Artificial Intelligence-guided Prognostication and Cranial Radiotherapy Optimization in First-line Third-generation EGFR-TKI-treated EGFR-mutant Non-small Cell Lung Cancer With Baseline Brain Metastases: a Multicenter, Observational Study

The goal of this observational study is to extract the imaging features of brain lesions and primary lung lesions in NSCLC patients with brain metastases by deep learning, as well as common clinicopathological parameters, which are used to construct a multimode model that can accurately predict the treatment efficacy and survival of the third-generation EGFR-TKI treatment, and to use the model to assist in screening high-risk populations suitable for upfront cranial radiotherapy.
Participants receiving third-generation EGFR-TKI treatment will be enrolled in our study and we will collect their regular contrast-enhanced chest CT and contrast-enhanced brain MRI for model construction.

Start Date30 Sep 2024

Sponsor / Collaborator

Fudan University

CTR20243195 / RecruitingPhase 1

评估注射用 TQB2928 联合第三代 EGFR TKI 药物治疗晚期非小细胞肺癌的 Ib 期临床研究

[Translation] Phase Ib clinical study evaluating TQB2928 for injection combined with third-generation EGFR TKI drugs in the treatment of advanced non-small cell lung cancer

主要目的：评估注射用 TQB2928 联合第三代 EGFR TKI 在晚期非小细胞肺癌受试者中的安全性和耐受性，确定注射用 TQB2928 联合第三代 EGFR TKI 药物的 II 期推荐剂量（RP2CD）；评估注射用 TQB2928 联合第三代 EGFR TKI 在晚期非小细胞肺癌受试者中的初步有效性。次要目的：评估注射用 TQB2928 联合第三代 EGFR TKI 在晚期非小细胞肺癌受试者中的药代动力学（PK）特征和免疫原性。

[Translation]

Primary objective: To evaluate the safety and tolerability of TQB2928 for injection combined with third-generation EGFR TKI in subjects with advanced non-small cell lung cancer, determine the recommended Phase II dose (RP2CD) of TQB2928 for injection combined with third-generation EGFR TKI drugs; to evaluate the preliminary efficacy of TQB2928 for injection combined with third-generation EGFR TKI in subjects with advanced non-small cell lung cancer. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics and immunogenicity of TQB2928 for injection combined with third-generation EGFR TKI in subjects with advanced non-small cell lung cancer.

Start Date19 Sep 2024

Sponsor / Collaborator

Nanjing Shunxin Pharmaceutical Co., Ltd.

NCT06585059 / Not yet recruitingPhase 1

A Phase Ib Clinical Study of TQB2928 in Combination With a Third-Generation EGFR TKI in Patients With Advanced Non-Small Cell Lung Cancers

This is a Phase Ib study to evaluate the safety, tolerability, and efficacy of TQB2928 in combination with third-generation EGFR TKIs in subjects with advanced non-small cell lung cancer, and to determine the recommended Phase II dose (RP2CD).

Start Date01 Sep 2024

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Almonertinib Mesilate

100 Translational Medicine associated with Almonertinib Mesilate

100 Patents (Medical) associated with Almonertinib Mesilate

Literatures (Medical) associated with Almonertinib Mesilate

31 Dec 2024·PHARMACEUTICAL BIOLOGY

Optimization of a sensitive and reliable UPLC-MS/MS method to simultaneously quantify almonertinib and HAS-719 and its application to study the interaction with nicardipine

Article

Author: Shen, Yuxin ; Chen, Dongxin ; Chen, Xiaohai ; Liu, Ya-nan ; Xia, Hailun ; Chen, Jie ; Xu, Ren-ai

CONTEXT:

Almonertinib is primarily metabolized by CYP3A4, so it could interact with a variety of drugs metabolized by CYP3A4, leading to the changes of systemic exposure.

OBJECTIVE:

For the purpose of this experiment, an ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) assay with accuracy and simplicity was optimized and fully validated for the simultaneous quantitative determination of almonertinib and its metabolite HAS-719, and drug-drug interactions (DDI) between almonertinib and nicardipine in vivo and in vitro was researched.

MATERIALS AND METHODS:

Detection of analytes was achieved by UPLC-MS/MS coupled with multiple reaction monitoring (MRM) in the positive ion mode with ion transitions of m/z 526.01 → 72.04 for almonertinib, m/z 512.18 → 455.08 for HAS-719 and m/z 447.16 → 128.11 for IS, respectively.

RESULTS:

There was favourable linearity in the 0.5-200 ng/mL calibration range for almonertinib and 0.5-100 ng/mL for HAS-719. The lower limit of quantification (LLOQ) for both analytes was 0.5 ng/mL. The precision, accuracy, stability, matrix effect and extraction recovery required for methodological validation were consistent with the requirements of FDA guideline. Then, the UPLC-MS/MS assay was employed successfully on the interactions of almonertinib and nicardipine in vivo and in vitro. The half-maximal inhibitory concentration (IC₅₀) was 1.19 μM in rat liver microsomes (RLM), where nicardipine inhibited the metabolism of almonertinib with a mixed inhibitory mechanism. In pharmacokinetic experiments of rats, it was observed that nicardipine could significantly alter the pharmacokinetic profiles of almonertinib, including AUC_(0-∞), AUC_(0-t) and C_max, but had no effect on the metabolism of HAS-719.

CONCLUSION:

According to the findings, it was indicated that nicardipine could inhibit the metabolism of almonertinib in vitro and in vivo.

01 Dec 2024·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Simultaneous determination of icotinib, osimertinib, aumolertinib, and anlotinib in human plasma for therapeutic drug monitoring by UPLC-MS/MS

Article

Author: Gao, Jinglin ; Zhao, Haopeng ; Xu, Yuxiang ; Wang, Mingxia ; Gao, Xiaonan ; Bai, Jing ; Qie, Hongxin ; Feng, Zhangying

Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) such as icotinib, osimertinib, and aumolertinib have emerged as promising treatment options for EGFR mutated Non-small cell lung cancer (NSCLC) patients. Additionally, anlotinib, an anti-angiogenic agent targeting VEGFR, FGFR, and PDGFR, has been used in combination with EGFR-TKIs in NSCLC cases. A method utilizing ultrahigh performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) was developed and validated for quantifying icotinib, osimertinib, aumolertinib and anlotinib simultaneously in clinical TDM. The chromatographic separation was performed using a Kinetex C18 column (100 mm × 2.1 mm) and an elution gradient of ammonium acetate in water acidified with 0.1 % formic acid and in acetonitrile. The assay was validated over a linear range of 4-2000 ng/mL for icotinib, 2-1000 ng/mL for osimertinib, 1-500 ng/mL for aumolertinib, and 0.8-400 ng/mL for anlotinib, following the guidelines on bioanalytical methods by FDA. The quantification method exhibited satisfactory performance in terms of selectivity, accuracy (from 91.3 % to 107 %), precision (intra- and inter-day coeffficients of variation ranged from 0.944 % to 7.48 %), linearity, recovery (from 86.0 % to 91.9 %), matrix effect (IS-normalized matrix factors were from 96.7 % to 102 %), and stability. Overall, the method proved to be sensitive, reliable, and straightforward, enabling successful simultaneous determination of blood concentrations of icotinib, osimertinib, aumolertinib, and anlotinib in patients. The validity of the method has been confirmed across various instruments.

01 Nov 2024·CTS-Clinical and Translational Science

Serum creatine kinase elevation following tyrosine kinase inhibitor treatment in cancer patients: Symptoms, mechanism, and clinical management

Review

Author: To, Kenneth K. W. ; Zhang, Hang

Abstract:

Molecular targeted tyrosine kinase inhibitors (TKIs) have produced unprecedented treatment response in cancer therapy for patients harboring specific oncogenic mutations. While the TKIs are mostly well tolerated, they were reported to increase serum levels of creatine kinase (CK) and cause muscle metabolism‐related toxicity. CK is an essential enzyme involved in cellular energy metabolism and muscle function. Elevated serum CK levels can arise from both physiological and pathological factors, as well as triggered by specific drug classes. The incidence of serum CK elevation induced by a few approved TKIs (brigatinib, binimetinib, cobimetinib‐vemurafenib combination [Food and Drug Administration, United States]; aumolertinib, and sunvozertinib [only approved by National Medical Products Administration, China]) were over 35%. CK elevation‐related symptoms include myopathy, myositis, inclusion body myositis (IBM), cardiotoxicity, rhabdomyolysis, rash, and acneiform dermatitis. High‐level or severe symptomatic CK elevation may necessitate dose reduction and indirectly dampen TKI efficacy. This review presents an updated summary about the prevalence rate and recent research about mechanisms leading to TKI‐induced serum CK elevation in cancer patients. The utility of monitoring serum CK levels for predicting TKI‐induced adverse effects and their management will also be discussed.

News (Medical) associated with Almonertinib Mesilate

30 Oct 2024

·www.biospace.com

10 Years of NextGen Honorees: Where Are They Now?

iStock, leolintang BioSpace has been compiling a list of the most innovative and exciting biotechs for a decade. Here we take a look back at noteworthy companies from each of those lists. 2024 marked the 10th year of BioSpace ’s NextGen list, a collection of biotechs that are on the cutting edge and poised to break barriers in the industry. As we prep next year’s list, to be released in January, we decided to take a look back at a notable honoree from each of our past lists. There were many fascinating companies that have gone on to great things; on the other hand, sometimes things don’t go as well as we predicted. We have a few not-so-great stories to tell, too. ___________________________________________ 2024 ReNAgade Therapeutics Status: Bought by Orna Therapeutics This company made our list for a pretty big reason: a massive $300 million series A in one of the toughest financing environments in recent memory. The company was launched in May 2023 to develop RNA medicines to treat diseases anywhere in the body. One of the lead investors in the round was MPM BioImpact, whose managing partner Ansbert Gadicke founded ReNAgade. Early in the biotech’s history as a stealth company, there was a bit of foreshadowing as to where the company would end up. ReNAgade struck up a partnership with Orna Therapeutics, which was also working on RNA therapeutics. The work attracted the attention of Merck in a deal worth up to $3.5 billion with development and commercialization milestones. Given the money on the line, Orna went all in on ReNAgade, buying out the biotech in May of this year—almost a year to the day after its launch. Financial details were not disclosed. See the full class of 2024 . ___________________________________________ 2023 Mariana Oncology Status: Bought by Novartis What a year 2023 turned out to be for Mariana Oncology. After raising a $175 million series B in September of that year, the company was bought out by Novartis for $1 billion , plus $750 million in milestones. Originally known as Curie Therapeutics, Mariana emerged from stealth with a $75 series A raise in December 2021 to develop new radiopharmaceuticals. The company caught our eye and made the 2023 list, but apparently Novartis was keeping an eye too. The radiopharmaceutical-hungry Big Pharma said at the time of the deal that Mariana’s technology would help it double down in the field of radioligand therapeutics. On a recent earnings call, Novartis executives expressed their excitement in the Mariana technology, saying that candidates from the buyout are speeding toward the clinic and could go after well-established antibody-drug conjugate (ADC) targets. See the full class of 2023 . ___________________________________________ 2022 Eikon Therapeutics Status: Operating Eikon has spent the two years since landing on our list racking up cash and poaching executives from CEO Rodger Perlmutter’s former employer Merck. The biotech’s raises have been huge in a really tough market: a $148 million series A in May 2021, $518 million for a January 2022 series B and most recently, $106 million in series C financing in June 2023 . At the most recent raise, Eikon also announced the acquisition of a clinical pipeline. The company now boasts oncology assets in Phase I and II testing for non-small cell lung cancer and melanoma, respectively. The rest of Eikon’s pipeline is in preclinical research or discovery. See the full class of 2022 . ___________________________________________ 2021 EQRx Status: Bought by Revolution Medicines, assets terminated EQRx emerged with a lofty goal we could all get behind: develop drugs at a lower cost. It raised a cool $200 million in a July 2020 series A, then caught the special purpose acquisition company (SPAC) wave to the Nasdaq just over a year later, adding $1.8 billion in an August 2021 IPO. The company was helmed at first by serial biotech entrepreneur Alexis Borisy. Trouble emerged shortly thereafter, with EQRx cutting lead asset sugemalimab for NSCLC after determining it had no path to market. The company shifted to two other assets, aumolertinib and lerociclib, but later dropped the former. Several rounds of layoffs made the company ever smaller before EQRx finally gave up entirely. The assets were terminated as Revolution Medicines bought out the company and its hefty $1 billion bank account. Borisy has since gone on to start a venture capital firm called Curie.Bio . See the full class of 2021 . ___________________________________________ 2020 Cerevel Therapeutics Status: Bought by AbbVie Cerevel as a company is no more, but its medicines live on at AbbVie, which bought the biotech for $8.7 billion in December 2023. The deal was part of a trend of neuroscience-focused biotechs being bought up by Big Pharma, with Cerevel moving in the same month as Bristol Myers Squibb bought Karuna Therapeutics for $14 billion. BMS was rewarded quickly with a recent FDA approval for KarXT (now Cobenfy) for schizophrenia, but AbbVie too has had success since sealing the deal. Cerevel’s investigational Parkinson’s disease therapy tavapadon improved control of motor symptoms when used with common treatment levodopa in a Phase III trial that read out in April. The data would support a regulatory filing for the therapy, executives said at the time. Two additional late-stage readouts for the therapy are due later this year. But the real star of the deal was emraclidine, which is in Phase III studies for schizophrenia. Cerevel also brought a major depression treatment to the table. “These assets clearly will be great additions to our neuroscience franchise,” said AbbVie’s CEO Rob Michael on the company’s second quarter earnings call. See the full class of 2020 . ___________________________________________ 2019 Genevant Status: Operating One of Roivant’s offshoots, Genevant is still operating today, working on developing nucleic acid delivery technology. Just last week, Genevant signed a deal with CRISPR gene editing company Editas Medicines to develop in vivo gene editing medicines for two undisclosed targets. Genevant has also recently signed deals with Novo Nordisk, Tome Biosciences, Gritstone bio and Repair Biotechnologies. But perhaps the most compelling story from Genevant since we named them to our NextGen list has been their litigation with famed biotech Moderna over the lipid nanoparticle delivery system used for its approved COVID-19 vaccine. Genevant and Arbutus Biopharma filed several patent infringement claims against Moderna arguing that the vaccine developer used their technology without license or proper compensation. A judge sided with Arbutus and Genevant in April, with a trial set for next year. See the full class of 2019 . ___________________________________________ 2018 BlueRock Therapeutics Status: Bought by Bayer Bayer bought cell therapy biotech BlueRock Therapeutics in August 2019 for $1 billion, but rather than absorbing the company into itself, the German pharma kept the name and unit operating. This unusual but refreshing strategy means that the company essentially lives on. In June 2023, BlueRock reported that Parkinson’s disease stem cell therapy bemdaneprocel was well tolerated with no significant side effects in a Phase I trial with 12 patients. It was the first cell therapy to show positive results in human testing, Bayer said at the time. A September update showed similar safety results. The therapy has since received a regenerative medicine advanced therapy tag from the FDA. Elsewhere in the pipeline, BlueRock’s investigational iPSC-derived cell therapy OpCT-001 for certain retinal disorders was cleared for human testing in September. The therapy was licensed from FUJIFILM Cellular Dynamics and Opsis Therapeutics. See the full class of 2018 . ___________________________________________ 2017 Decibel Therapeutics Status: Bought by Regeneron Regeneron made a splash at this year’s American Society of Gene and Cell Therapy meeting in Baltimore when it showcased results of a Phase I/II trial of hearing loss therapy DB-OTO. The therapy restored hearing in two children who had a genetic form of hearing loss. While Regeneron’s branding was behind the conference presentation, the gene therapy came from Decibel Therapeutics. Regeneron bought the biotech for $109 million in August 2023, at which point the two companies had already been working together for six years. The biotech was integrated into Regeneron’s genetic medicines portfolio. See the full class of 2017 . ___________________________________________ 2016 CRISPR Therapeutics Status: Operating CRISPR Therapeutics made history last year as the first company, along with partner Vertex Pharmaceuticals, to gain an FDA approval for a CRISPR-based gene edited therapy. The companies were granted an FDA greenlight for Casgevy in sickle cell disease. The same day, bluebird bio got a similar nod for a competing gene therapy, though not one that involves CRISPR technology. The FDA approval was a triumph of modern biotechnology. But the roll out has been slow given the nature of gene therapy treatment, and only recently have patients begun receiving infusions of the medicine. Casgevy is now also approved for beta thalassemia, another blood disorder. The company has turned to the rest of its pipeline, including a CD19-directed CAR T cell program called CTX112, which is being tested in both cancer and autoimmune disorders. CTX131 is in development for hematological malignancies as well. CEO Sam Kulkarni has expressed confidence in CRISPR’s leading position in gene editing and pledged to be on top of emerging technologies. “One of the most important considerations for us is that we don’t get disrupted,” he said at the Goldman Sachs healthcare conference in June. “We are the leaders in the gene editing space and we have been, but we want to make sure that we’re looking at every improvement that’s coming out there.” See the full class of 2016 . ___________________________________________ 2015 Spark Therapeutics Status: Bought by Roche Like BlueRock, Spark Therapeutics was folded into a Big Pharma but kept its identity. Spark earned a spot on our very first NextGen list in 2015 thanks to its active clinical hemophilia program and fundraises totaling $122.8 million. The company caught the eye of Roche, which swooped in with a $4.8 billion bid in February 2019. The deal eventually turned into a bit of a boondoggle, with regulatory delays slowing things down until it finally closed that December. At issue was Roche’s hemophilia Hemlibra. Regulators worried that Spark’s hemophilia program and Hemlibra together could stifle competition and create a monopoly. Spark brought with it the approved eye disease gene therapy Luxturna. With the deal closed, Spark has charged forward under the Roche banner. The unit is developing a 500,000-square foot Gene Therapy Innovation Center in Philadelphia as its flagship manufacturing space. See the full class of 2015 .

Phase 1AcquisitionPhase 3Drug Approval

17 Sep 2024

·www.businesswire.com

Patritumab Deruxtecan Demonstrated Statistically Significant Improvement in Progression-Free Survival Versus Doublet Chemotherapy in Patients with Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer in HERTHENA-Lung02 Phase 3 Trial

BASKING RIDGE, N.J. & RAHWAY, N.J.--( BUSINESS WIRE )--The HERTHENA-Lung02 phase 3 trial evaluating patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement versus platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy. Overall survival (OS) data were immature at the time of the analysis and the trial will continue to further assess OS, a secondary endpoint. Patritumab deruxtecan is a specifically engineered potential first-in-class HER3 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and Merck (NYSE: MRK), known as MSD outside of the United States and Canada. NSCLC accounts for approximately 85% of all lung cancers worldwide with up to 70% of NSCLC cases diagnosed at an advanced stage and EGFR-activating mutations occur in 14% to 38% of all NSCLC tumors worldwide. 1,2,3 Following initial treatment for metastatic EGFR-mutated NSCLC with an EGFR TKI, many patients experience disease progression and currently available therapies in the second-line setting are limited, highlighting the need for new approaches to improve outcomes. 3,4 Data from the HERTHENA-Lung02 trial will be presented at an upcoming medical meeting and shared with global regulatory authorities. “ These results from HERTHENA-Lung02 demonstrate the potential of patritumab deruxtecan to become an important treatment option for certain patients with EGFR-mutated non-small cell lung cancer with prior tyrosine kinase inhibitor treatment,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “ We plan to share these findings with regulatory authorities to discuss next steps.” “ We are encouraged by these results demonstrating a statistically significant progression-free survival improvement compared to platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who received prior tyrosine kinase inhibitor treatment,” said Marjorie Green, MD, Senior Vice President and Head of Oncology, Global Clinical Development, Merck Research Laboratories. “ Together with Daiichi Sankyo, we are committed to helping patients with previously treated EGFR-mutated non-small cell lung cancer, where there is a high unmet need.” The safety profile seen in HERTHENA-Lung02 was consistent with that observed for patritumab deruxtecan in previous lung cancer clinical trials with no new safety signals identified. The majority of interstitial lung disease (ILD) events were low grade (grade 1 and 2). There were two grade 5 ILD events observed. About HERTHENA-Lung02 HERTHENA-Lung02 is a global, multicenter, open-label, phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan (5.6 mg/kg every three weeks) versus four cycles of pemetrexed and platinum chemotherapy in patients with metastatic or locally advanced NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R) after failure of third-generation (e.g., osimertinib, lazertinib, aumolertinib, alflutinib) EGFR TKI therapy. Patients in the comparator arm without disease progression after four cycles of pemetrexed and platinum chemotherapy are able to continue treatment with maintenance pemetrexed with no restriction on the number of cycles. The primary endpoint of HERTHENA-Lung02 was PFS as assessed by blinded independent central review (BICR). Secondary endpoints included OS, objective response rate, duration of response, clinical benefit rate, time to response, disease control rate, and safety. Patients enrolled in the study underwent brain imaging to allow for assessment of intracranial endpoints, including intracranial PFS as assessed by BICR. HERTHENA-Lung02 enrolled 586 patients in Asia, Europe, North America and Oceania. For more information about the trial, visit ClinicalTrials.gov . About EGFR-Mutated Non-Small Cell Lung Cancer Nearly 2.5 million lung cancer cases were diagnosed globally in 2022. 5 Lung cancer is the most common cancer and the leading cause of cancer-related deaths worldwide. 5 Approximately 85% of lung cancer is classified as NSCLC with EGFR-activating mutations occurring in 14% to 38% of all NSCLC tumors worldwide. 1,3 NSCLC is diagnosed at an advanced stage in up to 70% of patients and often has a poor prognosis with worsening outcomes after each line of subsequent therapy. 2,6 Following initial treatment for metastatic EGFR-mutated NSCLC with an EGFR TKI, many patients experience disease progression and currently available therapies in the second-line setting are limited, highlighting the need for new approaches to improve outcomes. 3,4 About HER3 HER3 is a member of the HER family of receptor tyrosine kinases. 7 It is estimated that about 83% of primary NSCLC tumors and 90% of advanced EGFR-mutated tumors express HER3 after prior EGFR TKI treatment. 8 HER3 is associated with poor treatment outcomes, including shorter relapse-free survival and significantly reduced survival. 9,10 There is currently no HER3 directed therapy approved for the treatment of any cancer. About Patritumab Deruxtecan Patritumab deruxtecan (HER3-DXd) is an investigational HER3 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, patritumab deruxtecan is composed of a fully human anti-HER3 IgG1 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. Patritumab deruxtecan is currently being evaluated as both a monotherapy and in combination with other therapies in a global development program, which includes HERTHENA-Lung02 , a phase 3 trial evaluating the efficacy and safety of patritumab deruxtecan versus pemetrexed plus platinum chemotherapy in patients with EGFR-mutated locally advanced or metastatic NSCLC following disease progression on or after treatment with a third-generation EGFR TKI; HERTHENA-Lung01 , a phase 2 trial in metastatic or locally advanced NSCLC with an activating EGFR mutation previously treated with at least one EGFR TKI and one platinum-based chemotherapy-containing regimen; HERTHENA-PanTumor01 , a phase 2 trial in 10 locally advanced or metastatic solid tumor types, including melanoma, gastric and head and neck cancer, among other types of cancer, previously treated with at least one prior systemic therapy; a phase 1 trial in combination with osimertinib in EGFR-mutated locally advanced or metastatic NSCLC; and a phase 1 trial in previously treated patients with advanced NSCLC. A phase 1/2 trial in HER3 expressing metastatic breast cancer also has been completed. About the Daiichi Sankyo and Merck Collaboration Daiichi Sankyo and Merck entered into a global collaboration in October 2023 to jointly develop and commercialize patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd) and raludotatug deruxtecan (R-DXd), except in Japan where Daiichi Sankyo will maintain exclusive rights. Daiichi Sankyo will be solely responsible for manufacturing and supply. In August 2024 , the global co-development and co-commercialization agreement was expanded to include MK-6070 which they will jointly develop and commercialize worldwide, except in Japan where Merck will maintain exclusive rights. Merck will be solely responsible for manufacturing and supply for MK-6070. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Datopotamab deruxtecan, ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical needs. For more information, please visit www.daiichisankyo.com . Merck’s Focus on Cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology/ . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). _______________________________ References: 1 Economopoulou P, et al. Ann Transl Med . 2018; 6(8):138. 2 Guo H, et al. Front Oncol . 2021; 11: 761042. 3 Pretelli G, et al. Int J Mol Sci . 2023; 24, 8878. 4 Janne PA, et al. Cancer Discov . 2022; 12(1):74-89. 5 World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet . Accessed July 2024. 6 Hardstock F, et al. BMC Cancer . 2020; 20(1):260. 7 Mishra R, et al. Onco Rev . 2018; 12(355):45-62. 8 Scharpenseel H, et al. Scientific Reports . 2019; 9:7406. 9 Gandullo-Sánchez L et al. J Exp Clin Cancer Res . 2022; 41:310. 10 Yu H.A., et al. Annals of Oncology . 2024; 35(5): P437-447.

Phase 3Clinical ResultPhase 1License out/inADC

23 Aug 2024

·www.globenewswire.com

Burning Rock Reports Second Quarter 2024 Financial Results

GUANGZHOU, China, Aug. 22, 2024 (GLOBE NEWSWIRE) -- Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”), a company focused on the application of next generation sequencing (NGS) technology in the field of precision oncology, today reported financial results for the three months ended June 30, 2024. Recent Business Updates Therapy Selection Presented study results on small-cell lung cancer and colorectal cancer at the ASCO in June 2024. “The efficacy and safety of high dose Almonertinib in untreated EGFR-mutated NSCLC with brain metastases, including biomarker analysis” and “Individualized tumor-informed circulating tumor DNA analysis for molecular residual disease detection in predicting recurrence and efficacy of adjuvant chemotherapy in colorectal cancer”. Pharma Services New companion diagnostics (CDx) collaboration announced with Bayer in China. Second Quarter 2024 Financial Results Total Revenues were RMB135.5 million (US$18.7 million) for the three months ended June 30, 2024, representing a 7.3% decrease from RMB146.3 million for the same period in 2023, as we transition from central-lab to more in-hospital based testing. Importantly, in-hospital segment continued its double-digit growth. Revenue generated from in-hospital business was RMB59.9 million (US$8.2 million) for the three months ended June 30, 2024, representing a 11.2% increase from RMB53.8 million for the same period in 2023, driven by an increase in sales volume.Revenue generated from central laboratory business was RMB48.8 million (US$6.7 million) for the three months ended June 30, 2024, representing a 26.4% decrease from RMB66.2 million for the same period in 2023, primarily attributable to a decrease in the number of tests, as we continued our transition towards in-hospital testing.Revenue generated from pharma research and development services was RMB26.9 million (US$3.7 million) for the three months ended June 30, 2024, representing a 2.6% increase from RMB26.2 million for the same period in 2023, primarily attributable to an increased development and testing services performed for our pharma customers. Cost of revenues was RMB40.1 million (US$5.5 million) for the three months ended June 30, 2024, representing an 12.5% decrease from RMB45.8 million for the same period in 2023, primarily due to (i) a decrease in cost of central laboratory business, which was in line with the decrease in revenue generated from this business; and (ii) a decrease in amortization expense for all kinds of business. Gross profit was RMB95.4 million (US$13.1 million) for the three months ended June 30, 2024, representing a 5.0% decrease from RMB100.4 million for the same period in 2023. Gross margin was 70.4% for the three months ended June 30, 2024, compared to 68.7% for the same period in 2023. By channel, gross margin of central laboratory business was 78.8% for the three months ended June 30, 2024, compared to 78.3% during the same period in 2023; gross margin of in-hospital business was 73.6% for the three months ended June 30, 2024, compared to 62.0% during the same period in 2023, primarily due to a decrease in amortization; gross margin of pharma research and development services was 48.2% for the three months ended June 30, 2024, compared to 58.0% during the same period of 2023, primarily due to a decrease in test volume of higher margin projects. Non-GAAP gross profit, which excludes depreciation and amortization expenses, was RMB101.9 million (US$14.0 million) for the three months ended June 30, 2024, representing a 6.8% decrease from RMB109.4 million for the same period in 2023. Non-GAAP gross margin was 75.2% for the three months ended June 30, 2024, compared to 74.8% for the same period in 2023. Operating expenses were RMB206.7 million (US$28.4 million) for the three months ended June 30, 2024, representing a 12.5% decrease from RMB236.1 million for the same period in 2023. The decrease was primarily driven by budget control measures and headcount reduction to improve the Company’s operating efficiency. Research and development expenses were RMB65.0 million (US$8.9 million) for the three months ended June 30, 2024, representing a 32.2% decrease from RMB95.8 million for the same period in 2023, primarily due to (i) a decrease in staff cost resulted from the reorganization of our research and development department to improve operating efficiency; (ii) a decrease in the expenditure for research projects; and (iii) a decrease in amortized expenses for office building decoration.Selling and marketing expenses were RMB48.9 million (US$6.7 million) for the three months ended June 30, 2024, representing a 31.0% decrease from RMB70.8 million for the same period in 2023, primarily due to (i) a decrease in staff cost resulted from the reorganization of the sales department and improvement in operating efficiency; (ii) a decrease in conference fee; and (iii) a decrease in travel expense.General and administrative expenses were RMB92.8 million (US$12.8 million) for the three months ended June 30, 2024, representing a 33.5% increase from RMB69.5 million for the same period in 2023, primarily due to an increase in amortized expense on share-based compensation. Net loss was RMB108.0 million (US$14.9 million) for the three months ended June 30, 2024, compared to RMB131.2 million for the same period in 2023. Cash, cash equivalents, restricted cash and short-term investments were RMB533.0 million (US$73.3 million) as of June 30, 2024. About Burning Rock Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage. For more information about Burning Rock, please visit: ir.brbiotech.com. Safe Harbor Statement This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “target,” “confident” and similar statements. Burning Rock may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about Burning Rock’s beliefs and expectations, are forward-looking statements. Such statements are based upon management’s current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Burning Rock’s control. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. All information provided in this press release is as of the date of this press release, and Burning Rock does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law. Non-GAAP Measures In evaluating the business, the Company considers and uses non-GAAP measures, such as non-GAAP gross profit and non-GAAP gross margin, as supplemental measures to review and assess operating performance. The presentation of these non-GAAP financial measures is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The company defines non-GAAP gross profit as gross profit excluding depreciation and amortization. The company defines non-GAAP gross margin as gross margin excluding depreciation and amortization. The company presents these non-GAAP financial measures because they are used by management to evaluate operating performance and formulate business plans. The company believe non-GAAP gross profit and non-GAAP gross margin excluding non-cash impact of depreciation and amortization reflect the company’s ongoing business operations in a manner that allows more meaningful period-to-period comparisons. Contact: IR@brbiotech.com Selected Operating Data As of June 30,2023 September 30, 2023 December 31, 2023 March 31, 2024 June 30, 2024 In-hospital Channel: Pipeline partner hospitals(1)30 29 28 28 29 Contracted partner hospitals(2)50 55 59 59 59 Total number of partner hospitals 80 84 87 87 88 (1) Refers to hospitals that are in the process of establishing in-hospital laboratories, laboratory equipment procurement or installation, staff training or pilot testing using the Company’s products.(2) Refers to hospitals that have entered into contracts to purchase the Company’s products for use on a recurring basis in their respective in-hospital laboratories the Company helped them establish. Kit revenue is generated from contracted hospitals. Selected Financial Data For the three months ended RevenuesJune 30, 2023 September 30, 2023 December 31, 2023 March 31, 2024 June 30, 2024 (RMB in thousands)Central laboratory channel66,239 53,481 51,288 47,614 48,773 In-hospital channel53,835 54,496 28,809 57,387 59,872 Pharma research and development channel26,194 19,589 40,988 20,622 26,888 Total revenues146,268 127,566 121,085 125,623 135,533 For the three months ended Gross profit June 30, 2023 September 30, 2023 December31, 2023 March 31, 2024 June 30, 2024 (RMB in thousands)Central laboratory channel51,876 41,487 41,886 37,002 38,424 In-hospital channel33,353 35,459 12,910 39,192 44,058 Pharma research and development channel15,193 8,974 23,317 9,500 12,956 Total gross profit100,422 85,920 78,113 85,694 95,438 For the three months endedShare-based compensation expensesJune 30,2023 September 30, 2023 December31, 2023 March 31, 2024 June 30, 2024 (RMB in thousands) Cost of revenues627 680 654 596 464 Research and development expenses15,301 12,161 12,401 12,287 12,008 Selling and marketing expenses3,389 2,848 1,816 508 1,232 General and administrative expenses18,502 57,704 56,472 55,990 54,407 Total share-based compensation expenses 37,819 73,393 71,343 69,381 68,111 Burning Rock Biotech Limited Unaudited Condensed Statements of Comprehensive Loss (in thousands, except for number of shares and per share data) For the three months ended June 30, 2023 September 30, 2023 December 31,2023 March 31, 2024 June 30, 2024 June 30, 2024 RMBRMB RMB RMB RMB US$ Revenues146,268 127,566 121,085 125,623 135,533 18,650 Cost of revenues(45,846) (41,646) (42,972) (39,929) (40,095) (5,517) Gross profit100,422 85,920 78,113 85,694 95,438 13,133 Operating expenses: Research and development expenses(95,779) (83,701) (73,119) (65,985) (64,952) (8,938) Selling and marketing expenses(70,842) (62,310) (49,785) (46,856) (48,907) (6,730) General and administrative expenses(69,525) (118,724) (121,533) (98,681) (92,794) (12,769) Total operating expenses(236,146) (264,735) (244,437) (211,522) (206,653) (28,437) Loss from operations (135,724) (178,815) (166,324) (125,828) (111,215) (15,304) Interest income5,255 4,018 5,539 4,038 3,187 439 Other income (expense), net(118) (157) 160 434 (82) (11) Foreign exchange (loss) gain, net（210) 423 (517) (13) 262 36 Loss before income tax(130,797) (174,531) (161,142) (121,369) (107,848) (14,840) Income tax expenses(445) (450) (1,071) (180) (190) (26) Net loss(131,242) (174,981) (162,213) (121,549) (108,038) (14,866) Net loss attributable to Burning Rock Biotech Limited’s shareholders(131,242) (174,981) (162,213) (121,549) (108,038) (14,866) Net loss attributable to ordinary shareholders(131,242) (174,981) (162,213) (121,549) (108,038) (14,866) Loss per share for class A and class B ordinary shares: Class A ordinary shares - basic and diluted(1.28) (1.71) (1.58) (1.19) (1.05) (0.14) Class B ordinary shares - basic and diluted(1.28) (1.71) (1.58) (1.19) (1.05) (0.14) Weighted average shares outstanding used in loss per share computation: Class A ordinary shares - basic and diluted85,151,052 85,000,869 85,071,360 85,219,188 85,271,858 85,271,858 Class B ordinary shares - basic and diluted17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 17,324,848 Other comprehensive income (loss), net of tax of nil: Foreign currency translation adjustments14,829 (1,955) (3,026) 590 940 129 Total comprehensive loss(116,413) (176,936 ) (165,239) (120,959 ) (107,098) (14,737) Total comprehensive loss attributable to Burning Rock Biotech Limited’s shareholders(116,413) (176,936) (165,239) (120,959 ) (107,098) (14,737) Burning Rock Biotech Limited Unaudited Condensed Statements of Comprehensive Loss (in thousands, except for number of shares and per share data) For the six months ended June 30, 2023 June 30, 2024 June 30, 2024 RMB RMB US$ Revenues288,784 261,156 35,937 Cost of revenues(89,590) (80,024) (11,012) Gross profit199,194 181,132 24,925 Operating expenses: Research and development expenses(190,196) (130,937) (18,018) Selling and marketing expenses(135,616) (95,763) (13,177) General and administrative expenses(197,564) (191,475) (26,349) Total operating expenses(523,376) (418,175) (57,544) Loss from operations (324,182) (237,043) (32,619) Interest income8,399 7,225 994 Other income, net481 352 48 Foreign exchange loss, net(326) 249 34 Loss before income tax(315,628) (229,217) (31,543) Income tax expenses(867) (370) (51) Net loss(316,495) (229,587) (31,594) Net loss attributable to Burning Rock Biotech Limited’s shareholders(316,495) (229,587) (31,594) Net loss attributable to ordinary shareholders(316,495) (229,587) (31,594) Loss per share for class A and class B ordinary shares: Class A ordinary shares - basic and diluted(3.09) (2.24) (0.31) Class B ordinary shares - basic and diluted(3.09) (2.24) (0.31) Weighted average shares outstanding used in loss per share computation: Class A ordinary shares - basic and diluted85,108,555 85,246,969 85,246,969 Class B ordinary shares - basic and diluted17,324,848 17,324,848 17,324,848 Other comprehensive income (loss), net of tax of nil: Foreign currency translation adjustments9,170 1,530 211 Total comprehensive loss(307,325) (228,057) (31,383) Total comprehensive loss attributable to Burning Rock Biotech Limited’s shareholders(307,325) (228,057) (31,383) Burning Rock Biotech LimitedUnaudited Condensed Consolidated Balance Sheets(In thousands) As of December 31, 2023 June 30,2024 June 30,2024 RMB RMB US$ ASSETS Current assets: Cash and cash equivalents615,096 532,542 73,280 Restricted cash120 505 69 Accounts receivable, net126,858 153,641 21,142 Contract assets, net22,748 20,018 2,755 Inventories, net69,020 65,805 9,056 Prepayments and other current assets, net50,254 28,460 3,916 Convertible note receivable- 5,320 732 Total current assets 884,096 806,291 110,950 Non-current assets: Equity method investment337 247 34 Convertible note receivable5,320 - - Property and equipment, net131,912 100,716 13,860 Operating right-of-use assets12,284 105,429 14,508 Intangible assets, net964 724 100 Other non-current assets5,088 9,976 1,372 Total non-current assets 155,905 217,092 29,874 TOTAL ASSETS 1,040,001 1,023,383 140,824 Burning Rock Biotech LimitedUnaudited Condensed Consolidated Balance Sheets (Continued)(in thousands) As of December 31, 2023 June 30,2024 June 30,2024 RMB RMBUS$LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable18,061 25,870 3,560 Deferred revenue130,537 119,352 16,423 Accrued liabilities and other current liabilities104,935 86,300 11,876 Customer deposits1,197 1,197 165 Current portion of operating lease liabilities8,634 26,922 3,705 Total current liabilities 263,364 259,641 35,729 Non-current liabilities: Non-current portion of operating lease liabilities3,690 80,988 11,144 Other non-current liabilities4,537 4,908 676 Total non-current liabilities 8,227 85,896 11,820 TOTAL LIABILITIES 271,591 345,537 47,549 Shareholders’ equity: Class A ordinary shares116 116 16 Class B ordinary shares21 21 3 Additional paid-in capital4,849,337 4,986,830 686,211 Treasury stock(65,896) (65,896) (9,068) Accumulated deficits(3,853,635) (4,083,222) (561,870) Accumulated other comprehensive loss(161,533) (160,003) (22,017) Total shareholders’ equity768,410 677,846 93,275 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY1,040,001 1,023,383 140,824 Burning Rock Biotech LimitedUnaudited Condensed Statements of Cash Flows(in thousands) For the three months ended June 30, 2023 June 30,2024 June 30,2024 RMBRMBUS$Net cash used in operating activities(79,204) (40,836) (5,619) Net cash used in investing activities(2,928) (227) (31) Net cash used in financing activities(1,003) - - Effect of exchange rate on cash, cash equivalents and restricted cash13,271 1,436 196 Net decrease in cash, cash equivalents and restricted cash (69,864) (39,627) (5,454) Cash, cash equivalents and restricted cash at the beginning of period803,142 572,674 78,803 Cash, cash equivalents and restricted cash at the end of period733,278 533,047 73,349 For the six months ended June 30,2023 June 30,2024 June 30,2024 RMBRMBUS$Net cash used in operating activities(192,347) (81,045) (11,152) Net cash used in investing activities(6,987) (2,613) (360) Net cash used in financing activities(1,035) - - Effect of exchange rate on cash, cash equivalents and restricted cash8,379 1,489 204 Net decrease in cash, cash equivalents and restricted cash (191,990) (82,169) (11,308) Cash, cash equivalents and restricted cash at the beginning of period925,268 615,216 84,657 Cash, cash equivalents and restricted cash at the end of period733,278 533,047 73,349 Burning Rock Biotech LimitedReconciliations of GAAP and Non-GAAP Results For the three months ended June 30,2023 September 30, 2023 December 31, 2023 March 31,2024 June 30,2024 (RMB in thousands)Gross profit: Central laboratory channel51,876 41,487 41,886 37,002 38,424 In-hospital channel33,353 35,459 12,910 39,192 44,058 Pharma research and development channel15,193 8,974 23,317 9,500 12,956 Total gross profit100,422 85,920 78,113 85,694 95,438 Add: depreciation and amortization: Central laboratory channel2,645 2,550 2,414 1,919 1,226 In-hospital channel2,637 2,751 2,728 1,524 824 Pharma research and development channel3,665 3,863 3,808 3,856 4,417 Total depreciation and amortization included in cost of revenues 8,947 9,164 8,950 7,299 6,467 Non-GAAP gross profit： Central laboratory channel54,521 44,037 44,300 38,921 39,650 In-hospital channel35,990 38,210 15,638 40,716 44,882 Pharma research and development channel18,858 12,837 27,125 13,356 17,373 Total non-GAAP gross profit109,369 95,084 87,063 92,993 101,905 Non-GAAP gross margin： Central laboratory channel82.3% 82.3% 86.4% 81.7% 81.3% In-hospital channel66.9% 70.1% 54.3% 70.9% 75.0% Pharma research and development channel72.0% 65.5% 66.2% 64.8% 64.6% Total non-GAAP gross margin74.8% 74.5% 71.9% 74.0% 75.2%

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	17 Mar 2020

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR exon 19 Deletions Mutant Non-small Cell Lung Cancer	NDA/BLA	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	19 Jul 2024
EGFR exon 21 Substitution Mutant Non-small Cell Lung Cancer	NDA/BLA	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	19 Jul 2024
Non-Small Cell Lung Cancer	NDA/BLA	EU	EQRx International, Inc.	02 Dec 2022
metastatic non-small cell lung cancer	Phase 3	US	EQRx International, Inc.	14 Dec 2022
Residual Neoplasm	Phase 3	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	20 Jun 2022
Non-small cell lung cancer stage IIIB	Phase 3	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	30 Apr 2021
EGFR positive non-small cell lung cancer	Phase 3	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	18 Mar 2021
EGFR-mutated non-small Cell Lung Cancer	Phase 3	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	14 Sep 2020
Locally Advanced Lung Non-Small Cell Carcinoma	Phase 3	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	26 Nov 2018
Non-small cell lung cancer stage I	Phase 2	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	14 Jan 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04354961 (ARISE, ESMO_ASIA2024) Manual	Phase 2	Adenosquamous Carcinoma EGFR Mutation	12	Aumolertinib 110 mg	ryhgvxfdxx(ktfbhmxzde) = csojtlwiuo zktnlhdyfu (zpajpmlxof ) View more	Positive	07 Dec 2024
NCT04354961 (ARISE, ESMO_ASIA2024) Manual	Phase 2	Adenosquamous Carcinoma EGFR Mutation	12	Aumolertinib 110 mg (Exon 19 deletion)	ryhgvxfdxx(ktfbhmxzde) = vczmimsxcj zktnlhdyfu (zpajpmlxof ) View more	Positive	07 Dec 2024
ALWAYS (ESMO_ASIA2024) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line	26	Aumolertinib plus Anlotinib	lwqqroxsyz(jwyjjbfyum) = gduahzmgjp xhnkhmiuqw (nhrpxsbfdg, 80.4 - 99.9) View more	Positive	07 Dec 2024
ALWAYS (ESMO_ASIA2024) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer First line	26	Aumolertinib plus Anlotinib (Intracranial)	lwqqroxsyz(jwyjjbfyum) = kpjtcegklr xhnkhmiuqw (nhrpxsbfdg, 50.1 - 93.2) View more	Positive	07 Dec 2024
ESMO_ASIA2024 Manual	Not Applicable	Adenocarcinoma of Lung Second line EGFR Mutation	1	High-dose Aumolertinib plus Anlotinib	cyovxygjdv(iqlfxqivqu) = hqvwhkrzsc bnutvtvkto (wocycojwlv )	Positive	07 Dec 2024
ESMO_ASIA2024 \| NEWS Manual	Not Applicable	Lung Cancer \| Breast Cancer EGFR T790M \| EGFR L858R	1	aumolertinib	uqjguleifv(eqwjhdnfst) = The patient's response assessment was evaluated as partial response. urrbknbxee (vvhyfmmjbk ) View more	Positive	06 Dec 2024
NCT04923906 (AENEAS2, NEWS) Manual	Phase 3	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	-	甲磺酸阿美替尼片联合化疗	bzttrzkosd(bbzhagewsh) = 超过2年 lsffglxrjd (hammkuetud ) Met View more	Positive	22 Oct 2024
WCLC2024 Manual	Not Applicable	EGFR-mutated non-small Cell Lung Cancer Adjuvant EGFR positive mutation (19Del or L858R)	113	Aumolertinib 110 mg	qgjoguazab(cijptrxabf) = 24 pts (21.2%) had TRAEs of any grade, such as mild rash and diarrhea. No grade≥3 adverse events occurred. No pts withdrew from therapy due to adverse drug reactions. imxzwcncqz (vmcunfgdra )	Positive	10 Sep 2024
NCT04778800 (WCLC2024) Manual	Not Applicable	EGFR positive non-small cell lung cancer First line EGFR Mutation	26	Aumolertinib 110mg	kihnobtmsl(cnydrxgzqp) = hkjeldscwg iscxnbbmmz (cbkywryuuq, 88.8 - 100) View more	Positive	08 Sep 2024
NCT04778800 (WCLC2024) Manual	Not Applicable		26	Aumolertinib 165mg	kihnobtmsl(lfutdkloli) = brvzafyotk adejjdqjpg (nzasgurnrl ) View more	Positive	08 Sep 2024
WCLC2024 Manual	Not Applicable	EGFR positive non-small cell lung cancer EGFR Mutation	5	Aumolertinib 165mg	(pxonzojfrg) = xcsizllasj azgzxftwog (otmifmskxx ) View more	Positive	07 Sep 2024
ChiCTR2200066768 (WCLC2024) Manual	Phase 2	EGFR-mutated non-small Cell Lung Cancer Adjuvant EGFR positive mutation (19Del or L858R)	31	Aumolertinib 110 mg	giroskdrvg(xqhnnctppj) = cpfcwbnbcp ocvyxxsdql (iapuewlust ) View more	Positive	07 Sep 2024
WCLC2024 Manual	Not Applicable	EGFR-mutated non-small Cell Lung Cancer First line EGFR Mutation	16	Aumolertinib 110mg	fogalptbkp(sxygkktvvq) = naxdbmxptf pnokacbomk (cynlofprux ) View more	Positive	07 Sep 2024
WCLC2024 Manual	Not Applicable		16	Aumolertinibradiotherapy (WBRT)	fogalptbkp(sxygkktvvq) = ocrkhcjytz pnokacbomk (cynlofprux ) View more	Positive	07 Sep 2024

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