Hansoh Pharma, 3SBio, and SL Pharmaceutical Receive NMPA Approvals for New Drug Launches

EO Intelligence Healthcare Weekly Pharma News,Hansoh Pharmaceutical's Olanzapine, 3SBio's Inetetamab, and Double-Crane Pharmaceutical's Ademetionine Disulfate TosylateApprovedListing; Conba's Compound Sulfamethoxazole Tablets, Qilu Pharmaceutical's Cefprozil Granules, and CSPC's Bortezomib for Injection have passed the consistency evaluation.

In addition, clinical trial approvals were granted for six drugs, marketing applications or clinical trial applications for two drugs were accepted, new indications for two drugs were approved, and significant progress was made in the development of eight drugs.

Approved for Market Launch

1. Hansoh Pharmaceutical’s “Olanzapine Orally Disintegrating Tablets” Approved

Hansoh PharmaceuticalAnnouncement Issued on June 22 Regarding Its SubsidiaryJiangsu Hansoh Pharmaceutical Group Co., Ltd.DevelopedOlanzapine Orally Disintegrating TabletsThe drug registration approval has been granted by the NMPA. This product is an atypical antipsychotic medication indicated for the treatment of schizophrenia.

For patients who respond to initial olanzapine therapy, consolidation treatment can effectively maintain the improvement in clinical symptoms; it is used to treat moderate to severe manic episodes; for patients with manic episodes who respond to olanzapine treatment, olanzapine can prevent the recurrence of bipolar disorder.

2. GenSci's HER2 Monoclonal Antibody Approved

June 19,3SBio Inc.Self-developedInetetamabApproved by the NMPA for market launch under the brand name Saiputing® for the treatment of HER2-positive metastatic breast cancer.This product is the first domestically self-developed HER2 monoclonal antibody in China., it is part of the National 863 Program, the National Major New Drug Creation Project, and the Shanghai Key Science and Technology Research Project, and is also designated as a priority review drug.

As of now, four monoclonal antibody biosimilars have been approved in China, involving six companies. Specifically, there are two adalimumab injections: Bio-Thera’s Geleli® and Hisun’s Anjianning®; two bevacizumab injections: Qilu Pharmaceutical’s Ankeda® and Innovent’s IBI-305 (note: originally stated as adalimumab injection in the source text, but corrected to reflect accurate product association); one rituximab injection from Henlius’ Hanlikang®; and one trastuzumab for injection from 3SBio’s Saiputing®.

3. Shuanglu Pharmaceutical’s Ademetionine 1,4-Butanedisulfonate for Injection Approved

Beijing Double-Lu Pharmaceutical Co., Ltd.Recently received the approval and issuance from NMPAAdemetionine Disulfate APIFiling and Drug Registration Approval for Ademetionine 1,4-Butanedisulfonate for Injection.

Ademetionine 1,4-butanedisulfonateIt is a Class B medical insurance product, clinically used primarily for the treatment of intrahepatic cholestasis associated with pre-cirrhotic and cirrhotic conditions, as well as intrahepatic cholestasis of pregnancy.

Consistency Evaluation

1. Conba’s Compound Sulfamethoxazole Tablets Pass the Consistency Evaluation

June 23,ConbaAnnouncement Issued by Its Controlled SubsidiaryZhejiang Jinhua Conba Bio-Pharmaceutical Co., Ltd.Received the NMPA-issued approval regardingCompound Sulfamethoxazole Tablets“Supplementary Drug Application Approval,” and the drug has passed the generic drug consistency evaluation.

Compound Sulfamethoxazole Tablets are sulfonamide antibacterial agents, which are a compound preparation of sulfamethoxazole (SMZ) and trimethoprim (TMP).Included in the "National Reimbursement Drug List (2019 Edition)" as a Class A drug, This drug is mainly used to prevent or treat infections caused by susceptible bacterial strains.Conba is the first domestic company to pass the quality consistency evaluation for this drug in China.

2. Qilu Pharmaceutical’s Cefprozil Granules Become the First in China to Pass the Consistency Evaluation

RecentlyQilu PharmaceuticalReceived the approval and issuance from the NMPACefprozil Granules(Trade name: Yidai) The approval for the supplementary drug application marks that this product is the first in China to pass the consistency evaluation.

Data shows that cefprozil is a second-generation oral cephalosporin that exerts its bactericidal effect by inhibiting bacterial cell wall synthesis. To date, Qilu Pharmaceutical has had 33 products pass the consistency evaluation, of which 20 were the first in China.

3. CSPC Pharmaceutical Group’s Anti-tumor Drug Passes Consistency Evaluation

On June 19, the NMPA official website announced,CSPC Pharmaceutical GroupClass 4 Marketing Authorization ApplicationBortezomib for InjectionApproved. It is reported that this isChina's First Bortezomib for Injection Product to Pass the Consistency Evaluation

Bortezomib is a reversible inhibitor of the chymotrypsin-like activity of the 26S proteasome in mammalian cells. The 26S proteasome is a large protein complex that degrades ubiquitinated proteins. The ubiquitin-proteasome pathway plays a critical role in regulating the intracellular concentration of specific proteins, thereby maintaining cellular homeostasis. Proteolysis affects multiple intracellular signaling cascades; disruption of this normal homeostatic mechanism can lead to cell death. Inhibition of the 26S proteasome prevents such targeted proteolysis.

Approved for Clinical Trial

1、Fuchuang Medicine's Two Class 1 Anti-tumor DrugsNew DrugApproved for Clinical Trials

Recently, the CDE official website shows that,Fosun PharmaHolding SubsidiaryFuchuang MedicineTwo Class 1 New Drugs: FCN-159 Tablets and FCN-011 CapsulesEach received two investigational new drug (IND) approvals for clinical trials: FCN-159 is a MEK inhibitor approved for clinical development.Indicationsfor “type 1 neurofibromatosis requiring systemic treatment”; FCN-011 is a small-molecule chemical drug, with the approved clinical indication being “intended for use in patients with NTRK gene fusion-positive solid tumors.”

FCN-159 is a novel, highly potent mitogen-activated protein kinase kinase (MEK) inhibitor independently developed by Fuchuang Pharmaceutical. It is being developed as both a monotherapy and in combination regimens for the treatment of solid tumors. Previously, the drug received approval in China for two clinical studies targeting the indication of “monotherapy or combination therapy with other antineoplastic agents for advanced solid tumors harboring BRAF or RAS mutations.” The clinical trial approved this time targets a new indication: “neurofibromatosis type 1 requiring systemic therapy.”

2. Hengrui Medicine Receives Clinical Trial Approval for SHR2285 Tablets

June 24,Hengrui Medicineannounced in a public announcement,SHR2285 TabletsApproved to conduct Phase I clinical trials.This drug is proposed for the prevention or treatment of arteriovenous thrombosis, as well as reducing the risk of thromboembolism caused by interventional therapy or extracorporeal circulation.

Upon inquiry, it has been found that similar products are currently in the clinical trial stage. No similar products have been approved for marketing domestically or internationally, and there is no relevant sales data available. As of now, approximately RMB 38.89 million has been invested in the research and development of this product project.

3. Hengrui Medicine’s Class 1 Innovative Drugs, HRS9950 Tablets and HRS5091 Tablets, Approved for Clinical Trials

On June 23, the CDE public notice information shows that,Hengrui Medicine’s Class 1 Innovative Drugs: HRS9950 Tablets and HRS5091 TabletsClinical trial approval granted. Information on the CDE website indicates that this marks the first clinical trial approval for these two drugs in China, with Hengrui Medicine planning to develop them for the treatment of chronic hepatitis B.

4. Hengrui Medicine’s SHR0302 Alkaline Ointment Approved for Clinical Trials for a New Indication

On June 23, the CDE public notice information showed that,Hengrui Medicine’s JAK1 Kinase-Selective Inhibitor SHR0302 Base OintmentNew Indication Approved for Clinical Trials, Intended for the Treatment of Vitiligo. Submitted by Rishi Biotherapeutics, a subsidiary of Hengrui Medicine. Research has found that overactivity of the JAK signaling pathway is closely associated with inflammation in the pathogenesis and progression of vitiligo. Therefore, JAK inhibitors are expected to provide a new treatment option for patients with vitiligo.

5. Zhifei Biological Products' Novel Coronavirus Vaccine Receives Approval for Clinical Trials

June 23,Zhifei Biologicalannounced in a public notice that,Zhifei LongkemaandInstitute of Microbiology, Chinese Academy of SciencesCo-developedRecombinant Novel Coronavirus Vaccine (CHO Cells)Clinical Trial Application Accepted.

This vaccine is a prophylactic biological product used to prevent coronavirus disease 2019 (COVID-19) caused by 2019-nCoV. Results from animal protection studies demonstrated that vaccination induced high levels of neutralizing antibodies, significantly reduced viral load in lung tissue, alleviated lung injury caused by viral infection, and provided substantial protective efficacy.

6、AltimmuneSlowSexBHepTcell, a Liver Immunotherapy Drug, Receives FDA Approval for Phase II Clinical Trials

Clinical-stage Biopharmaceutical CompanyAltimmuneRecently announced that the FDA has approved its immunotherapy drug for the treatment of chronic hepatitis BHepTcell Investigational New Drug (IND)Application for Phase II Clinical Trial.

Altimmune has also submitted clinical trial applications in Canada, Spain, Germany, and the United Kingdom. The company plans to initiate a multinational clinical trial in the fourth quarter of this year. Given the current COVID-19 pandemic situation in Europe, Altimmune stated that it will continue to assess the impact of the pandemic on research activities.

Accepted

1. Luye Pharma’s Investigational New Drug Application for LPM4870108 Tablets Officially Accepted by the CDE

June 23,Luye PharmaAnnounced that it has discovered for the first time a synthesized compound with independent intellectual property rightsNovel Class 1 NTRK Small-Molecule Inhibitor LPM4870108 TabletsThe clinical trial application has been formally accepted by the CDE. This product is indicated for the treatment of patients with NTRK fusion-positive cancers across various tumor types, as well as patients who have developed resistance to first-generation NTRK inhibitors.

NTRK gene fusions are well-established oncogenic drivers, identified in more than 20 types of solid tumors in both adults and children, including lung cancer, colorectal cancer, thyroid carcinoma, and fibrosarcoma. After a period of treatment with first-generation marketed NTRK inhibitors, the majority of patients develop acquired resistance mutations, primarily including NTRK1-G595R, NTRK2-G639R, and NTRK3-G623R. Currently, no second-generation inhibitors targeting these mutations have been approved for marketing.

2. BeiGene’s PD-1 Inhibitor Tislelizumab: Marketing Application for Fourth Indication Accepted

On June 24, the CDE released its latest public announcement,BeiGeneUnder the banner ofTislelizumab Injection, a Novel PD-1 Antibody DrugSubmitted a new indication marketing application, which was accepted.

It is worth noting that this represents the fourth indication submitted to the National Medical Products Administration (NMPA) for this drug. Previously, the drug was approved in China for the treatment of Hodgkin’s lymphoma and urothelial carcinoma, and its third indication—first-line treatment for advanced squamous non-small cell lung cancer—was also submitted in April this year.

Indication Approved

1. Merck’s Anti-PD-1 Therapy Keytruda Receives FDA Approval for New Indication

On June 25, the FDA announced approvalMerck & Co.'s PD-1 Inhibitor Keytruda(pembrolizumab) expanded indication for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation therapy.

This approval marks the first indication for Keytruda in cSCC. The approval is based on data from the Phase II KEYNOTE-629 (NCT03284424) trial, a multicenter, multi-cohort, non-randomized, open-label study that enrolled 105 patients with cSCC. Of these, 87% had received one or more prior therapies, 74% had previously undergone radiation therapy, 45% had only locally recurrent cSCC, 24% had only metastatic cSCC, and 31% had both locally recurrent and metastatic cSCC. In the study, patients received 200 mg of Keytruda via intravenous infusion every three weeks until disease progression, unacceptable toxicity, or up to a maximum of 24 months of treatment. The median duration of exposure to Keytruda in this trial was 5.8 months (range: 1 day to 16.1 months).

2. Merck’s PD-1 Inhibitor Pembrolizumab Approved for New Indication in China

On June 19, the NMPA official website announced that,Merck’s PD-1 monoclonal antibody drug Keytruda (Keytruda (pembrolizumab) Approved in China for New Indication: Treatment of Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) with PD-L1 Positivity (Combined Positive Score [CPS] ≥10) Following Failure of Prior First-Line Systemic Therapy

Keytruda is currently the PD-1 monoclonal antibody with the largest number of approved indications (five) in China. This approval also marks its first indicated use in the gastrointestinal field in China. On July 31, 2019, Keytruda was approved by the U.S. FDA for the treatment of PD-L1-positive (CPS ≥10) recurrent locally advanced or metastatic esophageal squamous cell carcinoma, becoming the first immunotherapy drug approved globally for esophageal cancer and ushering in the era of immunotherapy for this disease.

Key Trial Progress

1. The World’s First International Phase III Clinical Trial for an Inactivated COVID-19 Vaccine Officially Launches

June 23,Sinopharm GroupChina BiopharmaceuticalsInactivated COVID-19 VaccineThe launch ceremony for the international Phase III clinical trials in the United Arab Emirates was held simultaneously via video conference in Beijing and Wuhan, China, and Abu Dhabi, UAE. During the ceremony, the UAE Minister of Health presented the clinical trial approval document to China National Biotec Group (CNBG). The Chinese and Emirati parties signed relevant clinical cooperation agreements on-site, marking the official launch of the first global international Phase III clinical trials for an inactivated COVID-19 vaccine.

2. Merck’s Two Phase 3 Clinical Trials of 15-Valent Pneumococcal Conjugate Vaccine V114 in Adults Achieve Success

Merck & Co.Recently announced the evaluation of investigational15-valent pneumococcal conjugate vaccine V114Results from two Phase III clinical studies on safety, tolerability, and immunogenicity demonstrated that V114 met both the safety and immunogenicity endpoints.

The PNEU-WAY (V114-08) study, conducted in adults aged 18 years and older living with HIV, demonstrated that V114 elicited immune responses against all 15 serotypes included in the vaccine, including serotypes 22F and 33F. The PNEU-FLU (V114-021) study, conducted in healthy adults aged 50 years and older, showed that V114 can be co-administered with the quadrivalent influenza vaccine. The results of these two studies, along with those from the V110-029 study evaluating the multivalent pneumococcal vaccine Pneumovax®23 in healthy adults aged 50 years and older, were recently published in the online digital library of the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD).

3. Johnson & Johnson’s Investigational New Hepatitis B Drug JNJ-3989 (ARO-HBV) to Undergo Quadruple Therapy Study in Hepatitis B Carriers

Recently,Johnson & JohnsonJanssen, a subsidiary, has initiated a Phase II clinical trial of the investigational new hepatitis B drug JNJ-3989 (AROHBV) + the investigational new hepatitis B drug JNJ-6379 + nucleos(t)ide analogs (NA) +/- PegIFN-α2a.

JNJ-3989 (ARO-HBV) is an investigational subcutaneously injected novel hepatitis B drug developed using RNAi technology, while JNJ-56136379 is an oral capsid assembly modulator (CAM) under development for the treatment of chronic hepatitis B. In this trial, the nucleos(t)ide analog used was tenofovir disoproxil fumarate (TDF). Based on the combination of these three drugs, some subjects will additionally receive pegylated interferon alfa-2a (PegIFN-α2a) for quadruple therapy.

4. Lee's Pharmaceutical Announces Key Phase III Trial for Investigational Dermatology Product

June 22Lee's PharmaceuticalAnnouncement Issued by Its SubsidiaryCOPFLSuccessfully completed in China for its use in treating moderate acne vulgarisAdapalene-Clindamycin Compound Gelof the pivotal Phase III trial.

Key data from the pivotal Phase III trial demonstrated that the study met its primary endpoint, proving ACCG to be superior to adapalene gel or clindamycin gel monotherapy with high statistical significance (P<0.0001). The New Drug Application was expected to be submitted in the second half of 2020, with marketing approval anticipated in 2021.

5. Full Results of AstraZeneca’s Phase III ETHOS Clinical Trial for Breztri Aerosphere Released

June 24,AstraZeneca Budesonide/Glycopyrronium/FormoterolPhase III ETHOS Clinical Trial Announces Full Positive Results.

Trials have demonstrated that, in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), AstraZeneca’s triple therapy Breztri® Aerosphere® (budesonide/glycopyrronium/formoterol fumarate) significantly reduces the incidence of moderate-to-severe acute exacerbations compared with two dual-therapy regimens. These findings have been published in The New England Journal of Medicine and were also presented during the clinical trials session on pulmonary medicine at the American Thoracic Society International Conference.

6. Roche’s Ipatasertib Meets One Primary Endpoint in Phase 3 Clinical Trial for Prostate Cancer

Rocheunder the banner ofGenentechRecently Announced Phase III Clinical StudyIPATential150The study met one of the co-primary endpoints: compared with the current standard of care (abiraterone plus prednisone/prednisolone) plus placebo, ipatasertib combined with the standard of care prolonged radiographic progression-free survival (rPFS) in patients with metastatic castration-resistant prostate cancer (mCRPC) harboring PTEN loss. However, the study did not meet the other co-primary endpoint of extending rPFS; thus, the overall results were mixed.

IPATential150 is a double-blind, placebo-controlled, randomized Phase 3 clinical study that enrolled 1,101 male patients to evaluate the efficacy and safety of iptasertib in combination with standard of care in adult male patients with asymptomatic or mildly symptomatic, previously untreated metastatic castration-resistant prostate cancer (mCRPC). The co-primary endpoints included radiographic progression-free survival (rPFS) in the overall study population and rPFS in the subgroup of patients with PTEN gene loss assessed by immunohistochemistry. Progression-free survival (PFS) in the study was defined as the time from the date of randomization to the first occurrence of disease progression due to any cause or death, whichever occurred earlier. Secondary endpoints included overall survival, safety, time to pain progression, time to initiation of cytotoxic chemotherapy, and time to functional deterioration.

7. Hutchmed’s Fruquintinib Granted FDA Fast Track Designation for the Treatment of Metastatic Colorectal Cancer

RecentlyHutchison China MediTechannounced that the U.S. FDA has granted its targeted anticancer drugFruquintinibFast Track designation for the treatment of patients with metastatic colorectal cancer (mCRC). It is reported that Hutchmed is planning to initiate FRESCO-2, a Phase 3 registrational study of fruquintinib in patients with refractory mCRC, in the United States, Europe, and Japan. If the study yields positive results, these data, together with other relevant data, will be used to support a New Drug Application for fruquintinib as third-line treatment for mCRC in the United States.

Fruquintinib (HMPL-013) is an innovative targeted cancer therapy developed by Hutchison China MediTech. As a quinazoline-based small-molecule angiogenesis inhibitor, it primarily targets the vascular endothelial growth factor receptor (VEGFR) kinase family, including VEGFR1, VEGFR2, and VEGFR3. By inhibiting VEGFR phosphorylation on the surface of vascular endothelial cells and subsequent downstream signal transduction, fruquintinib suppresses the proliferation, migration, and tube formation of vascular endothelial cells, thereby inhibiting tumor angiogenesis and ultimately exerting an antitumor effect by restraining tumor growth.

In September 2018, fruquintinib was first approved for marketing in China under the brand name Elunate, indicated as monotherapy for patients with metastatic colorectal cancer (mCRC) who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, and who have previously received or are not suitable for anti-vascular endothelial growth factor (VEGF) therapy and anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type). It is reported that fruquintinib was included in the National Reimbursement Drug List of China last year, with sales reaching $17.6 million in 2019.

8. Assembly Biosciences Officially Launches Phase II Clinical Study of Investigational New Hepatitis B Drug ABI-H2158

A clinical-stage biopharmaceutical company dedicated to developing innovative therapies for hepatitis B virus (HBV) and microbiome-associated diseasesAssemblyBiosciencesRecently announced that the company has officially launched a more potent second-generation core inhibitorABI-H2158(2158)Phase II Clinical Trial. This international, multicenter, randomized, placebo-controlled trial will evaluate the efficacy of ABI-H2158 in combination with entecavir versus entecavir monotherapy for the treatment of HBeAg-positive, non-cirrhotic chronic hepatitis B.

In this trial, 80 patients will be randomized in a 3:1 ratio to receive either 300 mg of oral ABI-H2158 (2158) plus entecavir or placebo plus entecavir, once daily for 72 weeks. The primary endpoints include changes in HBV DNA after 24 weeks of treatment, as well as safety and tolerability throughout the study period. Secondary endpoints include changes in pgRNA and other viral antigens. Currently, initial trial sites have opened for patient screening and enrollment, and the company plans to add new research centers to the existing trial sites.

This article is sourced from EqualOcean, an original piece by author Gao Yushan. For reprinting or collaboration inquiries, please click here.Reprint Notice, Unauthorized reproduction will be subject to legal action.