On August 17, 2026 Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL) ("Zentalis" or the "Company"), a clinical oncology innovator advancing late-stage development of an investigational, potentially first-in-class WEE1 inhibitor, azenosertib, as a biomarker-driven treatment approach for ovarian cancer, reported that it has closed its previously announced underwritten public offering of 26,450,000 shares of its common stock, including 3,450,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares. The shares of common stock were sold to the public at a price of $3.50 per share. The total gross proceeds to the Company from the offering, before deducting underwriting discounts and commissions and offering expenses, were approximately $92.6 million. All of the shares of common stock sold in the public offering were sold by the Company.

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The Company intends to use the net proceeds from the offering, together with the Company’s existing cash, cash equivalents and marketable securities, to fund clinical trials, preclinical studies, regulatory filings, manufacturing and the Company’s companion diagnostic in support of its programs, as well as for pre-commercial activities, capital expenditures, working capital and other general corporate purposes.

TD Cowen, Guggenheim Securities and Oppenheimer & Co. acted as joint bookrunners for the offering. H.C. Wainwright & Co. acted as a passive bookrunner for the offering. Rodman & Renshaw LLC acted as a manager for the offering.

The securities described above were offered pursuant to an effective shelf registration statement that was filed with the U.S. Securities and Exchange Commission (SEC) on March 26, 2025, and became effective on April 4, 2025. This offering was made only by means of a prospectus supplement and the accompanying prospectus which forms a part of the effective shelf registration statement.

A final prospectus supplement related to the offering (including the accompanying prospectus) has been filed with the SEC and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement related to the offering and the accompanying prospectus may be obtained by visiting the SEC’s website or by contacting: TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities in this offering in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

(Press release, Zentalis Pharmaceuticals, AUG 17, 2026, View Source [SID1234670194])

On August 17, 2026 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the registrational Phase III study of the Company’s novel BCL2 inhibitor mesutoclax (ICP-248) in combination with azacitidine versus venetoclax with azacitidine in elderly or unfit patients with treatment naive (TN) acute myeloid leukemia (AML).

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The head-to-head randomized, open-label, multicenter registrational Phase III clinical trial is designed to demonstrate the superiority of mesutoclax in combination with azacitidine over venetoclax with azacitidine in elderly or unfit patients with treatment naive AML. The primary endpoint is overall survival (OS).

Mesutoclax is a novel, orally bioavailable BCL2 selective inhibitor. BCL2 is an important regulatory protein in the apoptosis pathway, and its abnormal expression is associated with the development of various hematologic malignancies. Mesutoclax exerts anti-tumor activity by selectively inhibiting BCL2 and restoring the normal apoptosis process in cancer cells. Mesutoclax has been granted two Breakthrough Therapy Designations (BTD) by the CDE.

Data presented at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrated that mesutoclax in combination with azacitidine in patients with AML achieved outstanding efficacy and safety. As of April 13, 2026, among the evaluable TN AML patients, 81.8% achieved composite CR (cCR, CR+CRi). Among patients who achieved overall response, 86.5% were MRD (Minimal Residual Disease) negative. Among cCR responders, 83% achieved cCR in the first treatment cycle, demonstrating that the mesutoclax regimen enables rapid and deep remission. In terms of safety, no dose-limiting toxicities (DLTs) were observed, and the maximum tolerated dose (MTD) was not reached. Notably, both 30-day mortality and 60-day mortality were 0% among TN AML patients. At the recommended dose, the 6-month overall survival (OS) rate was 90.5%.

Dr. Jasmine Cui, Co-founder, Chairwoman, and CEO of InnoCare, said, "The efficacy and safety mesutoclax has demonstrated to date give us the confidence to test it head-to-head against the global standard of care. Mesutoclax is one of our key global assets. We have been accelerating the global trial of mesutoclax in combination with azacitidine for AML, with patients enrolled in the U.S. and Australia. We will further advance its clinical development to bring this innovative therapy to more patients worldwide as early as possible."

AML is a malignant hematological disease originating from hematopoietic stem/progenitor cells. The risk of developing AML increases with age and is more common among older adults.

(Press release, InnoCare Pharma, AUG 17, 2026, View Source [SID1234670193])

On August 17, 2026 Astrazeneca reported that positive high-level results from the SAFFRON Phase III trial showed TAGRISSO (osimertinib) plus savolitinib 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.

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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 Jiaotong 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."

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: "These data demonstrate the clear benefit of adding savolitinib to backbone therapy TAGRISSO to address MET overexpression or amplification while maintaining EGFR suppression. By combining savolitinib 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."

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 savolitinib 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."

The safety profile for TAGRISSO plus savolitinib 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.

TAGRISSO plus savolitinib 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.

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

IMPORTANT SAFETY INFORMATION FOR TAGRISSO (osimertinib)

There are no contraindications for TAGRISSO
TAGRISSO can cause severe and fatal interstitial lung disease (ILD)/pneumonitis. ILD/pneumonitis occurred in 4% of the 1813 patients treated with TAGRISSO monotherapy who had not received recent definitive chemoradiation therapy; 0.4% of cases were fatal
ILD/Pneumonitis with TAGRISSO in combination with Pemetrexed and Platinum-based Chemotherapy:

In the FLAURA2 study, ILD/pneumonitis occurred in 3.3% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 0.4% of cases were fatal
ILD/Pneumonitis Following Definitive Platinum-based Chemoradiation Therapy (CRT):

In the LAURA study, following definitive platinum-based CRT, ILD/pneumonitis including radiation pneumonitis, occurred in 80 of the 143 patients (56%) who received TAGRISSO monotherapy and 28 of the 73 patients (38%) who received placebo. There was one fatal case (0.7%), 3.5% Grade 3, 34% Grade 2, and 18% Grade 1 adverse reactions of ILD/pneumonitis in TAGRISSO-treated patients. For TAGRISSO-treated patients, ILD/pneumonitis led to permanent discontinuation of TAGRISSO in 7% of patients and dosage interruptions of TAGRISSO in 35% of patients. Among the 46 patients who were rechallenged with TAGRISSO, 11% had recurrence of ILD/pneumonitis. In the 80 TAGRISSO-treated patients, ILD/pneumonitis resolved in 40%, resolved with sequelae in 1.3%, were resolving in 16%, did not resolve in 41%, and resulted in death in 1.3%
For patients receiving TAGRISSO who have not received recent definitive platinum-based CRT, withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (e.g., dyspnea, cough, and fever). Permanently discontinue TAGRISSO if ILD/pneumonitis is confirmed. For patients who have received recent definitive platinum- based CRT with Grade 1 ILD/pneumonitis, continue TAGRISSO or interrupt and restart, as appropriate. Permanently discontinue TAGRISSO in patients diagnosed with Grade ≥2 ILD/pneumonitis

TAGRISSO can cause heart rate-corrected QT (QTc) interval prolongation. Of the 1813 TAGRISSO monotherapy-treated patients in clinical trials, 1.1% were found to have a QTc >500 msec, and 4.3% of patients had an increase from baseline QTc >60 msec. Of the 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study, 1.8% were found to have a QTc >500 msec, and 10.5% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Clinical trials of TAGRISSO did not enroll patients with baseline QTc of >470 msec. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia
TAGRISSO can cause cardiomyopathy, including cardiac failure, chronic cardiac failure, congestive heart failure, pulmonary edema or decreased ejection fraction. Cardiomyopathy occurred in 3.8% of the 1813 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. In the FLAURA2 study, cardiomyopathy occurred in 9% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 1.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 4.2% of 1557 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. In the LAURA study, following platinum-based CRT, 3% (4/135) of TAGRISSO-treated patients and no placebo-treated patients experienced LVEF decreases ≥10% and a drop to <50%. In the FLAURA2 study, 8% (21/262) of patients treated with TAGRISSO in combination with pemetrexed and platinum- based chemotherapy, who had baseline and at least one follow-up LVEF assessment, experienced LVEF decreases ≥10% and a drop to <50%. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors, including assessment of LVEF at baseline and during treatment. For patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO
Keratitis was reported in 0.6% of 1813 patients treated with TAGRISSO monotherapy in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist
Postmarketing cases consistent with erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if EMM, SJS, or TEN is suspected and permanently discontinue if confirmed
Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity
Aplastic anemia has been reported in TAGRISSO-treated patients in clinical trials (0.06% of 1813) and postmarketing. Some cases had a fatal outcome. Inform patients of the signs and symptoms of aplastic anemia including but not limited to, new or persistent fevers, bruising, bleeding, and pallor. If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated
Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the last dose
Because of the potential for serious adverse reactions in breastfed infants from TAGRISSO, women should not breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose
Most common (≥20%) adverse reactions, including laboratory abnormalities, were:
TAGRISSO monotherapy: leukopenia, lymphopenia, thrombocytopenia, anemia, diarrhea, rash, musculoskeletal pain, neutropenia, nail toxicity, dry skin, stomatitis, and fatigue
TAGRISSO monotherapy following platinum-based chemoradiation therapy: lymphopenia, leukopenia, ILD/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough and COVID-19
TAGRISSO in combination with pemetrexed and platinum-based chemotherapy: leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine
INDICATIONS

TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy, for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the treatment of adult patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy
Please see complete Prescribing Information, including Patient Information for TAGRISSO.

Notes

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.​6-8

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 ​

SAFFRON
SAFFRON is a randomized, open-label, multi-center, global Phase III trial studying the efficacy of savolitinib (300 mg twice daily) added to TAGRISSO (80 mg 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 1st- or 2nd-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.

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.

Savolitinib
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.

Savolitinib 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. Savolitinib also received a conditional approval in China for the treatment of patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET amplification who have failed at least two prior systemic treatments.

Savolitinib in combination with TAGRISSO is approved in China for patients with locally advanced or metastatic EGFRm-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.

TAGRISSO (osimertinib)
TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including the treatment of central nervous system metastases. TAGRISSO (40 mg and 80 mg 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 1st-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 1st-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 datopotamab deruxtecan-dlnk 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, AstraZeneca, AUG 17, 2026, View Source [SID1234670192])

On August 17, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or the "Company", Stock Code: 6990.HK) reported its unaudited consolidated results for the period ended 30 June 2026 (the "Reporting Period").

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Key information is as follows:

Revenue amounted to approximately RMB 978 million, with sales of pharmaceutical products reaching RMB 657 million, up by 112% compared to the same period last year, driven by two factors: expert recognition of high quality clinical data and shift in treatment paradigms, and comprehensive enhancement of drug accessibility.
The Company has established a comprehensive operational system in China encompassing R&D, manufacturing, quality management, and commercialization, with integrated drug development capabilities. The Company is also pursuing global expansion through international collaborations, leveraging external partnerships to accumulate global clinical development and commercialization experience, while exploring diversified pathways to progressively achieve independent overseas market entry.
Focusing on ADC and novel DC, the Company not only has two ADC products that have been approved for marketing, but has also built a product pipeline that is differentiated and complimentary to approved ADCs in indications, efficacy performance and safety profile. Through the free combination of conjugation drug components, as well as the pairing with a diverse range of targeting conjugates including antibodies, small molecules, and peptides that leverage TAA/IO/ anti-angiogenetic-based mechanisms, the Company has proactively positioned innovative DC assets, including single-payload DCs such as radioisotope-based/ immuno-agonist-based/degrader-based, and dual-payload DCs such as cytotoxin + cytotoxin or immuno-agonist or degrader combinations, among others.
Doubling down on ADC + IO therapies, including the combination of ADCs with PD-(L)1 or PD-1/VEGF agents, as well as the development of drug candidates with synergetic MoAs within one ADC compound.
Beyond oncology, the Company has also expanded into important therapeutic areas such as autoimmune and metabolic diseases, and is currently conducting multiple clinical studies for asthma, chronic obstructive pulmonary disease (COPD), and atopic dermatitis.
Clinical development progresses efficiently, with a tiered expansion of the pipeline matrix

Focusing on high-incidence tumors such as lung cancer and breast cancer, the Company has built a well-layered clinical pipeline with significant synergistic potential, covering drug modalities including ADCs, immunotherapies, and small-molecule targeted therapies, while further expanding into major therapeutic areas such as autoimmune and metabolic diseases.

Approved ADC Products

Sac-TMT (TROP2 ADC, sacituzumab tirumotecan) (also known as SKB264/MK-2870) (佳泰莱)
The product has currently received marketing approval for four indications, namely 2L+ TNBC, 2L/3L EGFR-mutant NSCLC, and 2L+ HR+/HER2- BC. In addition, two new indication drug applications have been accepted for review, covering the combination with pembrolizumab for 1L PD-L1-positive NSCLC, and as a monotherapy for 1L TNBC.

Clinical progress in the reporting period:

Marketing approval for 2L+ HR+/HER2- BC
New indication drug applications accepted for 1L TNBC and 1L PD-L1-positive NSCLC
The OptiTROP-Lung06 registrational trial in China for 1L PD-L1-negative non-squamous NSCLC met primary endpoint
The global Phase 3 TroFuse-005 trial for 2L+ EC met primary endpoints
Two global Phase 3 trials for OC & UC initiated in H1 2026
Phase 2 study in combination with SKB118 for NSCLC initiated
Granted BTD for 1L PD-L1-positive NSCLC from NMPA
Drawing on all the aforementioned key advances, sac‑TMT has clearly embodied four core development strategies: advancing from monotherapy to combo-therapy, shifting from later-line to earlier-line treatment settings, expanding indications, and conducting clinical research from China to the global.

Trastuzumab botidotin (HER2 ADC, also known as A166) (舒泰莱)
One indication has received marketing approval for the treatment of 2L+ HER2+ BC. Its Phase 2 clinical study in HER2+ BC patients previously treated with topoisomerase inhibitor ADCs is ongoing.

Other ADC and novel DC assets

The Company has also built a pipeline of innovative assets that are differentiated from and complementary to approved ADCs in indications, efficacy and safety profile, including SKB315 (CLDN18.2 ADC), SKB410 (Nectin-4 ADC), SKB571 (novel bsADC), SKB107 (RDC), SKB103 (TAA-IO bsADC), and SKB565 (novel dual-payload ADC), among others.

Non-DC Assets

Clinical progress in the reporting period:
SKB118/CR-001 (PD-1/VEGF bsAb): The IND application for the treatment of solid tumors has been approved by the NMPA, and a Phase 1/2 clinical trial is ongoing.
SKB378/WIN378 (TSLP mAb): A Phase 1 clinical trial in healthy subjects has been completed in China, and its IND application for the treatment of COPD has also been approved by the NMPA.
SKB575 (TSLP/undisclosed target bsAb): Phase 1 clinical trials for atopic dermatitis and asthma are ongoing in China.

Major Key Research Findings Presented at International Academic Conferences & Journals

The Phase 3 trial evaluating sac-TMT plus pembrolizumab versus pembrolizumab monotherapy for first-line treatment of PD-L1-positive advanced NSCLC was delivered as an oral presentation at ASCO (Free ASCO Whitepaper) 2026 and concurrently published in The Lancet. Compared with single-agent immunotherapy, this combination regimen yielded a significant prolongation in PFS (HR = 0.35), with consistent PFS benefits observed across all predefined subgroups; an OS benefit trend was also observed (HR = 0.55).
The final OS analysis results from the pivotal study of sac-TMT for 3L EGFR-mutant NSCLC were selected as a LBA at ELCC 2026 and presented as a mini oral presentation.
Lunbotinib Fumarate Capsules (RET inhibitor, also known as A400/EP0031) (宁泰莱[1]): Key Phase 2 clinical results for advanced RET fusion-positive NSCLC were presented in an oral presentation at ASCO (Free ASCO Whitepaper) 2026.
Multiple products gain market traction, with robust commercial growth momentum

To date, the Company has received marketing authorization for sac-TMT (佳泰莱), tagitanlimab (科泰莱), Cetuximab N01 (达泰莱) and trastuzumab botidotin (舒泰莱), of which 3 products covering 5 indications have been included in the National Reimbursement Drug List (NRDL). The Company has also submitted an NDA for Lunbotinib Fumarate Capsules, and upon regulatory communication and marketing approval, commercialization is expected to commence in the first half of 2027. With this, the Company’s initial commercial product portfolio, comprising 5 products, has taken shape.

In the first half of 2026, the total revenue from sales of pharmaceutical products reaching RMB 657 million, up by 112% compared to the same period last year.

Major growth drivers:

Expert Recognition of High‑Quality Clinical Data and Shift in Treatment Paradigms:

Data from a number of high‑quality clinical studies of international caliber have continued to be released, thereby continuously reinforcing the evidence-based clinical foundation of our products.
Recognized through authoritative endorsement from clinical guideline experts, as reflected in guidelines (CSCO, etc.) and clinical expert consensus.
佳泰莱 is recognized as the "standard of care in 2L and the preferred regimen in 3L" in the LC, and is also the preferred brand among TROP2 ADC in TNBC.
Through ongoing medical education and academic exchange activities, clinicians have gained a deeper understanding of the products. Treatment paradigms have also evolved gradually.
Comprehensive Enhancement of Drug Accessibility

Effective translation of the benefits of NRDL inclusion: 3 indications of 佳泰莱 and 达泰莱 have been included in the 2025 NRDL, which officially took effect on January 1, 2026. This marks 佳泰莱 the only TROP2 ADC and the only domestic ADC in TNBC/NSCLC under the NRDL
Broader hospital access channels: Covers 30 provinces, over 300 prefectures and over 2,000 hospitals; Broaden reimbursement channels, including formal access, temporary procurement and dual-channel reimbursement;
Continuous expansion of the commercialization team: Established a team of 800+; nearly doubling YoY; Achieved extensive grassroots coverage of top-tier hospitals in high-potential districts
Sac-TMT (佳泰莱) achieved positive results in its first global Phase 3 trial, accelerating global collaboration progress

Collaboration with Merck Sharp & Dohme (hereinafter referred to as the "MSD") (默沙东): MSD has initiated 17 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or in combination with pembrolizumab or other agents for several types of cancer, with indications covering breast cancer (BC), lung cancer (LC), gynecologic cancers, gastrointestinal (GI) cancers, and genitourinary (GU) cancers.
In May 2026, MSD announced that the pivotal Phase 3 Trofuse-005 trial met its primary endpoints of OS and PFS in certain patients with advanced or recurrent EC. TroFuse-005 is the first global Phase 3 trial to demonstrate statistically significant improvement in both OS and PFS compared to chemotherapy for these patients, and sac-TMT is the first and only ADC to do so for patients with EC in this setting.
Beyond sac‑TMT, the Company has also entered into collaborations with MSD on certain ADC assets, continuously exploring the optimal ADC pipeline portfolio.
Collaboration with Ellipses Pharma: Lunbotinib Fumarate Capsules (A400/EP0031) have received FDA approval to proceed into Phase 2 clinical development. A total of 42 clinical trial sites has been established in the United States, UK, Europe, and the United Arab Emirates for Lunbotinib Fumarate Capsules.
Collaboration with Windward Bio: Windward Bio is evaluating SKB378/WIN378 in the POLARIS Phase 2/3 global trial in patients with asthma and has dosed the first patients in the SIRIUS Phase 2 global study in patients with COPD.
Collaboration with Crescent Biopharma: Entered into a licensing collaboration with Crescent Biopharma for SKB105/CR-003.
ESG capabilities continue to strengthen, delivering outstanding results in capital market performance.

In terms of ESG, in May 2026, the Company was included in the "China ESG Impact List" by Fortune and was awarded bronze medal for "Most Committed to ESG (China)" under "Asia’s Best Company" by FinanceAsia. In March 2026, the Company had received a rating of "AA" in the MSCI ESG Rating Assessment.

In terms of capital markets, the Company was approved by the Hong Kong Stock Exchange to officially remove the "B" marker from its stock code on April 14, 2026. In addition, the Company completed the placing of H Shares in July 2026, with net proceeds from the Placing amounting to approximately HK$2,723.4 million.

Prospect

Kelun-Biotech will continue to drive innovation and strengthen its operational capabilities, steadily advancing towards becoming a world-class biopharmaceutical company. Specifically, the Company will implement the following development strategies: advancing differentiated pipelines targeting indications with significant medical needs; optimizing payload-linker strategies and novel DC designs and structures, while expanding applications in non-oncology diseases; enhancing its end-to-end drug development and commercialization capabilities; expanding its global footprint through strategic partnerships and improve our capabilities for the development, registration and commercialization of our products in ex-China market; and optimizing its operational systems with the aim of becoming a leading global biopharmaceutical company.

(Press release, Kelun, AUG 17, 2026, View Source [SID1234670191])

On August 17, 2026 OncoC4 Inc., a late clinical-stage biopharmaceutical company developing novel medicines for cancer and neurodegenerative diseases, reported dosing of the first patient following the clearance of the Investigational New Drug (IND) application for a Phase 1 clinical trial (NCT07408258) of ONC-783, the company’s investigational T-cell engager developed based on the proprietary neoCD24 platform.

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"This milestone demonstrates OncoC4’s leading position in developing first-in-class cancer therapeutics," said Dr. Yang Liu, CEO and Chief Scientific Officer, "CD24 is expressed in nearly 70% of human cancers 1, and abnormal glycosylation in malignant cells produces the neoCD24 epitope that is largely absent from the normal tissues. By exploiting this cancer-specific epitope, ONC-783 is designed to maximize selectivity for tumor cells while minimizing the risk of on-target/off-tumor toxicity that has limited other T-cell engagers."

ONC-783 is the world’s first and only clinical stage T-cell engager targeting the cancer-specific glycoform of CD24 (neoCD24). The drug candidate is designed to address the limitations of existing immunotherapies by selectively targeting the tumor-specific epitope while redirecting T cells for potent anti-tumor activity. Preclinical studies have demonstrated broad anti-tumor activity for ONC-783 across multiple solid tumor and hematologic malignancies, including pancreatic cancer, lung cancer, breast cancer, colorectal cancer, ovarian cancer, glioblastoma, and mantle cell lymphoma, which supports the potential of ONC-783 as a treatment across multiple tumor types. In addition, a subcutaneous formulation was developed for ONC-783 to enable gradual systemic exposure and provide a potential safety advantage compared with intravenously administered T-cell engagers.

"We are extremely excited to partner with OncoC4 to explore the potential of targeting neoCD24 to bring clinical benefit for cancer patients with limited treatment options," added Dr. Aiwu Ruth He, Professor of Medicine and medical oncologist at Columbia University Irving Medical Center in New York City. "Advanced solid tumors remain a significant challenge, and this innovative mechanism offers a promising new approach for patients who have progressed or intolerant to standard therapy."

ONC-783 is being tested in ONC-783-001, a Phase 1 trial in the US for patients with advanced solid tumors. The first study patient was successfully dosed at Columbia University Irving Medical Center. The treatment was well tolerated. No severe Adverse Events, Cytokine Release Syndrome, or Immune Effector Cell-Associated Neurotoxicity Syndrome have been observed to date. OncoC4 will continue the innovation in cancer immunotherapy and remain committed to the development of first-in-class therapeutics to address the unmet needs in cancer treatments.

About ONC-783-001

ONC-783-001 is a Phase 1 open-label, dose-escalation study in the United States (U.S.) to evaluate the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer. OncoC4 has engaged several clinical centers across the U.S. to recruit patients for ONC-783-001 including Columbia University Irving Medical Center and The University of Texas MD Anderson Cancer Center. The clinical trial registration number is NCT07408258.

About the NeoCD24 Platform

CD24 is expressed in nearly 70% of human cancers1, along with a significant level of expression also in normal tissues, where it plays a key role in regular cell growth, tissue maintenance, and immune system function. Targeting CD24 as a cancer treatment has been challenging due to the lack of selectivity to tumor cells. OncoC4 has discovered that abnormal glycosylation in malignant cells produces the neoCD24 epitope, a tumor-specific antigen that is largely absent from normal tissues, enabling the development of cancer-specific therapeutics targeting CD24. OncoC4 is developing several first-in-class cancer treatments based on the neoCD24 platform.

(Press release, OncoC4, AUG 17, 2026, View Source [SID1234670190])