Chinese Pharma Giants Advance Multiple Innovative Drugs into Pivotal Phase III Trials

Oct 22, 2024 15:17 CST Updated 15:17

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LaunchⅢ Phase clinical trials mean that the new drug development is one big step closer to market. October(Data Range 10.1-10.22), multiple China-produced innovative drugs enter a critical phaseⅢPhase clinical trials, these new drug developments involveHengrui, Hansoh Pharma、CHIATAI TIANQING, Ascentage Pharma,Yiming Angke Biomedical Technology(Shanghai) Co., Ltd.Yilian BioAmong these companies, we have selected some key projects to share with you.

Hengrui Initiates Two GLP-1R AgonistsⅢPhase Clinical

For Type 2 Diabetes

On October 21, Hengrui launched a project for HRS9531 in China for type 2 diabetes.Phase III ClinicalBed Study.

Screenshot source: CDE official website

HRS9531 is a GLP-1/GIP dual receptor agonist developed by Hengrui, currently under investigation for indications including obesity, type 2 diabetes, polycystic ovary syndrome, and heart failure with preserved ejection fraction combined with obesity, among which, forObesity and Type 2 Diabetes Have Progressed to Phase ⅢClinical Stage。

On October 15, Hengrui launched a clinical trial for Noliglutide Injection in China.（SHR20004）For Type 2 DiabetesⅢPhase clinical.

Screenshot source: CDE official website

Noliglapeptide is a GLP-1 receptor agonist administered once daily via subcutaneous injection. The main indications under research currently are obesity and type 2 diabetes, among which,Obesity indication is currently in Phase II clinical trials.。

Yiming Angke "Tidapasep"
First Launch of Phase III Clinical Trial for Chronic Monocytic Leukemia

On October 18, Yiming Angke Biomedical Technology(Shanghai) Co., Ltd. registered a Phase III clinical trial in China on the Clinicaltrial website.（NCT06647862）, aiming to evaluateTidrapipag CombinationAzacitidineTreatment of Newly Diagnosed Chronic Monocytic Leukemia with Placebo Combined with Azacitidine（CMML1-2）Efficacy and safety of patients.

Screenshot source: Clinicaltrials

Tidapipesib（IMM01）It is independently developed by Yiming Angke Biomedical Technology(Shanghai) Co., Ltd.Next-Generation CD47-Targeting Molecules. This drug has a dual mechanism, which can not only block the "don't eat me" signal from tumors but also activate the "eat me" signal of the patient's immune system through IgG1. Previously, the drug has been launched in China forThird-line Treatment for Classical Hodgkin LymphomaThe pivotal Phase III clinical trial.

This launch marks the first Phase III clinical trial of Tidapacip for chronic myelomonocytic leukemia. The Phase II study results, orally presented at this year's ESMO, showed that Tidapacip in combination with Azacitidine demonstrated good efficacy and tolerability in treatment-naive patients with chronic myelomonocytic leukemia: patients treated for ≥4 months.TotalOverall Response Rate (ORR) was 87.5%, with a Complete Response Rate (CR) of 37.5%.; Patients treated for ≥6 months,ORR was 84.6%, CR was 46.2%。

Hengrui Claudin18.2 ADC

First Launch of Phase III Clinical Trial for Gastric Cancer

On October 18, Hengrui registered a Phase III clinical trial in China on the Clinicaltrial website.（NCT06649292）, to compare SHR A1904 with the treatment chosen by the investigator inClaudin18.2-positive second-line advanced or metastatic gastric or gastroesophageal junction adenocarcinomaEfficacy in patients.

Screenshot source: Clinicaltrials

SHR-A1904 is independently developed by Hengrui. Claudin 18.2 ADCIn October last year, Merck Germany secured the exclusive rights for the development, manufacturing, and commercialization of SHR-A1904 and another product from Hengrui, HRS-1167 (a second-generation PARP inhibitor), outside mainland China through a collaboration deal worth up to 1.4 billion euros with Hengrui.

At this year's ESMO Annual Meeting, Hengrui announced for the first time the Phase I study results of SHR-A1904 in the treatment of gastric or gastroesophageal junction cancer (GC/GEJC). The data showed that, among patients with baseline and ≥1 post-baseline assessment, in the 6.0 mg/kg dose group,ORR and DCR were 55.6% respectively.(5/9) And 88.9%(8/9); 8.0 mg/kg dose group,ORR and DCR were and 36.7%, respectively.(11/30) and86.7% (26/30)。

Ascentage Pharma Bcl-2 Inhibitor

First Launch of MDS Indication Phase III Clinical Trial

On October 15, Ascentage Pharma registered a global multi-center Phase III clinical trial on the Clinicaltrial website (NCT06641414，GLORA-4), which will be conducted in the United States and mainland China to evaluate Lisaftoclax(APG-2575) In combination with Azacitidine(AZA)TreatmentNewly Diagnosed High-Risk Myelodysplastic Syndrome (HR-MDS) PatientThe efficacy of the treatment, with the control group receiving a placebo combined with azacitidine.

Screenshot source: Clinicaltrials

APG-2575 is independently developed by Ascentage.Novel Oral Bcl-2 Selective InhibitorPreviously, the drug had initiated two pivotal Phase III clinical trials, targeting indications respectively.Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (first-line), Acute Myeloid Leukemia (first-line)。

At the 2023 ASH Annual Meeting, Ascentage Pharma presented safety, pharmacokinetics (PK), and efficacy data for APG-2575 used alone or in combination with azacitidine or homoharringtonine in adult patients with AML, MDS, or other myeloid tumors. Among them,Subgroup data for MDS patients showed an ORR of 70.0% and a CR/CRi rate of 60.0%.。

Hansoh Pharma TYK2 Inhibitor

Launch the First Phase III Clinical Trial

On October 14, Hansoh Pharma registered a Phase III clinical trial in China.（CTR20243822）, to evaluate HS-10374 in the treatment of adultsPatients with moderate to severe plaque psoriasisefficacy and safety. This is also the first pivotal Phase III registration clinical trial initiated for HS-10374.

Screenshot source:CDE Official Website

HS-10374 is a self-developed product by Hansoh Pharma.Tyrosine Kinase 2（TYK2）Selective Allosteric Inhibitor. At the 33rd Annual Conference of the European Academy of Dermatology and Venereology held in October this year（EADV 2024）Above, Hansoh Pharma orally presented the data from the Phase II clinical study of HS-10374 for psoriasis:

In terms of PASI75 response rate,HS-10374 6 mg group was 28.6%（P=0.013），72.1% for the 12 mg group（P<0.001），Significantly higher than 7.5% in the placebo group，Achieve the primary endpoint；
HS-10374 6 mg Group and 12 mg GroupsPGA 0/1 response rates (33.3% and 65.1%, respectively) were also significantly higher than those in the placebo group (10.0%).。
In addition, HS-10374 has demonstrated good safety in the treatment of psoriasis.

CHIATAI TIANQING Launches RofacitinibⅢPhase Clinical

For Graft-Versus-Host Disease

On October 11, CHIATAI TIANQING launched a new Class 1 drug.ⅢPhase clinical study to evaluate the efficacy of Rovasitinib compared with investigator-selected regimens inSevere Chronic Graft-Versus-Host Disease in Third-Line and BeyondEfficacy and safety in China.

Screenshot source: CDE official website

Rovactinib is a JAK/ROCK inhibitor with a novel chemical structure,On July 13 this year, it was the first time in China to file for marketing authorization for the treatment of intermediate- and high-risk myelofibrosis.。

CHIATAI TIANQING presented data from the Ib/II phase clinical study at the 2023 EHA Annual Meeting, showing that Rovatinib is tolerable in terms of toxicity for patients with cGVHD.The best objective remission rate for each graft rejection site was 86.7%, 40% of patients had an LSS score improvement of ≥7 points, and 73.3% of patients reduced their steroid dosage.`, which is expected to bring more clinical treatment options for cGVHD patients.`

3SBio Initiates IL4R Monoclonal AntibodyⅢPhase Clinical

For chronic sinusitis with nasal polyps

On October 10, the CDE official website showed,3SBioRegister a study in chronic rhinosinusitis with nasal polyps（CRSwNP）A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SSGJ-611 in SubjectsⅢPhase Clinical Study.

Screenshot source: CDE official website

SSGJ-611 is an IL-4Rα antagonist independently developed by 3SBio Guojian. On August 9 this year, 3SBio Guojian announced that the Phase II clinical study of SSGJ-611 for the treatment of chronic rhinosinusitis with nasal polyps had met its primary endpoint.

The results showed that, at week 16 of treatment, the bilateral nasal endoscopy polyp scores in both dose groups（NPS）Changes from baseline were -2.12 and -1.61, respectively., Weekly Average Nasal Congestion Score（NCS）Changes from baseline were -1.11 and -1.16, respectively.。

Compared with dupilumab, a drug targeting the same point that has been listed abroad, in clinical studies treating adult CRSwNP subjects(SINUS-24 and SINUS-52 Studies), the NPS at Week 24 decreased by -1.89 and -1.71 from baseline, respectively. It can be seen that the therapeutic response of SSGJ-611 in CRSwNP subjects at Week 16...Similar response to dupilumab at week 24, or even showing a trend of higher efficacy(This is not a head-to-head comparative study), indicating that SSGJ-611 has significant potential to improve CRSwNP disease.

Yilian Bio B7-H3 ADC

Initiate Nasopharyngeal CarcinomaⅢPhase Clinical

On October 8, Yilian Biotech registered a clinical trial for YL201 in the treatment of nasopharyngeal carcinoma on Clinicaltrials.（NPC）Third-line/Last-line TherapyⅢPhase Clinical,This is the second new drug launch after small cell lung cancer.Phase ⅢClinical Research。

Screenshot source: Clinicaltrials

YL201 is an ADC targeting B7-H3, featuring a tumor microenvironment-activatable linker and a novel topoisomerase I inhibitor payload.

At this year's ESMO Congress, Yilian Biotech announced the preliminary clinical results of YL201 in solid tumor patients. Among them, the NPC cohort included 70 evaluable patients, all of whom had previously received platinum-based chemotherapy and anti-PD-(L)1 therapy, with 75% having undergone two or more lines of standard treatment.

YL201 in NPC PatientsORR was 48.6%(≥2.0 mg/kg ORR was 48.6%)，mPFS was 7.2 months(≥2.0 mg/kg mPFS was 7.2 months)。In patients who received two or more lines of standard treatment, the ORR was 51.0%, and the mPFS was 7.0 months, comparable to the overall NPC population.。

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