NMPA

Essex Bio-Technology Posts Sound 2023 Annual Financial Results, Revenue Up 29.5%, Profit Up 22.1%

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星期一, 三月 18, 2024
Cloud, Research, SKQ1, Quality control, Weather, NMPA, Therapeutic Goods Administration, Environment, Best, Intelligence, Patent, Patient, Conditional sentence, Ophthalmology, Hospital, POCT, Acquisition, CMC, European Medicines Agency, GMP, City, QMS, Bevacizumab, Chemistry, Yoy, US FDA, Traction, Good, Therapy, Point-of-care testing, VISTA, Pharmaceutical industry

The Group weathered the headwinds and managed to deliver sound performances amidst the challenging trading environment in 2023.

Key Points: 
  • The Group weathered the headwinds and managed to deliver sound performances amidst the challenging trading environment in 2023.
  • As of 31 December 2023, the Group had cash and cash equivalents of approximately HK$509.8 million (2022: approximately HK$543.5 million).
  • Together with the interim dividend of HK$0.045 per ordinary share paid on 13 September 2023, the total dividend for 2023 would be HK$0.09 (2022: HK$0.065) per ordinary share.
  • The Group's turnover is primarily made up of the ophthalmology segment ("Ophthalmology") and surgical (wound care and healing) segment ("Surgical").

HUTCHMED and Innovent Jointly Announce NDA Acceptance in China for Fruquintinib Combination with Sintilimab for the Treatment of Advanced Endometrial Cancer with Priority Review Status

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星期二, 四月 2, 2024
Toxicity, Radiation, Sintilimab, NMPA, Endometrial cancer, Disease, DCR, New Drug Application, Patient, NDA, Breakthrough therapy, Senior, Priority review, HKEX, Dor, IRC, Prognosis, PFS, Pharmaceutical industry

HONG KONG, SHANGHAI, China & FLORHAM PARK, N.J., April 02, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of fruquintinib and sintilimab for the treatment of patients with advanced endometrial cancer with pMMR1 or non-MSI-H2 tumors that have failed prior systemic therapy but are not candidates for curative surgery or radiation has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”).

Key Points: 
  • The NDA is supported by data from FRUSICA-1, the endometrial cancer registration cohort of a multi-center, open-label Phase II study investigating fruquintinib in combination with sintilimab in endometrial cancer patients who experienced disease recurrence, disease progression or intolerable toxicity with treatment on platinum-based doublet chemotherapy.
  • Data from FRUSICA-1 will be submitted for presentation at an upcoming medical conference.
  • “This is the first regulatory filing for the combination of fruquintinib and the immune checkpoint inhibitor sintilimab.
  • “Endometrial cancer remains one of the most common gynecological malignancies.

Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates

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星期五, 三月 29, 2024
CPS, Patient, Lung cancer, IND, Infection, Cancer, Investment, Cisplatin, Paclitaxel, Melanoma, Marketing, RNA, New chemical entity, Gentlemen's agreement, NRDL, Food, Therapeutic Goods Administration, Biologics license application, Insurance, Research, Junshi, National Medical Products Administration, TGA, FDA, NMPA, Tablet, COVID-19, NPC, Spacecraft, DSM-IV codes, Dacarbazine, Axitinib, Total, Pharmaceutical industry

SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.

Key Points: 
  • SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.
  • Total research and development (“R&D”) expenses were approximately RMB1,937 million in 2023, representing a decrease of approximately 19% compared to 2022.
  • Loss attributable to owners was RMB2,282 million in 2023, representing a decrease of RMB104 million compared to the previous year.
  • This application was later approved for marketing in December 2023, marking the first and only approved perioperative therapy for lung cancer domestically.

Burning Rock Reports Fourth Quarter and Full Year 2023 Financial Results

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星期四, 三月 28, 2024
Research, Fulvestrant, NMPA, AstraZeneca, Disease, Progression-free survival, CDX, Boehringer Ingelheim, Patient, Webcast, NGS, Hospital, Breast, Breakthrough, Safety, HR, Depreciation, ID, Precision, Food, Marketing, FDA, Cryptocurrency

Precision oncology diagnostics product supports advancement in late-stage breast cancer treatment, with results published in the New England Journal of Medicine in June 2023.

Key Points: 
  • Precision oncology diagnostics product supports advancement in late-stage breast cancer treatment, with results published in the New England Journal of Medicine in June 2023.
  • Total value of new contracts entered into during 2023 amounted to RMB310 million, representing a 24% increase from 2022.
  • Revenues were RMB121.1 million (US$17.1 million) for the three months ended December 31, 2023, representing a 14.9% decrease from RMB142.2 million for the same period in 2022.
  • Burning Rock will host a conference call to discuss the fourth quarter and full year 2023 financial results at 8:00 a.m. U.S. Eastern Time (8:00 p.m. Hong Kong time) on March 29, 2024.

HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

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星期四, 三月 28, 2024
OS, Savolitinib, Conference, NMPA, AstraZeneca, NSCLC, Grade 3, DCR, New Drug Application, WCLC, Patient, Neoplasm, Cerebral edema, Gamma-glutamyltransferase, MET, Lung cancer, HKEX, Dor, Safety, PFS, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the supplemental New Drug Application (“sNDA”) for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA). If approved, the new label indication for savolitinib will be expanded to include treatment-naïve patients in China.

Key Points: 
  • Savolitinib was previously granted conditional approval in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
  • Savolitinib was launched and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca for this patient population, representing the first selective MET inhibitor approved in China.
  • More than a third of the world’s lung cancer patients are in China and, among those with NSCLC globally, approximately 2-3% have tumors with MET exon 14 skipping alterations.
  • The data from this study provide confirmatory evidence for savolitinib as a targeted treatment option for treatment-naïve or previously treated patients with MET exon 14 skipping alteration NSCLC.

Inventiva reports its 2023 full-year results

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星期三, 三月 27, 2024
DSM-IV codes, NMPA, Acceleration, Partnership, Patient, Income tax, G&A, BofA Securities, MASH, Equity, SUSAR, IND, Marketing, Bank statement, IRB, Clinical trial, Investigational New Drug, European Investment Bank, Fatty liver disease, Type 2 diabetes, T2D, Euronext Paris, EIB, Phase, Optimism, NAFLD, Sino Biopharmaceutical Limited, Pharmaceutical industry

Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: “Inventiva achieved several clinical and financial milestones in 2023.

Key Points: 
  • Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: “Inventiva achieved several clinical and financial milestones in 2023.
  • R&D expenses for the fiscal year ended December 31, 2023, amounted to (€110.0) million compared to (€60.5) million in 2022.
  • Net financial income was (€5.1) million for the fiscal year ended December 31, 2023, compared to €2.8 million in 2022.
  • Income tax amounted to (€0.6) million for the 2023 fiscal year, compared to €0 million for 2022.

Santhera Announces NDA for Vamorolone in Duchenne Muscular Dystrophy Accepted and Granted Priority Review by China’s NMPA

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星期三, 三月 27, 2024
Diagnosis, NMPA, Patient, Ageing, NDA, Breakthrough, CDE, Duchenne muscular dystrophy, Therapy, Vamorolone, Safety, File, DMD, Neuromuscular disease, Pharmaceutical industry

Pratteln, Switzerland, March 27, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted by Sperogenix Therapeutics, Santhera's specialized rare disease partner for China.

Key Points: 
  • Pratteln, Switzerland, March 27, 2024 – Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted by Sperogenix Therapeutics, Santhera's specialized rare disease partner for China.
  • The Center for Drug Evaluation (CDE) of the Chinese drug authority NMPA accepted the filing and granted priority review for vamorolone in DMD for patients aged 4 years and older which could, subject to a positive outcome, lead to approval by Q1 2025.
  • Duchenne muscular dystrophy is a rare neuromuscular disease affecting about 70,000 patients in China.
  • The submission is further supported by a study which investigated the pharmacokinetic parameters of vamorolone in healthy adult Chinese volunteers.

MAIWEIJIAN, First Approved Biosimilar of Denosumab (120mg) in China

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星期一, 四月 8, 2024
NMPA, Patient, JAMA Oncology, Denosumab, Disability, RANKL, Plasma protein binding, Nephrotoxicity, National Medical Products Administration, Safety, Pharmacokinetics, Kidney, Marketing, Pharmaceutical industry

MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.

Key Points: 
  • MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.
  • Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines.
  • Doctors and patients have a high level of recognition for denosumab.
  • 3) It has a good safety profile and is not cleared by the kidney, and patients treated with denosumab experience fewer nephrotoxic side effects.

SPEVIGO® approved for expanded indications in China and the US

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星期二, 三月 19, 2024
Arthralgia, Urinary tract infection, Uncertainty, Human, NMPA, Psoriasis, Disease, Multiple organ dysfunction syndrome, Incidence, Risk, GPP, Boehringer Ingelheim, Patient, Ageing, Executive officer, Immunoglobulin G, Anxiety, Doctor of Philosophy, MD, Quality of life, Flare, Injection site reaction, Clinical trial, Skin, Fever, Immune system, Pain, Itch, Food, FDA, Yale University, Fear

In the trial with 123 patients, no flares were observed after week 4 of SPEVIGO® subcutaneous treatment in the high-dose group (n=30).13,14,15,16 In the Effisayil® 2 trial, SPEVIGO® was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus compared to placebo.

Key Points: 
  • In the trial with 123 patients, no flares were observed after week 4 of SPEVIGO® subcutaneous treatment in the high-dose group (n=30).13,14,15,16 In the Effisayil® 2 trial, SPEVIGO® was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus compared to placebo.
  • “Until now, people living with GPP have not had any approved options to treat their disease,” said Bruce Strober, MD, PhD, Clinical Professor, Dermatology, Yale University and Central Connecticut Dermatology.
  • “Experiencing GPP can be mentally and physically devastating, leaving those affected with uncertainty and fear of the next episode.
  • Therefore, expanding the treatment of GPP is a critical step towards addressing patients’ needs.”

Zai Lab Partner Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRASG12C-Mutated Locally Advanced or Metastatic...

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星期一, 四月 1, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Lung cancer, BMY, NMPA, Development, NSCLC, Cetuximab, Progression-free survival, New Drug Application, Patient, Neoplasm, Shanda, NDA, Cancer, Bristol Myers Squibb, Pancreatic cancer, CRC, Safety, PFS, FDA, PDUFA, Pharmaceutical industry

The study remains ongoing to assess the additional key secondary endpoint of overall survival.

Key Points: 
  • The study remains ongoing to assess the additional key secondary endpoint of overall survival.
  • Results of the confirmatory trial showed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients.
  • KRAZATI had no new safety signals and the safety data was consistent with the known safety profile.
  • Zai Lab thanks the patients and investigators involved in the KRYSTAL-12 clinical trial.