that the European Commission (EC) has approved BRAFTOVI (encorafenib) in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC). The approval is based on the results from the Phase 3 BREAKWATER trial, which assessed the efficacy and safety of BRAFTOVI in combination with cetuximab and mFOLFOX6 in patients with previously untreated BRAFV600E-mutant mCRC, compared with oxaliplatin-based chemotherapy, with or without bevacizumab.

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Eric Ducournau, Chief Executive Officer, Laboratoires Pierre Fabre said: "We are extremely pleased to be able to expand the availability of encorafenib in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with BRAFV600E-mutant mCRC. Today’s EC decision for this regimen marks the approval of the only targeted therapy in the EU for this patient population in the first-line setting and an important milestone in that it helps to address a significant unmet need for patients and clinicians, for whom treatment options have been limited."

In the Phase 3 BREAKWATER trial, the regimen of BRAFTOVI in combination with cetuximab and mFOLFOX6 showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with oxaliplatin-based chemotherapy with or without bevacizumab (median PFS 12.8 vs. 7.1 months; hazard ratio [HR] 0.53; 95% confidence interval [CI], 0.41 to 0.68; P<0.001), and demonstrated a statistically significant improvement in the dual primary endpoint of ORR in the primary analysis set (60.9% vs. 40.0%; odds ratio 2.44; 95% CI: 1.40–4.25; P<0.001). A confirmed ORR was observed in 65.7% of patients (95% CI, 59.4 to 71.4) compared to 37.4% (95% CI, 31.6 to 43.7) in the oxaliplatin-based chemotherapy with or without bevacizumab group in the overall population.

(Press release, Pierre Fabre, JUN 22, 2026, View Source [SID1234668871])

On June 22, 2026 SystImmune Inc. (SystImmune), a clinical-stage biotechnology company, reported that its parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), has received regulatory approval from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for iza-bren (BL-B01D1) for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed following prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy. This approval marks the first regulatory approval for iza-bren and represents a significant milestone in the development of SystImmune’s proprietary bispecific antibody-drug conjugate platform.

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The approval is based on results from the pivotal Phase III BL-B01D1-303 study (NCT06118333). In this study, Iza-bren demonstrated a BICR-assessed confirmed ORR of 54.6% vs. 27.0% for chemotherapy (Odds Ratio 3.3; 95% confidence interval 1.9-5.8; p<0.0001). Median duration of response (DoR) was 8.5 months for iza-bren versus 4.8 months for physician’s choice of chemotherapy (Hazard ratio 0.43; 95% CI 0.22 to 0.83). Furthermore, median progression-free survival (PFS) was 8.38 months for iza-bren compared to 4.34 months for chemotherapy (hazard ratio of 0.44; 95% confidence interval 0.32-0.62). At the time of this analysis, the overall survival (OS) data were immature.

"This approval represents a significant milestone for patients with recurrent or metastatic nasopharyngeal carcinoma and for the development of iza-bren," said Dr. Jonathan Cheng, Chief Medical Officer of SystImmune. "Patients who have progressed following platinum-based chemotherapy and immunotherapy face a poor prognosis with limited treatment options. The approval of iza-bren provides a new therapeutic option that has demonstrated clinically meaningful improvements in tumor response and progression-free survival compared to chemotherapy."

"Today marks a historic milestone for Biokin and SystImmune as we celebrate the first regulatory approval of iza-bren anywhere in the world," said Dr. Yi Zhu, Chairman and Chief Executive Officer of Biokin. "In fact, this is the first bispecific ADC approval of any kind globally. This approval validates our innovative EGFR×HER3 bispecific ADC design and the potential of our proprietary brengitecan-based ADC platform. Most importantly, it brings an important new treatment option to patients with recurrent or metastatic nasopharyngeal carcinoma who urgently need better therapies. We thank the patients, investigators, and healthcare professionals who made this achievement possible and look forward to advancing iza-bren for patients worldwide across multiple tumor types."

About BL-B01D1-303
BL-B01D1-303 is a phase III, randomized, open-label, multicenter study in China to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic nasopharyngeal carcinoma who have failed PD-1/PD-L1 monoclonal antibody and at least two lines chemotherapy (one line must contain platinum-based chemotherapy). For more detailed information, please visit clinical.trials.gov (NCT06118333).

About Nasopharyngeal Carcinoma (NPC)
Nasopharyngeal carcinoma (NPC) is a cancer that arises from the nasopharynx, the upper part of the throat located behind the nose. Although uncommon globally, NPC is endemic in southern China, Southeast Asia, and certain regions of North Africa. Epstein-Barr virus (EBV) infection is strongly associated with the development of NPC. Patients with recurrent or metastatic disease who have progressed after standard therapies continue to face poor outcomes, with 5-year overall survival rate generally less than 10%, representing a significant unmet medical need.

About iza-bren
SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3, which are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic novel Topo1i payload is released causing cytotoxic stress that leads to cancer cell death.

(Press release, SystImmune, JUN 22, 2026, View Source [SID1234668869])

On June 22, 2026 Boehringer Ingelheim reported it is advancing biomarker-informed approaches and extending precision care across multiple cancers and stages of disease, reinforcing its ambition to bring unprecedented impact and improve long-term outcomes where unmet need remains high. The company has initiated two Phase III clinical trials within the DAREON program: DAREON-Lung-1 in small cell lung cancer (SCLC) and DAREON-NEC-1 in extrapulmonary neuroendocrine carcinoma (epNEC). In parallel, the Phase III Beamion LUNG-3 trial has been initiated in HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC).

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"People living with aggressive cancers often face a shortage of treatment choices," said Lykke Hinsch Gylvin, MD, Chief Medical Officer, Boehringer Ingelheim. "With the launch of these trials, we are advancing our precision oncology ambitions to move targeted therapies into earlier treatment lines and bring biomarker-informed science into late-stage development. By focusing on the biology of each tumor, we aim to give patients facing cancer more precise treatment options with the goal of improving outcomes where the need is greatest."

Biomarker-informed approaches: DLL3
The two DAREON Phase III trials mark a pivotal step for obrixtamig, Boehringer’s investigational DLL3/CD3 T-cell engager, and for the company’s broader biomarker strategy in aggressive neuroendocrine carcinomas (NECs) such as SCLC and epNEC. People with SCLC, the most aggressive type of lung cancer, often face short-lived therapeutic benefit and poor survival with existing approaches.5,7 EpNEC is a historically under-researched cancer for which survival outcomes have not improved in decades. For those living with these cancers, treatment options are limited and significant unmet needs persist.1,8

Delta-like canonical Notch ligand 3 is expressed on tumor cells in SCLC and epNEC while largely absent from non-cancerous cells. This makes it a potential predictive biomarker that could help to redefine treatment strategies for these aggressive cancers.9,10 DAREON-Lung-1 and DAREON-NEC-1 are designed to test whether the addition of obrixtamig, a DLL3 targeted T-cell engager, can improve outcomes in biomarker-informed patient populations versus the current standard of care.1,2 Together, the studies aim to position obrixtamig as part of a broader shift toward more personalized and potentially more transformative treatment approaches in these aggressive NECs.

Precision oncology in earlier stages: HER2
In addition, the company is investigating zongertinib in earlier stages of disease with the initiation of Beamion LUNG-3. This global, randomized Phase III trial will study the efficacy and safety of zongertinib as adjuvant monotherapy compared with physician’s choice standard of care in patients with stage II-IIIB HER2 (ERBB2)-mutant NSCLC who have undergone complete surgical resection and have received either neoadjuvant or adjuvant therapy.3 The study is designed to evaluate whether zongertinib can improve disease-free survival compared to standard of care following surgery, addressing the significant risk of recurrence after curative-intent treatment.11 Beamion LUNG-3 reflects the company’s focus on advancing targeted therapies earlier in the treatment pathway, where effective targeted adjuvant treatment options are not available.12 This trial extends the investigation of zongertinib to early stage disease.3

Expanding the oncology portfolio
Boehringer Ingelheim continues to expand its portfolio of precision oncology approaches that combine targeted therapies for biomarker-defined populations with innovative strategies to both activate and direct the immune system. This includes next-generation immunotherapies such as T-cell engagers, alongside complementary modalities that aim to enhance anti-tumor responses and address tumor-intrinsic drivers of disease. By integrating these approaches, the company aims to expand treatment options for people facing cancers with high unmet medical need.

About obrixtamig
Obrixtamig is an investigational novel Immunoglobin G (IgG)-like bispecific T-cell engager designed to bind concomitantly to DLL3 on tumor cells and CD3 on T-cells, potentially resulting in destruction of tumor cells by the body’s own immune system. Obrixtamig is being evaluated in multiple, ongoing clinical trials, including a Phase I trial in combination with atezolizumab and chemotherapy in extensive-stage small-cell lung cancer (ES-SCLC) patients (DAREON-8), a Phase Ib study to investigate obrixtamig in combination with the current SoC (carboplatin + etoposide) as 1L treatment for patients with DLL3-positive NEC, including epNEC (DAREON-7), and a Phase II trial in patients with relapsed/refractory DLL3-high extrapulmonary neuroendocrine carcinomas (epNEC) (DAREON-5).12,13,14 The Phase III clinical development program includes DAREON-LUNG-1, which evaluates obrixtamig in combination with atezolizumab plus chemotherapy vs. atezolizumab plus chemotherapy for first-line use in patients with ES-SCLC.1 In addition, DAREON-NEC-1 is evaluating obrixtamig in combination with current SoC (carboplatin and etoposide) vs. SoC alone as first-line therapy in patients with DLL3-positive unresectable locally advanced or metastatic epNEC.2

In order to tackle hard-to-treat cancers, Boehringer is drawing on innovation enabled through collaboration. The company is developing obrixtamig through a long-term partnership with Oxford BioTherapeutics (OBT), using OBT’s OGAP platform to identify novel target opportunities for new immunotherapies harnessing its investigational T-cell engager, investigational cancer vaccine and exploratory oncolytic virus platforms.

About zongertinib
Zongertinib is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby minimizing associated toxicities.16,17 Zongertinib is approved in the U.S., China, Hong Kong and Japan as the first once-daily orally administered targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer. Zongertinib is not approved in other markets.

The treatment is being evaluated in ongoing trials across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating zongertinib as a first-line treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations (NCT06151574).18 Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).

(Press release, Boehringer Ingelheim, JUN 22, 2026, View Source [SID1234668862])

On June 22, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported results from the final analysis of the dual primary endpoint of overall survival (OS) in the subset of patients without active liver metastases (non-liver metastases, NLM) in the phase 3 STELLAR-303 pivotal trial evaluating zanzalintinib in combination with atezolizumab (Tecentriq) versus regorafenib in previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer (mCRC). The results showed a non-statistically significant trend in OS favoring the combination in the NLM subpopulation (stratified hazard ratio: 0.83; 95% confidence interval: 0.66–1.05; P=0.1185), with median OS values of 15.9 months with zanzalintinib in combination with atezolizumab, and 12.7 months with regorafenib.

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The safety profile of zanzalintinib in combination with atezolizumab in the NLM subgroup was consistent with that previously reported in the intention-to-treat (ITT) population, and no new safety signals were identified.

Exelixis previously announced that STELLAR-303 met its other dual primary endpoint, demonstrating a statistically significant improvement in OS in the ITT population, which included all randomized patients regardless of the presence of active liver metastases. Detailed results demonstrating the statistically significant improvement in OS in the ITT population were presented at the 2025 European Society for Medical Oncology Congress and published in The Lancet.

In February 2026, Exelixis announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application (NDA) for zanzalintinib, in combination with atezolizumab, for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The FDA assigned a Prescription Drug User Fee Act target action date of December 3, 2026.

Detailed findings from the NLM subgroup analysis will be submitted for presentation at an upcoming medical conference.

About STELLAR-303
STELLAR-303 (NCT05425940) is a global, multicenter, randomized, phase 3, open-label study that randomized patients 1:1 to either zanzalintinib in combination with atezolizumab (n=451) or regorafenib (n=450). The study includes patients with previously treated non-MSI-high mCRC. The dual primary endpoints of the study are OS in the ITT population and in the NLM subgroup of patients. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Secondary endpoints include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. More information about the trial is available at ClinicalTrials.gov.

About Zanzalintinib
Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes, including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. The zanzalintinib development program includes a series of ongoing and planned pivotal trials to explore its therapeutic potential in CRC, clear cell and non-clear cell renal cell carcinoma, and neuroendocrine tumors, as well as earlier-stage trials in meningioma, lung cancer and castration-resistant prostate cancer.

Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials.

About CRC
CRC is the third most common cancer and a leading cause of cancer-related deaths in the U.S.1 Approximately 159,000 new cases will be diagnosed in the U.S. in 2026, with around 55,000 expected deaths from the disease.1 CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.2 Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is around just 15%.1,2 The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.

(Press release, Exelixis, JUN 22, 2026, View Source [SID1234668861])