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Sandoz announces strategic collaboration with Henlius on up to 10 biosimilars, further expanding industry-leading pipeline

On August 17, 2026 Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, reported a major development, manufacturing and commercialisation collaboration agreement with Shanghai Henlius Biotech, Inc. (Henlius, HKEX:02696), marking another significant step to broaden patient access to high-quality biosimilar medicines worldwide.

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The agreement paves the way for the two companies to collaborate on up to 10 biosimilars, with an initial bundle of assets already agreed. Under its terms, Sandoz will have global commercialisation rights for agreed biosimilar assets outside China, while Henlius will be responsible for development and manufacturing. The collaboration agreement is milestones-based for a total consideration of up to USD 322 million, with near-term payments associated with the initial assets that could reach up to USD 100.5 million.

Richard Saynor, Chief Executive Officer, Sandoz, says: "Expanding access to life-enhancing medicines for patients around the world lies at the heart of everything we do. By strengthening our collaboration with Henlius through this strategic agreement, one of our largest ever in biosimilars, we are not only underlining our commitment to patients but also taking another step towards capturing a significant share of the unprecedented biosimilar market opportunity that lies ahead."

One of the initial assets under the agreement will be a proposed cetuximab biosimilar, which is in clinical development. The reference medicine, Erbitux* (cetuximab), is an epidermal growth factor receptor-targeted oncology therapy used to treat selected patients with metastatic colorectal cancer and squamous cell carcinoma of the head and neck2, 3. Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer death worldwide4. According to the latest estimates, close to one million new cases of head and neck cancer are reported annually5.

In addition, the collaboration also covers a proposed evolocumab biosimilar used in patients with hypercholesterolaemia and for reducing the risk of major cardiovascular events in adults at increased cardiovascular risk6, and a proposed belimumab biosimilar intended for the treatment of active systemic lupus erythematosus in adults and children and active lupus nephritis in eligible patients, in addition to standard therapy7.Finally, there is an option for a recombinant human hyaluronidase to be used in the development of a subcutaneously administered biosimilar, which increases the dispersion and absorption of other injected medicines. The proposed evolocumab biosimilar and recombinant human hyaluronidase are in technical development, while belimumab is in early development.

Overall, the collaboration expands the industry-leading Sandoz biosimilar pipeline to 39 assets1, with the potential to increase to up to 46, and represents another milestone in the Company’s strategy to capitalise on a significant share of the unprecedented global biosimilar loss-of-exclusivity market over the next decade. It also builds on the existing collaboration between the two companies, first established in April 2025 through a global collaboration agreement for oncology therapy ipilimumab.

Sandoz continues to expand its industry-leading pipeline of biosimilar medicines, building on its experience as the pioneer and global leader with a portfolio of 13 molecules available in nearly 100 countries.

*Erbitux is a registered trademark of ImClone LLC.

(Press release, Sandoz, AUG 17, 2026, View Source [SID1234670161])

AbelZeta Regains Global Rights of C-CAR039 (Prizlon-cel) and Receives FDA Clearance of IND Application in Large B-cell Lymphoma

On August 17, 2026 AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, reported that the Company received the U.S. Food and Drug Administration (FDA) clearance of IND application for C-CAR039, also known as Prizloncabtagene Autoleucel (Prizlon-cel), an anti-CD20/CD19 bispecific CAR-T, for the treatment of relapsed or refractory (r/r) Large B-cell Lymphoma (LBCL).

In July 2026, AbelZeta regained all development, regulatory, manufacturing, commercialization, out-licensing and other collaboration rights relating to C-CAR039. The Company is currently working with the FDA to finalize the protocols for clinical development in third- or later-line LBCL patients previously treated with CAR-T therapies and second-line LBCL patients that are CAR-T therapy treatment naïve.

The program is supported by encouraging long-term clinical data presented at European Society for Blood and Marrow Transplantation (EBMT) in March 2026. Results from 48 patients with r/r B-cell non-Hodgkin lymphoma (B-NHL) enrolled in the Company’s early clinical trials in China demonstrated a favorable safety profile and deep and durable responses, with an overall response rate (ORR) of 91.5% and complete response (CR) rate of 85.1%. Median PFS was 60.1 months at a median follow-up of 53.9 months.

"We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "Clinical trial results to date have demonstrated the favorable safety and encouraging efficacy of C-CAR039 in r/r LBCL patients. We believe that it has potential to help patients who have been treated and relapsed with commercially approved CAR-T therapies. This population has significant unmet medical needs and C-CAR039 represents a solution. We will also explore the potential of C-CAR039 in early lines of LBCL. We remain confident about the potential of C-CAR039 and are fully committed to accelerating the global development of C-CAR039, leveraging our extensive expertise in cell therapy."

The registrational Phase II clinical trial of C-CAR039 for r/r LBCL in CAR-T therapy naïve patients in China is still ongoing.

(Press release, AbelZeta, AUG 17, 2026, View Source [SID1234670158])

HUTCHMED Announces ORPATHYS® Plus TAGRISSO® Demonstrated Statistically Significant and Clinically Meaningful Improvements in Progression-Free and Overall Survival in MET-Driven EGFR-Mutated Lung Cancer After Progression on TAGRISSO®

On August 16, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported that positive high-level results from the SAFFRON Phase III trial showed ORPATHYS (savolitinib) plus TAGRISSO (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival ("PFS") and overall survival ("OS") versus doublet platinum-based chemotherapy in patients with epidermal growth factor receptor-mutated ("EGFRm") non-small cell lung cancer ("NSCLC"). Patients in the trial had tumors with high levels of MET overexpression or amplification and had progressed on prior treatment with TAGRISSO.

Third-generation EGFR-tyrosine kinase inhibitors ("TKIs") have significantly improved outcomes for patients with EGFRm NSCLC.1 However, one in three patients’ tumors will develop MET overexpression or amplification, one of the most common mechanisms of resistance on third-generation EGFR-TKIs.1,2 MET-driven resistance is associated with poor prognosis, and there is a significant unmet need for effective and well-tolerated treatment options in later-line settings.2

Professor Shun Lu, Director of Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiao Tong University, School of Medicine and principal investigator of the trial, said: "These exciting results from SAFFRON represent a critical advance for patients with EGFR-mutated non-small cell lung cancer experiencing MET-driven resistance after osimertinib, a population with poor outcomes and no biomarker-directed treatment options available that are oral and well-tolerated. MET is one of the most common drivers of progression on targeted therapy in this setting, and these data underscore the potential impact of this novel osimertinib plus savolitinib combination and the urgency of MET testing to inform treatment decisions."

Dr Weiguo Su, Chief Executive Officer* and Chief Scientific Officer of HUTCHMED, said: "Overcoming MET-driven resistance after EGFR TKI therapy has been a long-standing challenge in clinical practice. The SAFFRON global study further reinforces the robust efficacy previously demonstrated in the SACHI Phase III trial that supported approval in China, with the results providing clear evidence to support global registrations of the TAGRISSO and ORPATHYS combination. We are grateful to everyone who supported this trial. Together with AstraZeneca, we look forward to potentially bringing this landmark treatment to patients around the world."

Dr Susan Galbraith, Executive Vice President, Oncology Hematology R&D, AstraZeneca, said: "These data demonstrate the clear benefit of adding ORPATHYS to backbone therapy TAGRISSO to address MET overexpression or amplification while maintaining EGFR suppression. By combining ORPATHYS and TAGRISSO, with its established efficacy, safety profile and central nervous system protection, we aim to deliver the first biomarker-directed, all-oral option in this setting to patients across the globe. This further strengthens our leadership in EGFR-mutated lung cancer, reinforcing our strategy to improve patient outcomes across stages and through lines of therapy with novel combinations."

The safety profile for ORPATHYS plus TAGRISSO was consistent with the known profiles of each medicine, and there were no new safety findings. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.

ORPATHYS plus TAGRISSO is approved in China for patients with locally advanced or metastatic EGFRm NSCLC with MET amplification after disease progression on EGFR-TKI therapy based on the SACHI Phase III trial.

ORPATHYS is being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca.

About NSCLC and MET aberrations

Lung cancer is the leading cause of cancer death globally, accounting for almost one in four (23%) cancer deaths.3 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% of patients diagnosed with NSCLC.4 Approximately 75% of NSCLC patients are diagnosed with advanced disease.5 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFRm NSCLC.6,7,8

MET is a tyrosine kinase receptor that has an essential role in normal cell development.9 MET overexpression or amplification can lead to tumor growth and the metastatic progression of cancer cells.9,10 An estimated 34% of tumors will develop high levels of MET overexpression or amplification after progression on a third-generation EGFR TKI.1

About SAFFRON

SAFFRON is a randomized, open-label, multi-center, global Phase III trial studying the efficacy of ORPATHYS (300mg twice daily) added to TAGRISSO (80mg once daily) versus doublet platinum-based chemotherapy in 338 patients with EGFRm, locally advanced or metastatic NSCLC with MET overexpression or amplification whose disease progressed following first- or second-line treatment with TAGRISSO. The trial enrolled patients in 230 centers across 29 countries, including in North America, Europe, South America and Asia. The primary endpoint is PFS and key secondary endpoints include OS and objective response rate (ORR).

Patients were prospectively selected for SAFFRON using the high MET level cut-offs identified in the SAVANNAH Phase II trial. In SAVANNAH, MET overexpression or amplification levels were determined by two tests: immunohistochemistry (IHC), which detects if cancer cells have a particular protein or marker on their surface, and fluorescence in situ hybridization (FISH), which detects a specific DNA sequence from cancer cells.

About ORPATHYS

ORPATHYS (savolitinib) is an oral, potent and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

ORPATHYS is approved in China for the treatment of adult patients with locally advanced or metastatic NSCLC with MET exon 14 skipping alteration, representing the first selective MET inhibitor approved in China. ORPATHYS also received a conditional approval in China for the treatment of patients with locally advanced or metastatic gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma patients with MET amplification who have failed at least two prior systemic treatments. ORPATHYS in combination with TAGRISSO is approved in China for patients with locally advanced or metastatic EGFR mutation-positive non-squamous NSCLC with MET amplification after disease progression on EGFR TKI therapy based on the SACHI Phase III trial. The combination was also granted a temporary authorization in Switzerland for the treatment of patients with locally advanced or metastatic EGFRm NSCLC and high levels of MET overexpression or amplification who progressed on prior treatment with TAGRISSO. This was based on results from the global SAVANNAH Phase II trial.

About TAGRISSO

TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including the treatment of 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.

TAGRISSO is approved as monotherapy in more than 120 countries including the US, EU, China and Japan. Approved indications include for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, adjuvant treatment of early-stage EGFRm NSCLC and locally advanced, unresectable NSCLC following platinum-based chemoradiation therapy. TAGRISSO is also approved in combination with chemotherapy in more than 80 countries, including the US, EU, China and Japan, for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

There is an extensive body of evidence supporting the use of TAGRISSO in EGFRm NSCLC, and it is the only targeted therapy shown to improve patient outcomes across all stages of the disease.

In late-stage disease, TAGRISSO demonstrated improved outcomes as monotherapy in the FLAURA Phase III trial and in combination with chemotherapy in the FLAURA2 Phase III trial. TAGRISSO is also being investigated in this setting in combination with DATROWAY (datopotamab deruxtecan or Dato-DXd) in the TROPION-Lung14 and TROPION-Lung15 Phase III trials.

TAGRISSO also showed improved outcomes in early-stage disease in the NeoADAURA and ADAURA Phase III trials and in locally advanced stages in the LAURA Phase III trial. As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, TAGRISSO is also being investigated in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

(Press release, Hutchison China MediTech, AUG 16, 2026, View Source [SID1234670162])

OSCOTEC Inc. Posts Operating Profit of 28.7 Billion Won in First Half, Returning to Profitability… Thanks to Technology Exports

On August 14, 2026 Oscotec reported the company returned to profitability in the first half of this year, driven by revenue from the technology export of "Sebidoplenib" and sales of "Lecraza," a treatment for non-small cell lung cancer.

OSCOTEC Inc.(039200)The company announced on the 14th that its consolidated revenue for the first half of this year reached 56.3 billion won, a 371.0% increase compared to the same period last year. Operating profit for the same period was 28.7 billion won, marking a turnaround from a 9.0 billion won loss in the same period last year. Net profit also reached 35.8 billion won, shifting from a 10.3 billion won loss in the first half of last year to a profit.

The improvement in performance was particularly concentrated in the second quarter of this year. OSCOTEC Inc.’s second-quarter revenue reached 52.6 billion won, a 425.6% increase compared to the same period last year. Operating profit stood at 38.7 billion won, and net profit at 40.8 billion won, both turning from a loss in the same period last year to a profit. Although the company posted an operating loss of approximately 10 billion won in the first quarter, it recorded a profit for the first half of the year as large-scale technology transfer revenue was reflected in the second quarter.

The improvement in performance was driven by revenue from new drug technology transfers. Revenue from technology transfers in the first half of the year totaled 49.8 billion won, accounting for 88.5% of total revenue. Royalty revenue amounted to 4.9 billion won, while revenue from the sale of goods was 1.5 billion won.

In particular, the technology transfer agreement for "Cevidoplenib," a candidate drug for autoimmune diseases jointly developed by OSCOTEC Inc. and its U.S. subsidiary Genosco, contributed significantly to the company’s performance.

In June, OSCOTEC Inc. signed an agreement with U.S.-based Agios Pharmaceuticals to transfer the global development and commercialization rights for Cevidoplenib. Consequently, 34 billion won was recognized as technology transfer revenue in the first half of the year in connection with the non-refundable upfront payment of $25 million (approximately 34 billion won) received under the agreement.

Revenue related to Lecraza also increased. Milestone and royalty revenue recognized in the first half of the year for Lecraza—a non-small cell lung cancer treatment that OSCOTEC Inc. licensed to Yuhan Corporation—totaled approximately 20 billion won, a 1.9-fold increase from the approximately 10.5 billion won recorded in the first half of last year.

Amid these substantial technology transfer revenues, research and development (R&D) investment expanded. OSCOTEC Inc.’s R&D expenses recognized in the first half totaled 15 billion won, a 20.6% increase from the 12.5 billion won recorded in the same period last year.

Financial capacity also grew. As of the end of the first half, OSCOTEC Inc.’s cash and cash equivalents stood at 32.4 billion won, and short-term financial assets at 178.3 billion won, bringing total liquid assets to 210.7 billion won. This represents nearly a twofold increase from the 108.1 billion won recorded at the end of last year.

OSCOTEC Inc. plans to utilize the secured funds to continue investing in its own R&D. The company intends to continue developing its follow-on pipeline, including the Phase 1 clinical trial for OCT-598 and OCT-648, while also expanding its research workforce.

An OSCOTEC Inc. official stated, "Based on the funds and liquidity secured through recent technology transfer and commercialization achievements, we plan to proceed with the R&D of our core follow-on pipeline without any delays," adding, "We currently have a structure in place that allows us to pursue our own R&D investments and scale expansion without the need for additional fundraising."

(Press release, Oscotec, AUG 14, 2026, View Source [SID1234670962])

CASI Pharmaceuticals Announces First Half 2026 Business and Financial Results

On August 14, 2026 CASI Pharmaceuticals, Inc. (OTCQB:CASIF), a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody, for patients with antibody-mediated rejection (AMR) in organ transplant and various autoimmune diseases, reported business and financial results for the first half year ended June 30, 2026.

"We remained focused on advancing the development of our lead program, CID-103," said Dr. Wei-Wu He, Executive Chairman and Principal Executive Officer of CASI. "We dosed the first patient in the Phase 1/2 trial evaluating the safety and tolerability of CID-103 in adult patients with active and chronic active renal allograft antibody-mediated rejection (AMR) in China. We also completed the enrollment of Part A (the dose-escalation part) of our ongoing Phase 1/2 study in immune thrombocytopenia (ITP), with the maximum tested dose of 1,200 mg."

Business Highlights

Program Updates and Upcoming Milestones

CID-103 for Antibody-Mediated Rejection (AMR) for Renal Allografts

Approval of clinical trial application by China NMPA for Phase 1/2 study

First patient dosed in Phase 1/2 study in China

CID-103 for Immune Thrombocytopenia (ITP)

Completed enrollment in Part A, the dose-escalation part, of the ongoing Phase 1/2 study, with the maximum tested dose of 1,200 mg

Corporate

Completed $15 million convertible note financing pursuant to certain convertible note purchase agreement with ETP Global III Fund LP, a partnership controlled by Dr. Wei-Wu He

Dr. Wei-Wu He, Ph.D., assumed the role of the Company’s principal executive officer while continuing to serve as Executive Chairman

Subsequent to quarter-end, received a favorable final award in the Juventas arbitration, pursuant to which the tribunal rejected all of Juventas’s allegations of breach, determined that Juventas had wrongfully terminated the relevant agreements, and awarded the Company amounts totaling well over RMB 100 million

Entered into a Settlement Agreement with Acrotech Biopharma Inc., pursuant to which the prior purported termination of the EVOMELA license and related agreements was rescinded and the agreements remain in full force and effect, subject to certain revisions

Ordinary shares began to be quoted for trading on the OTCQB market under the ticker CASIF

First Half 2026 Financial Highlights

Revenues for the first half of 2026 were $9.8 million, representing a 5.8% decrease compared to $10.4 million in the same period last year. The decline in revenue was primarily attributable to the product transition from EVOMELA to the locally manufactured MAFALAN, which remains in its market‑expansion phase.

Cost of revenue for the first half of 2026 was $2.2 million, representing a 53.2% decrease compared to $4.7 million in the same period last year. The decrease was mainly attributable to lower unit cost for MAFALAN than that of EVOMELA.

Research and development expenses for the first half of 2026 were $2.3 million, representing a 37.8% decrease compared to $3.7 million in the same period last year. The decrease was mainly attributable to decreased clinical studies costs for our pipeline products, as well as decreased labor cost.

General and administrative expenses for the first half of 2026 were $14.3 million, representing a 3.6% increase compared to $13.8 million in the same period last year. The increase was mainly attributable to increased legal fees, partially offset by decreased labor cost.

Selling and marketing expenses for the first half of 2026 were $7.5 million, representing an 18.5% decrease compared to $9.2 million in the same period last year. The decrease was mainly attributable to decreased labor cost and decreased travel and conference fees.

Net loss for the first half of 2026 was $20.0 million, compared to $24.1 million in the same period last year.

As of June 30, 2026, cash and cash equivalents of the Company was $3.8 million, compared to $5.6 million as of December 31, 2025.

As of June 30, 2026, total outstanding shares of the Company were 20,555,873.

Nasdaq Delisting and OTCQB Quotation

On February 23, 2026, the Company received a determination letter from the Hearings Panel of The Nasdaq Stock Market notifying the Company that the Panel had determined to delist the Company’s securities due to the Company’s failure to satisfy Nasdaq’s continued listing requirements. As a result, trading in the Company’s securities was suspended at the opening of business on February 26, 2026. On June 23, 2026, Nasdaq filed Form 25 in relation to such delisting decision.

On April 14, 2026, the Company’s ordinary shares began to be quoted for trading on the OTCQB market under the ticker CASIF.