According to statistics from the Insight database, this week (August 18 - August 24), a total of 82 innovative drugs (including improved new drugs) worldwide have advanced to new stages of development, among which 1...One approved for marketing, one submitted for marketing approval, six entered Phase III clinical trials, 129 products approved for clinical trials, 9 products submitted for clinical trials.The following text will introduce some key projects from both within and outside China.Progress of Innovative Drugs OverseasOverseas, a total of 30 innovative drugs (including improved new drugs) have advanced to new stages in their development this week. Among them, one has initiated Phase III clinical trials, 14 have started clinical trials for the first time, and three have been approved for clinical trials. In addition, there are more highlights in the expansion of new indications, pharmaceutical transactions, and clinical results.1. Johnson & Johnson: Bispecific Antibody + EGFR-TKI Therapy Approved for First-Line NSCLC! Head-to-Head "Challenge" Against OsimertinibOn August 20, Johnson & Johnson announced that the FDA had approved its EGFR/c-Met bispecific antibody.Amivantamab（Amivantamab，RYBREVANT®）With EGFR InhibitorsLazertinib（LAZCLUZE™）The combined treatment regimen,For first-line treatment of adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or exon 21 L858R substitution mutations.This combination, which previously gained widespread attention for its head-to-head "sniping" of AstraZeneca's blockbuster drug osimertinib, has now also successfully entered the EGFRm NSCLC market worth tens of billions.Screenshot source: Johnson & Johnson official websiteThe approval of Johnson & Johnson's combination therapy was based on the results of the pivotal Phase III clinical trial, the MARIPOSA study. The studyAimed to evaluateAmivantamab Efficacy and Safety of Lazertinib in Combination with Third-Generation EGFR TKI Osimertinib versus Lazertinib Monotherapy as First-Line Treatment for EGFR-Positive Advanced NSCLC. The clinical results were initially presented at the 2023 ESMO and published in the NEJM, with updated data later presented at the 2024 ASCO and 2024 WCLC.The results showed,Compared with Osimertinib,The combination regimen reduced the risk of disease progression or death by 30%, with a median PFS of 23.7 months compared to 16.6 months for osimertinib; DOR was also extended by 9 months, being 25.8 months vs 16.7 months.2. Eisai: Lecanemab Scores Another Approval, Launched in the UKOn August 23, Eisai and Biogen announced that the Aβ monoclonal antibody "Lecanemab" has been approved by the UK MHRA for the treatment of AD-related mild cognitive impairment and mild AD patients, applicable to apolipoprotein E ε4 carriers.（ApoE ε4）Adult patients who are heterozygous or non-carriers.The press release noted that lecanemab is the first treatment approved by European countries for early Alzheimer's disease (Mild cognitive impairment or mild dementia caused by Alzheimer's diseaseTreatment Methods for Potential Causes.This approval is mainly based on Eisai's Phase 3 clinical research data from CLARITY AD. This was a global, randomized, double-blind, parallel-group, placebo-controlled study, in which lecanemab achieved the primary endpoint.(Change in Clinical Dementia Rating Scale Sum of Boxes [CDR-SB] from baseline at 18 months)And all key secondary endpoints, with results of significant statistical significance. In the applicable population in the UK, the most common adverse reactions are infusion-related reactions and amyloid-related imaging abnormalities with hemorrhage.(Microbleeds) (ARIA-H), falls, headache, and amyloid-related imaging abnormalities with cerebral edema（ARIA-E）。The global development and registration application of Lecanemab are led by Eisai, while the product is co-commercialized and promoted by Eisai and Biogen. Among them, Eisai has the final decision-making power. In the UK, Eisai and Biogen will jointly be responsible for the commercial promotion of the product, and Eisai will distribute the product as the marketing authorization holder.1. Bristol-Myers Squibb: O+Y Combination Therapy Submits for First-Line HCC Indication in the United States
On August 21, Bristol-Myers Squibb announced that the U.S. FDA has accepted its supplemental Biologics License Application (sBLA) for the first-line treatment of unresectable hepatocellular carcinoma (HCC) using the combination of blockbuster PD-1 nivolumab (Opdivo) and CTLA-4 antibody ipilimumab (Yervoy). The PDUFA date is April 21, 2025.Screenshot from: BMS official websiteThis application is primarily based on the results of the Phase III clinical trial CheckMate-9DW. The study evaluated the efficacy and safety of the O+Y combination therapy compared to investigator's choice of sorafenib or lenvatinib in previously untreated patients with advanced HCC, enrolling a total of 668 patients, with OS as the primary endpoint.The results showed that, with a median follow-up of approximately 35.2 months, the combination therapy provided a clinically meaningful and statistically significant improvement in OS, with a median OS of 23.7 months (95% CI: 18.8–29.4) compared to 20.6 months (95% CI: 17.5–22.5) in the control group, HR 0.79 (0.65-0.96, p=0.018).According to the Insight database, before the FDA submission, BMS had already filed for the first-line hepatocellular carcinoma indication in Japan, Europe, and China.Screenshot source: Insight Database Web Version2. Daiichi Sankyo/AstraZeneca: Enhertu Submits New Indication in the EU, Expanding to HER2 Ultra-Low Expression Breast Cancer
On August 19, Daiichi Sankyo announced that the European Medicines Agency (EMA) has accepted the new indication application for Enhertu (trastuzumab deruxtecan), the blockbuster ADC developed in collaboration with AstraZeneca. It is intended as a monotherapy for adult patients with unresectable or metastatic HER2-low (IHC 1+ or 2+/ISH-) or HER2-ultralow (IHC >0 <1+) breast cancer who have received at least one prior endocrine therapy.This means that after Enhertu successfully targeted HER2-low breast cancer, it has once again extended its reach in the breast cancer field to include HER2-ultra-low expression.On the same day, the U.S. FDA also granted Breakthrough Therapy Designation based on this indication.Screenshot from: Daiichi Sankyo's official websiteThis application is based on Phase III clinical trials. The positive results of DESTINY-Breast06 (hereinafter referred to as DB06) were showcased as an LBA oral presentation at the 2024 ASCO.The results showed that in the ITT population, the mPFS was 13.2 months (95% CI, 12.0-15.2) in the trastuzumab deruxtecan group (n=436) and 8.1 months (95% CI, 7.0-9.0) in the chemotherapy control group (n=430); the 12-month OS rates were 87.0% vs 81.1% (HR=0.81 [95% CI, 0.65-1.00]), respectively. Specifically, in subgroups with different HER2 expression statuses, the data trends were generally consistent.1. Lilly: Long-term health benefits! Tirzepatide reduces the risk of developing type 2 diabetes by 94%
On August 20, Eli Lilly announced positive results from the 3-year SURMOUNT-1 study (176-week treatment period), which evaluated the efficacy and safety of once-weekly tirzepatide for long-term weight management and delaying diabetes progression in obese or overweight adult patients with prediabetes.Compared with placebo, weekly injection of Tirzepatide (5 mg, 10 mg, 15 mg) significantly reduced the risk of developing type 2 diabetes by 94% in obese or overweight adults with prediabetes.Moreover, the use of Tirzepatide Injection can continuously reduce patient weight during the treatment period. At the end of the treatment, the average weight loss for adults using 15 mg of Tirzepatide was 22.9%, while the average weight loss for obese or overweight adults in the prediabetes stage using a placebo was 2.1%.SURMOUNT-1 (NCT04184622) is a multicenter, randomized, double-blind, parallel, placebo-controlled study. The study enrolled overweight or obese adult patients without type 2 diabetes who have at least one comorbidity (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease). It aims to compare the weight loss efficacy and safety of tirzepatide (5 mg, 10 mg, 15 mg) in combination with diet control and increased exercise versus placebo.The 1,032 participants who were prediabetic at the start of the study will continue to participate in an additional 104 weeks of treatment in the SURMOUNT-1 trial after the initial 72-week trial is completed, to evaluate the impact on body weight and the potential differences in progression to type 2 diabetes after three years of treatment with tirzepatide compared to placebo.This study demonstrates that tirzepatide can reduce the risk of progressing to type 2 diabetes in obese or overweight adults with prediabetes and help maintain long-term weight loss. Detailed results will be submitted by Eli Lilly to a peer-reviewed journal and presented at ObesityWeek 2024, held from November 3 to 6, 2024. Pharmaceutical TransactionsThis week, according to the Insight database, there were 20 pharmaceutical transactions globally, among which two overseas licensing deals for ADCs produced in China are noteworthy for readers in China.1. Kelun Biotech, Merck: Terminate SKB315 Collaboration, New Authorization for SKB571
On August 20, Kelun Pharmaceuticals announced the latest development in its collaboration with Merck: Merck returned the collaboration rights for the CLDN18.2 ADC project SKB315, while exercising its option to obtain overseas rights (i.e., rights excluding mainland China and Hong Kong/Macau regions) for the bispecific ADC project SKB571.Specifically, in terms of transaction terms, Kelun is not required to refund the previously received upfront payment for the SKB315 project, while the SKB571 project has newly obtained 37.5 million US dollars. Further milestone payments and tiered royalties based on net sales will be obtained after reaching specific development and sales milestones.Kelon expressed strong confidence in the SKB315 project, stating that it will deeply develop the drug based on China's vast gastric cancer market and explore overseas markets through appropriate means.The changes in this transaction between the two parties, solely from the perspective of the transaction projects, on the one hand reflect the extremely fierce competition surrounding the CLDN18.2 target, and on the other hand demonstrate that bispecific ADCs are gradually standing out in the ADC field, becoming a new drug type that companies are vying to explore.From the corporate perspective, it highlights Merck's extreme focus on the ADC field. Throughout the drug development process, Merck flexibly strategizes its ADC assets by considering elements such as the drug’s own data and the constantly evolving competitive market landscape. Meanwhile, Kelun leverages its deep and extensive ADC platform and technical expertise to adapt to the changing external environment, continuously leading in the ADC sector and serving as a top-tier collaborator for multinational corporations (MNCs).2. Puzhong Discovery, Adcendo: TF ADC Collaboration Achieved
August 20On [date], Puzhong Discovery and Adcendo jointly announced that the two parties have reached an agreement on a novel, highly differentiated tissue factor-targeted [product].（Anti-TF）Antibody-drug conjugate (ADC) ADCE-T02(Puzhong Discovery R&D Code AMT-754)Under the licensing agreement, Adcendo will obtain global exclusive development and commercialization rights outside of Greater China, while Puzhong Discovery will retain rights in the Greater China region.(Including mainland China, Hong Kong, Macao and Taiwan regions)The development and commercialization rights.According to the financial terms of the agreement, PuZhong Discovery will receive an upfront payment of several tens of millions of dollars. Upon achieving subsequent development, regulatory, and commercial milestones, it will be entitled to receive total milestone payments exceeding 1 billion US dollars, as well as sales royalties in the low single-digit to low double-digit percentage range based on global net sales (excluding Greater China).Tissue factor (TF) is overexpressed in bladder cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, esophageal cancer, head and neck cancer, and gastrointestinal cancer, but its expression is restricted in normal tissues, making it one of the highly promising ADC targets. ADCE-T02 is a novel, differentiated TF-targeting ADC that utilizes the T1000-exatecan linker-payload platform. Its unique antibody design mitigates the impact on the coagulation pathway, while this platform has been shown to amplify the "bystander effect," enhance linker stability, and possess the potential to overcome drug resistance mechanisms. Qualification Certification1. Hansoh Pharma, GSK: B7-H3 ADC Collaboration Receives FDA Breakthrough Therapy DesignationOn August 20, HANSON Pharma announced that its partner, GlaxoSmithKline (GSK), received Breakthrough Therapy Designation from the U.S. FDA for HS-20093 (GSK5764227). This B7-H3 targeted antibody-drug conjugate (ADC) is being evaluated for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) who have progressed during or after platinum-based chemotherapy (recurrent or refractory).
The FDA’s Breakthrough Therapy designation was supported by data from Hansoh Pharma’s ongoing ARTEMIS-001 Phase I open-label, multicenter trial. The trial, which involved more than 200 patients, evaluated the safety, tolerability, and preliminary anti-tumor activity of HS-20093 in locally advanced or metastatic solid tumors, including relapsed or refractory ES-SCLC. The results will be presented at the 2024 World Conference on Lung Cancer (WCLC) held in San Diego, California, USA, from September 7 to 10, 2024.
On December 20, 2023, Hansoh Pharma entered into an exclusive licensing agreement with GSK, granting GSK a worldwide exclusive license (excluding mainland China, Hong Kong, Macao, and Taiwan) to develop, manufacture, and commercialize HS-20093.
Progress of Innovative Drugs in ChinaThis week, a total of 48 innovative drugs (including improved new drugs) in China have advanced to new stages of development, including 2 approved for marketing, 1 submitted for marketing approval, 3 initiating Phase III clinical trials, 14 new drugs approved for clinical trials, and 7 submitted for clinical trial applications.
Six Innovative Drugs (Including Modified New Ones) Approved for Clinical Trials in China for the First Time This WeekSource: Insight Database Web Version(The following text is from the same source unless otherwise specified.)1. Innovent/GHF: The First in China! KRAS G12C Inhibitor Approved for MarketingOn August 21, the NMPA official website announced that Innovent Biologics had submitted "Fluzelase」Approved for Marketing(Product name: Da Bo Te), for the treatment of advanced non-small cell lung cancer with KRAS G12C mutation who have received at least one systemic therapy.This is not only the first approved KRAS G12C inhibitor in China, but also the world's first domestically produced drug targeting the same point, marking a milestone.
Screenshot source: NMPA official websiteFluzelase（IBI351）It is a KRAS G12C inhibitor, initially developed by GenFleet Therapeutics.In September 2021, Innovent Biologics and GenFleet Therapeutics reached a licensing collaboration, obtaining the rights to the drug in China.（Including mainland China, Hong Kong, Macao and Taiwan）The development and commercialization rights, and has the option for global development and commercialization rights.This transaction is worth up to $312 million.On November 24, 2023, the CDE accepted the new drug marketing application for Fuzelase and included it in the priority review.The approval process took only 9 months this time, which is incredibly fast.Fuzelrezumab Receives Conditional Approval Based on a Phase II Single-Arm Registration Study Conducted in China, Trial registration number: NCT05005234.Clinical results show that the Independent Imaging Review Committee（IRRC）Confirmed Objective Response Rate（ORR）Reached 49.1%, achieving the pre-set primary endpoint; disease control rate（DCR）Up to 90.5%; median duration of response（DoR）The median progression-free survival was 8.3 months.（mPFS）The median survival period was 9.7 months.（OS）Not yet reached.According to the Insight database, there are currently 2 other Chinese-produced new drugs targeting the same point that have applied for marketing in China.: Zhengda Tianqing/Yifang Biotech's "Geshurexi"、JACOB's "Gore Release"Insight expects the two applications to be approved for marketing in 2024Q4 and 2025Q2, respectively.2. Astellas/Pfizer: "Vientoyumab" Approved for Marketing, the First in ChinaNectin-4 ADCOn August 19, the NMPA official website announced that Astellas' Nectin-4 ADC "Vientamab"Approved for Marketing"（JXSS2300022/3）, for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have previously received PD-1/PD-L1 inhibitors and platinum-based chemotherapy.Thus, Vedotin Becomes the First Nectin-4 Targeted ADC Approved in China.Screenshot source: NMPA official websiteVedotin is jointly developed by Astellas and Seagen, a subsidiary of Pfizer., the marketing application of this drug in China is based on a single-arm, open-label, multi-center study conducted in China.Phase II Bridging Clinical Trial EV-203（NCT04995419）Data.EV-203 Study Aims to Evaluate the Efficacy and Safety of Vinblastine Monoclonal Antibody in Chinese Patients with Locally Advanced or Metastatic Urothelial Carcinoma Previously Treated with PD-1/PD-L1 Inhibitors and Platinum-based Chemotherapy, Enrolling 40 Chinese Patients with the Primary Endpoint Being the Independent Review Committee.（IR）Confirmed Objective Response Rate (ORR）。At the 2023 ASCO Annual Meeting, researchers presented the trial results of EV-203. The data showed:IRC-Confirmed ORR was 37.5%, 1 patient（2.5%）Achieved PR, 14 patients（35.0%）Achieved PR. The DCR assessed by IRC was 72.5%.Median DOR not reached; Median PFS was 4.67 months,Median OS not reached.Notably, Astellas has submitted the second indication application for Vinblastine in China in March 2024: in combination with PD-1 antibody Pembrolizumab for first-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have not been previously treated. The Insight database predicts that this application is expected to be approved in the third quarter of 2025.1. Kelun Biotech: TROP2 ADC Submits for Second IndicationOn August 20, the CDE official website showed that Kelun-Biotech's TROP2 ADC "Lukansatuzumab"、i.e., SKB264 New Indication Marketing Application Accepted(Application No.: CXSS2400087), for patients with locally advanced or metastatic EGFR-mutated NSCLC who have failed EGFR-TKI and platinum-based chemotherapy, this is the second indication for the drug. Previously, on August 14, the application had been granted priority review by the CDE.Screenshot source: CDE official websiteThe acceptance of this marketing application is based on a multicenter, randomized, pivotal clinical study, OptiTROP-Lung03,The study evaluated trastuzumab deruxtecan weekly（Q2W）5 mg/kg Intravenous Injection vs. Docetaxel in Patients Treated with EGFR-TKIResults in patients with locally advanced or metastatic EGFR-mutant NSCLC who failed platinum-based chemotherapy. In a pre-specified analysis, compared with docetaxel, amivantamab (sac-TMT) In the objective remission rate(ORR)and Progression-Free Survival(PFS) Significant improvements with both statistical and clinical significance.The first marketing application for Lucantusumab was submitted inAccepted by the CDE on December 8, 2023,For locally advanced or metastatic triple-negative breast cancer that has received at least two prior systemic treatments (at least one of which was for advanced or metastatic stage). The Insight database predicts that this application is expected to be approved in the fourth quarter of this year.2. Hansoh Pharma: Third-Generation EGFR-TKI Submits for Fourth IndicationOn August 20, the CDE website showed that Hansoh Pharma's "Almonertinib" new indication marketing application was accepted.(Application No.: CXHS2400077), for the treatment of unresectable locally advanced NSCLC with EGFR exon 19 deletion or exon 21 (L858R) substitution mutations without disease progression after platinum-based radical chemoradiotherapy. Meanwhile, this application has also been accepted by the CDE.Proposed for Priority Review。This is the 4th indication marketing application for Aumetinib.Insight database predicts that the application is expected to be approved in the second quarter of 2025.
Screenshot source: CDE official websiteAmeitinib is a third-generation EGFR-TKI developed by Hansoh Pharma. It has previously been approved for two indications in China: 1) Used for...Second-line TreatmentPatients with locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI treatment and are T790M mutation-positive; 2)First-line TreatmentAdult patients with locally advanced or metastatic NSCLC who are positive for EGFR exon 19 deletion or exon 21 (L858R) substitution mutations.On July 19 this year,CDE Also Accepted the Third Indication Application for Ameitinib, used for EGFR exon 19 deletion or exon 21 (L858R) Positive NSCLC adult patients with tumor resection as adjuvant treatment. Insight database predicts that this application is also expected to be approved in the second quarter of 2025.The fourth indication for marketing authorization of Almonertinib to be included in the CDE’s priority review this time is based on clinical trial data from the HS-10296-304 study, a randomized, controlled, double-blind Phase III clinical trial.（CTR20210297），Currently, Hansoh Pharma has not disclosed the specific clinical trial data of this study.3. InnoCare Pharma: BTK Inhibitor Submits New IndicationOn August 21, the CDE website showed that InnoCare Pharma's "Orelabrutinib"New Indication Marketing Application Accepted"(Application No.: CXHS2400078), which will become the 4th indication for Orelabrutinib. Insight database speculates that the new indication applied for this time may be: first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).Screenshot source: CDE official websiteOrelabrutinib's layout is not limited to the oncology field but is also advancing simultaneously in the immunology field.In April 2024, Orelabrutinib TreatmentPrimary Immune Thrombocytopenia (ITP)The phase II research results have been published in the American Journal of Hematology, and more than half of the patient enrollment for the phase III registration clinical trial has been completed.TreatmentSystemic Lupus Erythematosus (SLE)The Phase IIa clinical trial has also achieved positive results, showing a dose-dependent improvement trend in the SLE Responder Index-4 (SRI-4), while a decreasing trend in proteinuria was observed. Orelabrutinib is the world's first BTK inhibitor to demonstrate efficacy in a Phase II clinical trial for SLE. The Phase IIb trial is currently ongoing, with patient enrollment nearing completion as of the reporting period.4. Bangsun Pharmaceutical: JAK2 Inhibitor Submission for Market ApprovalOn August 22, the CDE website showed that Bangshun Pharmaceutical had developed a Class 1 new drug, a JAK2 inhibitor named Bangruiti.Ni (OB756)Marketing application accepted by CDE, for the treatment of intermediate- and high-risk myelofibrosis patients. This is also the first core pipeline for which Bangshun Pharmaceutical has submitted an NDA. According to the Insight database, Bangruitinib is also the first domestically developed selective JAK2 single-target inhibitor submitted for marketing approval in China.
Screenshot source: CDE official websiteThis marketing application is based on a Phase Ⅱ/Ⅲ clinical study, BEWELL-301, conducted in Chinese patients with myelofibrosis.(CTR20211396) The positive results. The study successfully reached its primary endpoint in December 2023.The study shows that: in terms of the effective rate of spleen contraction, constitutional symptoms of the subjects, and the quality of life of the subjects,Baricitinib GroupThe improvement in patients was significantly better than that in the control group; during the study treatment, baricitinib demonstrated good overall safety and tolerability.In addition, Bangsun Pharmaceutical is conducting a Phase III clinical trial of Banguretinib for polycythemia vera and a Phase II clinical trial for essential thrombocythemia.1. JACOBIO: SHP2 Inhibitor Project Development TerminatedOn August 21, JACOBIO announced that the board of directors had resolved to terminate the development of the SHP2 inhibitor project JAB-3068.Source: JACOBIO AnnouncementJACOB previously reached a collaboration with AbbVie in June 2020 to authorize the development of this SHP2 inhibitor. However, in July 2023, the two parties terminated the collaboration, and global rights reverted to JACOB. At the time of the project termination, JAB-3068 was in Phase I/II clinical trials.This week marks the intensive release period of mid-year financial reports for pharmaceutical companies in China, with notable performance highlights from companies such as Hengrui, Shiyao, Ascentage, and InnoCare. Insight provides a brief summary and sharing:On the evening of August 21, Hengrui Medicine released its 2024 semi-annual report. The report shows,Hengrui's revenue reached 13.601 billion yuan, representing a year-on-year increase of 21.78%.. Among them,Revenue from innovative drug sales reached 6.612 billion yuan, representing a year-on-year increase of 33.25%.。R&D investment reached 3.86 billion yuan, a year-on-year increase of 26.23%.In terms of R&D progress, during the reporting period, Hengrui had 2 innovative drug NDAs accepted, and 10 research projects entered Phase III clinical trials., 20 projects in Phase II clinical trials, 19 projects in Phase I clinical trials.On August 21, CSPC Pharmaceutical Group released its financial report for the first half of 2024.In the first half of the year, CSPC Pharmaceutical Group's revenue was 16.284 billion yuan(+1.3%); among which,Revenue from the pharmaceutical business was 13.549 billion yuan（+4.8%）。In terms of R&D investment, Shijiazhuang Pharmaceutical Group's R&D expenses in the first half of the year amounted to 2.542 billion yuan, representing a year-on-year increase of 10.3%. Currently, the company has approximately 60 key drugs under development that have entered clinical or submission stages, including 7 for which market approval applications have been submitted and 19 in pivotal registration trials.On August 22, Ascentage Pharma announced its 2024 interim results. During the reporting period, Ascentage Pharma achieved record-high revenue.Achieved revenue of RMB 8.24 billion, representing a year-on-year increase of 477% compared to last year., mainly derived from product sales revenue and income from external cooperation and licensing, etc. The first marketed productOrelabrutinib (Product Name: Naliq) Achieved sales revenue of RMB 1.13 billion. It is worth mentioning that,This is the first time that Ascentage Pharma has turned a profit., with a net profit of RMB 163 million.On August 20, InnoCare Pharma announced its interim results for 2024.In the first half of 2024, InnoCare Pharma achieved total revenue of 420 million yuan, primarily driven by the sales of Orelabrutinib.Entering 2024, the new national medical insurance catalog has been implemented, and all three indications for Orelabrutinib have been covered by medical insurance. The product's sales in Q2 of 2024 were 253 million yuan, compared to 170 million yuan in the same period last year, representing a year-on-year increase of 49%. The sales in the first half of 2024 were 418 million yuan, compared to 321 million yuan in the same period last year, representing a year-on-year increase of 30%.Source:Official News/Information Released by Pharmaceutical Companies, Insight DatabaseCover Source:ZCOOL Hello Plus
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