2025 ASCO Abstracts Released; Domestic Bispecific Antibody Secures $6B+ Out-Licensing Deal; Seven New Drug Indications Approved in China | Insight Weekly Drug Report

According to statistics from the Insight database, this week (May 18 - May 24), a total of 67 innovative drugs (including improved new drugs) worldwide have advanced to new stages of development, with 4 being approved for marketing and 3...Application for marketing approval, 19 products have entered clinical trials, 1216 products have been approved for clinical trials, and 16 products have applied for clinical trials.

Below, Insight will introduce the progress of some key projects at home and abroad this week.

Local time on May 22, GSK（GSK）Announced that the US FDA has approved its IL-5 monoclonal antibodyMepolizumab（Nucala）New Indication Approval, used forAdjunctive Maintenance Treatment for Eosinophilic COPD Patients。

This is the firstApproved for the treatment of COPDIL-5 monoclonal antibody, alsoThe world's first approved biologic that can be administered once a month to treat COPD patients, representing a breakthrough in COPD treatment.

Screenshot source: Corporate official website

Mepolizumab, a key product of GSK, is also the world's first approved IL-5 monoclonal antibody. The drug has previously been approved in the United States, the European Union, Japan, China, and other countries and regions for the treatment of four IL-5-mediated diseases, including eosinophilic asthma, allergic granulomatous vasculitis, hypereosinophilic syndrome, and chronic rhinosinusitis with nasal polyps.

Since its initial approval in November 2015, its sales have been increasing year by year. In 2024, the drug's sales reached $2.279 billion, a year-on-year increase of 10%.

This approval means that Mepolizumab has becomeThe First IL-5 Monoclonal Antibody Approved for the Treatment of COPD、The World's First Biologic Treatment for COPD Administered Once Monthly, and at the same time isThe World's 2nd COPD Biologic Drug。

For the COPD indication, GSK has successively conducted three Phase III clinical trials of mepolizumab for the treatment of COPD. The third Phase III clinical trial is MATINEE.（NCT04133909）DurationMore than five years, ultimately reaching the primary endpoint, supported the approval of mepolizumab for the COPD indication.

MATINEE is a randomized, double-blind, parallel, placebo-controlled Phase III trial designed to compare mepolizumab 100 mg as an add-on therapy.(Once every 4 weeks by subcutaneous injection, for a total of 52-104 weeks)Triple Therapy with Placebo Inhalation(Dual-acting long-acting bronchodilator + inhaled corticosteroid)Efficacy and safety. The study included 804 COPD patients with a history of disease exacerbation and evidence of type 2 inflammation characterized by elevated blood eosinophil count.

The study concludedFruit Already In"The New England Journal of Medicine" (NEJM)Published.Data show:

• Compared with the placebo group,MepolizumabGroupThe annualized rate of moderate/severe exacerbations was reduced by 21% in patients.，With clinicalClinically and statistically significant, reaching the primary endpoint of the study。

• In a post-hoc analysis of patients clinically assessed as having chronic bronchitis, compared with the placebo group,The annualized rate of moderate/severe exacerbations in the Mepolizumab group was reduced by 31%.。

• Reducing hospital admissions is a key goal in COPD management. In the study, mepolizumabReduced the annualized rate of disease episodes leading to emergency room visits and/or hospitalizations by 35%.。GSK pointed out that mepolizumab is the only biologic agent with Phase III clinical trial data showing a reduction in emergency department visits and/or hospitalizations.

• Patient-Reported Outcomes in the Mepolizumab Group (PRO)The remission rate was higher, but in the St. George's Respiratory Questionnaire（SGRQ）COPE Assessment Test（CAT）In terms of quality of life scores, there was no significant difference between the mepolizumab group and the placebo group.

• The incidence of adverse events was similar for mepolizumab and placebo, with the most common being COPD exacerbation or worsening and COVID-19 infection.

On May 19 local time, GSK announced, Blenrep（belantamab mafodotin）Approved by Japan PMDA for Relapsed or Refractory Multiple Myeloma（R/R MM）。

This is BlenrepFollowing the approval in the UK, this is the second global approval received. Currently, the drug has already been approved in includingChina, the United States, EuropeSubmit marketing applications in multiple countries and regions, including within, and are expected to welcome more approvals in 2025. It is also worth mentioning that on May 23, GSK announced that this therapy has received a positive opinion from the EU CHMP, indicating that it will soon be approved for marketing in the EU region.

Belantamab mafodotin（Maveralimab）YesAn ADC targeting BCMA. The drug's development and path to market have faced numerous setbacks, initially in 2In August 2020, based on the results of the pivotal Phase II clinical DREAMM-2 study, it was successively approved for marketing by the U.S. FDA and the EU EMA asMonotherapy for the Treatment of Relapsed/Refractory Multiple Myeloma in Adult Patients，Has becomeThe World's First Approved BCMA ADC。

However, in November 2022, GSK announcedDREAMM-3 Study Did Not Meet Its Primary Endpoint of Progression-Free Survival (PFS)EndpointBased on this, GSK voluntarily withdrew the Belantamab mafodotin marketing application in the United States. Subsequently, the EU EMA also withdrew the marketing authorization for Belantamab mafodotin.

After a series of setbacks, GSK did not abandon this project but continued to explore the drug in clinical trials, eventually succeeding in the DREAMM-7 study.

The researchers evaluatedBelantamab mafodotin + Bortezomib + DexamethasoneAndDaratumumab +Bortezomib + DexamethasoneEfficacy and Safety of Combination Therapy in Patients with Relapsed/Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy, with PFS as the Primary Endpoint.

Data presented at the 2024 ASCO Annual Meeting showed that, in the intent-to-treat population (ITT):

• In terms of median PFS,Belantamab mafodotin Group: 36.6 months, significantly higher than the 13.4 months in the daratumumab group;

• Compared with the standard treatment of daratumumab combination,Reduced the risk of disease progression or death by 59% in patients；

• ORR,Belantamab mafodotin Group: 82.7%(vs daratumumab group 71.3%);

• Belantamab mafodotin The group treatment showed a strong, clinically meaningful trend in terms of overall survival rate.The risk of death was reduced by 43%.

In addition, in the Phase III clinical trial DREAMM-8, researchers further evaluatedBelantamab mafodotin + Pomalidomide + DexamethasoneCombination Therapy withBortezomib + Pomalidomide + DexamethasoneEfficacy and Safety of Combination Therapy in Relapsed/Refractory MM Patients Who Have Previously Received at Least One Line of Treatment

Compared with the patient population studied in the DREAMM-7 trial, patients in DREAMM-8 received more prior treatments., because all patients had previously received lenalidomide treatment, 75% of patients were resistant to lenalidomide, and 25% of patients had previously receivedDaratumumabTreatment, most of which are forDaratumumabDrug-resistant.

DREAMM-8 Study Shows that in R/R MM, the Belantamab Mafodotin Group Demonstrates a Statistically and Clinically Significant PFS Advantage, as well as Deeper and More Durable Responses, Showing a Favorable OS Trend with Manageable Safety.

Based on these two studies, GSK submitted to regulatory agencies worldwideBlenrep's Marketing Application: 2025 Set to Be the "Year of Rebirth" for This Blockbuster New Drug.

3SBio Reports in Poster FormatPD1/VEGF Bispecific Antibody SSGJ-7Phase II Clinical Trial of Single-Agent Therapy for Advanced NSCLC Patients（SSGJ-707-NSCLC-II-01，NCT06361927）Data.

Source: ASCO Official Website

This is a single-arm, open-label Phase II clinical study designed toEvaluate the effectiveness of different dosing regimens of SSGJ-707 in subjects with advanced NSCLC. As of January 10, 2025, there have been83 cases of NSCLC patientsPatients received SSGJ-707 treatment at doses of 5mg/kg Q3W (n=31), 10mg/kg Q3W (n=34), 20mg/kg Q3W (n=12), and 30mg/kg Q3W (n=6).

The median age of the patients was 64 years, 83.1% of the patients had an ECOG PS score of 1, 44.6% of the patients had squamous cell carcinoma, 66.3% of the patients had PD-L1 expression levels of 1%-49%, and 33.7% of the patients had PD-L1 expression levels ≥50%.

Among the 76 patients who completed at least one efficacy assessment, the ORR and DCR were 29.6% at dose levels of 5 mg/kg Q3W, 10 mg/kg Q3W, 20 mg/kg Q3W, and 30 mg/kg Q3W, respectively. (8/27)、85.2% (23/27)；61.8% (21/34)、97.1% (33/34)；54.5% (6/11) 、90.9% (10/11) ； 25% (1/4)、75% (3/4)。

SSGJ-707 10 mg/kg Q3W Demonstrates Promising Efficacy in Previously Untreated Advanced Non-Small Cell Lung Cancer. At this dose, the ORR for non-squamous cell carcinoma and squamous cell carcinoma patients were 54.5%, respectively.(12/22) And 75%(9/12); The ORR for patients with PD-L1 TPS 1%-49% and ≥50% was 57%, respectively.(12/21) And 69%(9/13)In the treatment with a dose regimen of 10 mg/kg Q3W, 25 patients completed at least two efficacy evaluations.ORR was 72%(18/25)，DCR is 100%(25/25)。

In terms of safety, 78.3% of subjects experienced treatment-related adverse events. (TRAE), 24.1% of patients experienced ≥Grade 3 TRAEs. The most common TRAEs included hypercholesterolemia (18.1%, 15/83), hypertriglyceridemia (18.1%, 15/83), increased alanine aminotransferase (15.7%, 13/83), and increased aspartate aminotransferase (15.7%, 13/83). 6% of patients discontinued treatment due to TRAEs.

SSGJ-707 monotherapy has demonstrated promising efficacy in treatment-naïve advanced NSCLC with manageable safety. Trials for NSCLC monotherapy and combination therapy with chemotherapy are still ongoing.

On May 23, the ASCO official website showed that Disogene Medicine had independently developedFourth-generation EGFR TKIPhase I/II Study of DZD6008 in EGFR-Mutant NSCLC（TIAN-SHAN2 ,CTR20241790) Summary of results has been published.DZD6008 can fully penetrate the blood-brain barrier and effectively inhibit the growth of various EGFR mutant cells and tumor animal models.

Source: ASCO Official Website

TIAN-SHAN2 is a multi-center, first-in-human Phase I/II extension study designed to evaluate DZD6008 inSafety, Tolerability, and Antitumor Activity in EGFRm NSCLC Patients with Prior EGFR TKI Treatment Failure.

Preclinical studies have shown that DZD6008 exhibits equivalent potency against various single, double, or triple EGFR mutations and is over 50 times more selective for mutant EGFR than wild-type EGFR. In osimertinib-resistant EGFR triple mutation CDX and PDX models, DZD6008 significantly induced tumor shrinkage in a dose-dependent manner.

As of December 24, 2024, the dose-escalation cohort of the TIAN-SHAN2 study has enrolled 12 patients with EGFR-mutant NSCLC who are receiving DZD6008 treatment at doses ranging from 20 mg to 90 mg once daily (QD). The median age of the patients is 61 years, 67% are female, and 50% have an ECOG PS score of 1. All patients have adenocarcinoma and carry various types of single, double, or triple EGFR mutations. The median number of prior treatments is 5 lines.(Range: 2-8 lines)。All patients had received EGFR TKI and chemotherapy., including 11 patients who had received third-generation EGFR TKI treatment.

The results showed that DZD6008 was within the studied dose range.Well Tolerated, no dose-limiting toxicity was reported. The maximum tolerated dose was not reached in patients. DZD6008 demonstratedDose Proportionality（ dose-proportional ）And linear pharmacokinetic characteristics, with baseline brain metastases in patientsExcellent blood-brain barrier penetration(The ratio of cerebrospinal fluid to free plasma >1)。

Among 12 patients, 10 cases（83.3%）After receiving DZD6008 treatment,Target Lesion Tumor Reduction。Partial responses were observed in the ≥20 mg dose groups among patients carrying various EGFR mutations. Antitumor activity was observed in patients with brain metastases. The longest treatment duration was >6 months.(Treatment is still ongoing)。

May 23,CARsgen Pharma's Surizumab Olensale Injection（CT041）A Confirmatory Phase II Clinical Trial for Advanced Gastric Cancer/Esophagogastric Junction Cancer Conducted in China（CT041-ST-01, NCT04581473）The research results summary has been published on the ASCO website.。This is the first confirmatory randomized controlled trial in the field of solid tumor CAR-T conducted globally.

The study results showed that, in CLDN18.2-positive G/GEJC patients who failed at least second-line treatment, Suriceucel (Orelsocel) significantly improved PFS compared to standard treatment and demonstrated clinically meaningful OS benefits, with a manageable safety profile.

Source: ASCO Official Website

CT041-ST-01 is an open-label, multicenter, randomized controlled Phase II clinical trial conducted in China, aiming to compare the efficacy of Sur-Re CAR-T Injection with the current standard treatment.(Including Apatinib, Paclitaxel, Docetaxel, Irinotecan, or Nivolumab)In Claudin18.2-positive, at least second-line treatment failure advanced gastric/esophagogastric junction cancer（G/GEJC）Efficacy and safety in patients. The primary endpoint was the Independent Review Committee.（IRC）EvaluatedProgression-Free Survival (PFS), The key secondary endpoint isOverall Survival (OS). Data cut-off date: October 18, 2024.

From March 29, 2022 to August 16, 2024, a total of156 casesSubjects were randomly assigned to the CT041 group.（n=104）or TPC group（n=52）Among them, 20 subjects in the TPC group received subsequent CT041 treatment. All subjects had previously received at least second-line treatment, with 26.9% vs 19.2% of subjects in the CT041 group and TPC group having received at least third-line treatment; the proportion of Lauren diffuse/mixed type was 71.2% vs 65.4%; and the proportion of peritoneal metastasis was 69.2% vs 59.6%.

In the ITT, i.e., all randomized population: Based on IRC assessment, CT041 showed improvement over standard treatment.Significantly prolong PFS(mPFS 3.25 months vs 1.77 months; HR 0.366, 95% CI: 0.241, 0.557; p<0.0001), achieving the primary endpoint of this trial, patientsRisk of disease progression/death significantly reduced by 63%. MeanwhileOS Shows Significant Benefit Trend(mOS 7.92 months vs 5.49 months; HR 0.693, 95%CI: 0.457, 1.051; one-sided p=0.0416), even in the CT041 group 15.4%(16 cases)Failed to receive cell infusion, nearly 40% in the TPC group(20 cases)Under the subsequent administration of CT041 infusion, the risk of death in patients within the CT041 group still decreased by more than 30%.

More importantly, in the mITT, or actual medication population: a total of 136 subjects received the investigational drug, with 88 in the CT041 group and 48 in the TPC group. The mPFS evaluated by IRC was 4.37 months vs. 1.84 months for the CT041 group and TPC group, with an HR of 0.304.（95%CI：0.195，0.474）, the risk of disease progression/death decreased by 70%; mOS was 8.61 months vs 5.49 months, HR 0.601（95%CI：0385，0.939）, the risk of death decreased by 40%. The above results show that in patients who actually received cell infusion, the therapeutic benefit of CT041 was more pronounced.

Notably, the mOS of 20 subjects in the TPC group who received CT041 infusion reached 9.20 months. Among all 108 subjects who received CT041 infusion in both groups(In which CT041 group had 88 cases, and TPC group had 20 cases)mOS reached 9.17 months, while the mOS of the 28 patients in the TPC group who did not receive CT041 treatment was only 3.98 months.（HR: 0.288；95%CI：0169，0.492）. This further suggests that CT041 infusion can bring significant survival benefits to patients.

In terms of safety, the treatment with Surgyo InjectionWell tolerated overall, only 4 cases developed Grade 3 cytokine release syndrome（CRS）, no grade 4-5 CRS, no immune effector cell-associated neurotoxicity syndrome（ICANS）Occurrence.

 Heavyweight Pharmaceutical Deals

According to the Insight database, a total of 17 transaction events occurred this week (May 18 - May 24).

On May 20, 3SBio announced,WillPD-1/VEGF Bispecific Antibody SSGJ-707 Globally(Excluding mainland China)The exclusive rights for development, production, and commercialization were granted to Pfizer, with a total amount of up to 6.05 billion US dollars, includingThe upfront payment reached $1.25 billion, setting a new record for China's innovative drug exports.。

In addition, Pfizer will also subscribe for shares of 3SBio worth US$100 million, which fully demonstrates its confidence in...The emphasis on SSGJ-707. Affected by this news, the stock price of 3SBio increased by more than 35% during trading.

Source: 3SBio official website

• Why Can 3SBio’s PD1/VEGF Bispecific Antibody Fetch a Sky-High Price?
• Breaking Records! Chinese-Produced Drug Secures $43 Billion Mega Deal, Is Pfizer Really Worried?
  
  

2、$470 Million! Sanofi Acquires an Oral Small Molecule, Deepening Its Layout in the Field of Neurology

May 20,Jingyin Pharmaceuticals and CRISPR Therapeutics Announce Strategic Partnership to AdvancesiRNA TherapySRSD107 The co-development and commercialization process,Total transaction amount exceeds $8.95 billion。

Source:Jingyin Pharmaceuticals Official WeChat

SRSD107 is a new generation ofLong-acting siRNA Therapy, aimed at selectively inhibiting coagulation factor XI（FXI）FXI plays a key role in pathological thrombosis but has minimal impact on normal hemostatic function. By targeting FXI, SRSD107 is expected to reduce thrombotic events while significantly lowering the risk of bleeding, showing a distinction from Factor X activity.（FXa）Therapeutic Advantages of Inhibitors. SRSD107 has a wide range of potential indications, including atrial fibrillation and venous thromboembolism.（VTE）, tumor-associated thrombosis, end-stage renal disease patients undergoing hemodialysis, and populations undergoing major orthopedic surgery whose treatment options are limited due to bleeding risks.

Currently, SRSD107 has completed two Phase I clinical trials, showing good safety and tolerability in single-dose administration. Relevant research findings have been presented at the 2025 American College of Cardiology.（ACC）Released at the Annual Meeting and the 2024 American Society of Hematology (ASH) Annual Meeting. The Phase II clinical trial of SRSD107 is being initiated to evaluate its efficacy in preventing venous thromboembolism in patients undergoing knee replacement surgery.（VTE）Safety and efficacy. This study will provide clinical scientific evidence for confirming its anticoagulant clinical benefits and dose selection for subsequent pivotal trials.

May 22，NMPA official website shows that the KRAS G12C inhibitor co-developed by JAKS and Alis"GlaxoSmithKline"In ChinaApproved for Marketing(Acceptance No.:CXHS2400044），Used forPreviously received at least one line of systemic treatment for KRAS G12C-mutant locally advanced or metastatic non-small cell lung cancer（NSCLC）Treatment of adult patients.

Screenshot source:NMPA Official Website

Gore Rese（JAB-21822）Is a highly selective KRAS G12C inhibitor independently developed by JAB Biotherapeutics. Since its development, the drug has been recognized multiple times by the CDE.Included in the list of breakthrough therapies for three major types of cancer, respectively for:

• Previously received at least one systemic treatment(Up to no more than three lines of treatment)KRAS G12C Mutation Locally Advanced or MetastaticNSCLC；

• Previously treated with gemcitabine plus nab-paclitaxel or FOLFIRINOX regimen after disease progression, KRAS G12C mutation locally advanced or metastaticPancreatic Cancer；

• In combination with Cetuximab Injection for use after 2 lines of standard treatment(Including oxaliplatin, irinotecan, 5-fluorouracil, with or without anti-VEGF monoclonal antibody)Failure, KRAS G12C mutation-positive, locally advanced or metastatic unresectableColorectal Cancer。

In May 2024, GSK's first marketing application in China was accepted and approved this week through the priority review channel.

JACOB previously announced the Phase II registrational clinical trial data of Golarets at the ASCO Plenary Series.(Registration No.:NCT05009329/CTR20211470）This study evaluated the efficacy and safety of monotherapy with Gelelete in NSCLC patients who had previously received two or more lines of treatment.

Data as of March 28, 2024, with a median follow-up of 10.4 months. Among the 119 enrolled patients, the median age was 62 years, 80.7% had an ECOG PS score of 1, 16.8% had brain metastases, and 94.1% had previously received anti-PD-(L)1 therapy and platinum-based chemotherapy.

On May 21, the NMPA website showed that InnoCare's CD19 monoclonal antibody Tansitumomab（Tafasitamab）Approved for marketing and used forIn combination with lenalidomide for the treatment of relapsed/refractory patients who are not eligible for autologous stem cell transplantationDiffuse Large B-Cell Lymphoma（DLBCL）Adult patients. This indication was previously included in the priority review.

Screenshot source: NMPA official website

Tafasitamab is a humanized monoclonal antibody targeting CD19.Contains Xencor's proprietary engineered Fc domain, significantly enhancing antibody-dependent cell-mediated cytotoxicity.（ADCC）And antibody-dependent cellular phagocytosis（ADCP）, mediating the lysis of B-cell tumors through apoptosis and immune effector mechanisms.

In January 2020, MorphoSys and Incyte signed a collaboration and licensing agreement for the global development and commercialization of Tafasitamab. In February 2024, they reached a new agreement granting Incyte exclusive global rights for development and commercialization. In August 2021, InnoCare Pharma entered into a collaboration and licensing agreement with Incyte to obtain Tafasitamab.Exclusive Development and Commercialization Rights for Hematologic and Solid Tumors in Greater China。

In 2020 and 2021, Tafasitamab received approvals from the FDA and EMA respectively for second-line treatment of DLBCL. In 2022, the drug was applied for clinical trials in China for the first time, and in 2024, its marketing application was formally accepted by the CDE, and it was approved for marketing today.

At the 2024 EHA conference, InnoCare Pharma announced aTansitumab combined withPhase II Study of Lenalidomide in Relapsed or Refractory DLBCL（NCT05552937）Data. This is a single-arm, open-label, multi-center Phase II study designed to evaluateSafety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed or Refractory DLBCL.

Research data shows that tafasitamab combined with lenalidomide has demonstrated good tolerability and efficacy in the Chinese population, with preliminary efficacy and safety profiles consistent with the L-MIND study.

Data as of January 29, 2024, Independent Review Committee（IRC）EvaluationORR was 73.1%, including complete response（CR）The rate was 32.7%, partial response（PR）The rate was 40.4%.. Investigator-assessedORR was 69.2%, with CR and PR both at 34.6%.。

Insight database shows that currently, there are 7 CD19 monoclonal antibody pipelines under research globally.(Only active status is counted), only Nurick Health引进的Tansitumomaband Hosen Pharmaceutical introducedInebilizumabApproved for marketing. The latter isThe World's FirstThe CD19 monoclonal antibody approved for marketing in China has currently been approved.Neuromyelitis Optica and IgG4-Related Disease. AndTusamitamab is currently approvedDLBCL, isThe First Approved CD19 Monoclonal Antibody for Tumor Indications。

• For the primary endpoint, the median time to alleviation of seven influenza symptoms（TTAS）Compared with the placebo groupSignificantly shortened > 24 hours（39%）, where H1 subtype infected patients showed a significant reduction of > 32 hours compared to the placebo group.（44%）。
• In terms of secondary endpoints, the median time to fever resolution was shorter than in the placebo group.Significantly Reduced by 39%。The median TTAS and fever relief time in the Angladesivir group were nearly 10% shorter than those in the Oseltamivir group.
• In terms of virology indicators, withThe placebo group exists.Statistically significant differences indicate that Angladivir can achieve better and faster results.Reduce the viral load of influenza A，Significantly ShortenVirus Turn Negative Time，Reduce the Risk of Contagion。

• InIn terms of safety evaluation and drug resistance risk, Aoladewei also shows significant advantages.

On May 21, the official website of the National Medical Products Administration (NMPA) showed,Roche/Boehringer Ingelheim (BI)'s Tenecteplase Approved for Marketing. Based on clinical trial progress, the Insight database speculates thatInThrombolytic Therapy for Acute Ischemic Stroke（AIS）。

Source:NMPA Official Website

Early March this year, tenecteplaseAIS Indication Also Approved for Marketing in the U.S., Becoming the First Stroke Drug Approved by the FDA in Nearly 30 Years. This product is not a new therapy, 2000It was already launched in the U.S. in [Year] for the treatment of adult patients with acute ST-segment elevation myocardial infarction. 

Tenecteplase is a tissue plasminogen activator, clot dissolver, and thrombolytic agent administered as a single intravenous injection. (IV)Administered by injection,The administration time is five seconds.. Compared with the standard stroke treatment drug, alteplase(Intravenous push, infusion for 60 minutes)In comparison, tenecteplase is administered more quickly and simply.

In December 2023, Boehringer Ingelheim announced that the Phase III clinical trial of tenecteplase conducted in China, the ORIGINAL study, met its expectations. ORIGINAThe L study is a Phase III, multi-center, prospective, randomized, open-label, blinded-endpoint, positive-controlled parallel-group clinical trial, aimedIn ChinaAIS Evaluation of Tenecteplase in PatientsWith AlteplaseIn Stroke OccurrenceEfficacy and Safety within 4.5 Hours Post-Procedure。

The results showed,Within 4.5 hours after AIS symptom onset, tenecteplase is non-inferior to alteplase in achieving a good outcome (mRS 0 or 1) among Chinese patients eligible for intravenous thrombolysis, with similar safety profiles.

• In the aflibercept 8 mg every 16-week dosing group,77% of nAMD patients can maintain a 16-week dosing interval., an average of 5 injections at 48 weeks;
• In the aflibercept 8 mg every 12-week dosing group,79% of nAMD patients maintain a 12-week dosing interval, an average of 6 injections at 48 weeks.

Eylea 8 mg was approved for marketing by the US FDA in August 2023. Currently, Eylea 8 mg has been approved in more than 50 markets for the treatment ofnAMD andDiabetic Macular Edema (DME) 。

On May 21, the NMPA website showed that Hengrui Medicine's PD-1 monoclonal antibodyCamrelizumab Approved for an Indication, withFamitinib MalateCombined TherapyRecurrent or metastatic cervical cancer that has failed previous platinum-based chemotherapy。

Screenshot source: NMPA official website

This new indication approval is based on the positive results of a pivotal Phase II study, SHR-1210-II-217. This is aA randomized, open-label, controlled, multi-center Phase II clinical study aimed at evaluating the efficacy and safety of camrelizumab combined with famitinib malate versus camrelizumab monotherapy or investigator's choice of chemotherapy in the treatment of recurrent or metastatic cervical cancer.

Data from studies presented at the 2023 ESMO Congress showed:

• Camrelizumab Combined with Famitinib GroupMedian PFS was 8.1 months (95% CI：6.2-12.4), Camrelizumab Monotherapy GroupMedian PFS was 4.1 months (95% CI：2.1-5.1), the chemotherapy group selected by the researchersMedian PFS was 2.9 months (95% CI：2.0-6.2)；

• As of September 25, 2023,The median OS in the three study groups was 20.6 months, 14.9 months, and 13.9 months, respectively.；

• The ORR of the camrelizumab plus famitinib group assessed by BICR was 41%, with an ORR of 46.9% in the squamous cell carcinoma subgroup, 29.2% in the non-squamous cell carcinoma subgroup, 44.6% in the PD-L1 positive expression subgroup, and 40.0% in the PD-L1 negative expression subgroup.

Moreover, regardless of the patient's pathological type or PD-L1 expression, compared with the camrelizumab monotherapy group and the chemotherapy group, the PFS in the camrelizumab plus famitinib group showed significant benefit.

In terms of safety, the more common TRAEs in the camrelizumab plus famitinib group were decreased white blood cell count, decreased neutrophil count, anemia, proteinuria, etc., with no new safety signals identified.

Camrelizumab is a humanized antibody independently developed by Hengrui Medicine.PD-1 Monoclonal AntibodyThe Insight database shows that Camrelizumab has previously received 9 approvals in China, with indications involvingLung cancer, liver cancer, esophageal cancer, nasopharyngeal cancerAndLymphoma，Including 5 first-line therapies. This time isCamrelizumab Receives 10th Approval for Marketing in China.

Screenshot source: NMPA official website

At the 2024 ESMO Congress, Chiatai Tianqing announced the Phase III clinical study of this combination therapy for first-line treatment of advanced RCC.（ETER100）Latest results. This is a randomized, open-label, positive drug parallel-controlled, multi-center Phase III clinical study aimed at evaluating the efficacy and safety of Beianlotinib combined with Bemusumab compared to the control group as first-line treatment for advanced unresectable or metastatic RCC.The primary endpoint is PFS.。

Data shows,Anlotinib Combined with Bevacizumab Group and Control GroupThe median PFS was 18.96 months and 9.76 months, respectively., the combination therapy significantly extended PFS.

Compared with the control group,Anlotinib Combined with Bevacizumab GroupSignificantly improved patient ORR(ORR was 71.6%), the ORR in the control group was 25.1%. Additionally, the combination therapy group showed a trend towards OS benefit.

On May 22, the CDE official website showed,Anshi Pharmaceuticals' ApplicationThird-generation EGFR-TKI「Andatinib Benzoate Capsules(PLB1004 Capsule)Accepted by CDE forTreatmentPatients with locally advanced or metastatic NSCLC who have experienced disease progression during or after treatment with platinum-based chemotherapy and/or PD-1/PD-L1 immune therapy, or are intolerant to these treatments, and have been confirmed by testing to have EGFR exon 20 insertion mutations.Patient.This indication was previously included in the priority review by the CDE.

On May 20, the CDE website showed that BMS'sDeucravacitinib Tablets New Indication Marketing Application AcceptedBased on the progress of clinical trials, the indication is speculated to be psoriatic arthritis.

Deucravacitinib is a tyrosine kinase 2（TYK2）Inhibitor,By selectively targeting TYK2 to inhibit the signaling of IL-23, IL-12, and IFN, these cytokines are key factors involved in the pathogenesis of various immune-mediated diseases.

DeucravacitinibAchieved by binding to the regulatory domain of TYK2Highly Selective, leading to the allosteric inhibition of TYK2 and its downstream functions. Within the physiological concentration range, this productSelective inhibition of TYK2 at therapeutic dosesDoes not inhibit JAK1, JAK2, or JAK3.

October 2023,Deucravacitinib inFirst approved for marketing in China, for the treatment ofAdult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy。

In March this year, BMS announcedDeucravacitinib TreatmentPhase III of Active Psoriatic ArthritisPositive Results from the POETYK PSA-2 Trial. The study met its primary endpoint, namely,ACR20 in Patients Treated with Deucravacitinib(Signs and symptoms of the disease improved by at least 20%)The response rate was significantly higher than that of the placebo group.(54.2% vs. 39.4%, respectively; p=0.0002)During the 16-week treatment period,DeucravacitinibThe overall safety profile is consistent with previous clinical trials.

Cyclosporine Ophthalmic Gel isZhaoke Ophthalmology develops for ChinaTreatment of Moderate to Severe Dry Eye SyndromeThe innovative cyclosporine gel. Unlike the Restasis emulsion formula, the cyclosporine ophthalmic gel is a patented hydrogel, with its patent rights already approved in China and internationally. This innovative formulation enhances the pharmacokinetic efficacy and exposure of cyclosporine on the ocular surface.Giving Cyclosporine More Time to Suppress Dry Eye Syndrome。

Results from the previous Phase II study showed,0.05% Cyclosporine Ophthalmic Gel(Once daily in the evening)The efficacy and safety profile are at least comparable to Restasis(0.05% Cyclosporine, Twice Daily)Similar, effectively eliminating the need for daytime dosing and the associated discomfort and inconvenience.

In addition, byPhase III Study Conducted by Zhejiang Ophthalmology(COSMO)The results showed that cyclosporine ophthalmic gelMay take effect as early as two weeks.With once-daily dosing and rapid onset of action, it is expected to significantly improve patient medication adherence and quality of life.

On May 20, the CDE website announced that CARsgen Therapeutics' Class 1 new drugSurgeoluce InjectionProposed for inclusion in priority review for the treatment of CLDN18.2-positive patients who have failed at least two prior lines of therapy.Advanced Gastric/Esophagogastric Junction Adenocarcinoma. GSK previously stated that it is expectedWill submit the drug's marketing application to the NMPA in the first half of this year.。

Insight database shows that no CAR-T has been approved globally for the treatment of solid tumors. CARsgen's Surrogate Goleucel is in the first tier in this field.Expected to become the world's first CAR-T product for solid tumors to be marketed.。

Source: CDE Official Website

Surgeioluce（CT041）It is a Claudin18.2-targeted therapy developed by Carsgen Therapeutics.（CLDN18.2）Autologous CAR-T cell therapy, intended for the treatment of Claudin18.2-positive solid tumors, primarily gastric cancer/esophagogastric junction adenocarcinoma, and pancreatic cancer.

Suruji Orel赛 has received several special designations for advanced gastric cancer/esophagogastric junction adenocarcinoma: In the United States, it has been granted the FDA's "Regenerative Medicine Advanced Therapy" designation and Orphan Drug status; in China, in February this year, the CDE included the gastric cancer indication of Suruji Orel赛 as a breakthrough therapy.

Insight database shows that, in the track of EZH2-targeted drugs produced in China, a total of 3 pipelines have entered the clinical stage.Hengrui SHR2554 is the fastest-progressing, already in the marketing application stage, with the first indication beingPeripheral T-Cell Lymphoma, once wasCDE Included in Breakthrough Therapy；Cigna XNW5004 Phase II, currently in Phase III clinical stage;CASPRTR115 is still in Phase I clinical trials.

Click the card to enterInsight Mini Program

Review Progress in China, Global New Drug Development…

Check anytime, anywhere!