NRDL

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

Retrieved on: 
Friday, March 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.

China Medical System （867.HK）2023 Annual Results: Despite of the Temporary Financial Performance Pressure Fresh Catalysts Emerged from Successive Innovation Breakthroughs

Retrieved on: 
Thursday, March 28, 2024
Sclerotherapy, RMB, Conditional sentence, NDA, IND, Creativity, Small RNA, Marketing, Gastroenterology, Central nervous system, FIC, City, BIC, CMS, NRDL, Injection, Dermatology, CDMO, Commercialization, Tablet, Pharmacy, Methotrexate, Hospital, Acquisition, Gonadotropin-releasing hormone, RCT, VBP, Rheumatoid arthritis, Growth, Varicose veins, Ecosystem, Blue, Government, Ophthalmology

SHENZHEN, CHINA, March 27, 2024 (GLOBE NEWSWIRE) -- On March 27, 2024, China Medical System (“CMS” or the “Company”) released its 2023 annual results.

Key Points: 
  • SHENZHEN, CHINA, March 27, 2024 (GLOBE NEWSWIRE) -- On March 27, 2024, China Medical System (“CMS” or the “Company”) released its 2023 annual results.
  • Based on above, CMS has successfully entered into its “New Period” of innovation and internationalization development.
  • 4 innovative drugs have started large-scale clinical application, unveiling CMS’s first year of commercialization era of innovative drugs.
  • Under its compliant and efficient commercialization system, the Company's innovative products and exclusive drugs will grow steadily.

InnoCare Releases 2023 Results and Business Highlights

Retrieved on: 
Thursday, March 28, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, QD, Tafasitamab, Patient, B-cell lymphoma, NDA, SLE, POC, IND, Clinical trial, Bone marrow, IKZF1, Phase, Therapy, IGA, MCD, Dexamethasone, MCL, Neuromyelitis optica spectrum disorder, IKZF3, AML, NMOSD, Outline of health sciences, DLT, Cancer, Autoimmune disease, Safety, TYK2, HSA, NRDL, BLA, Follicular lymphoma, Food, GC, Development, Multiple sclerosis, PD, CRBN, Public, Gordon Ramsay's Bank Balance, Multiple myeloma, ITP, BCL2, Leukemia, Cmax, Gadolinium, HKEX, SRI, AAD, Proteinuria, DLBCL, Glucocorticoid, IVIG, Loss, European Hematology Association, American Academy, EHA, Lenalidomide, NHL, Non-Hodgkin lymphoma, CCR8, US FDA, BTK, NRS, Pharmaceutical industry

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, today announced the 2023 annual results as of 31 December 2023.
  • In 2023, InnoCare has continued to advance its robust pipeline across various clinical stages, continuously unleashing the power of innovation to meet unmet medical needs.
  • In June 2023, the ITP Phase II result was orally presented at the European Hematology Association (EHA) 2023 Hybrid Congress.
  • InnoCare was approved by the Hong Kong Stock Exchange to remove "B" from the stock code from May 12, 2023.

InnoCare Announces Approval of Clinical Trial of BCL2 Inhibitor ICP-248 in Combination with Orelabrutinib as First-Line Therapy for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China

Retrieved on: 
Wednesday, March 13, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, SLL, CLL, Hematology, E-3, Incidence, Patient, Malignancy, BCL2, Cancer, Leukemia, Death, IND, Clinical trial, Investigational New Drug, HKEX, BTK, Safety, Marketing, NRDL, Lymphoma, CD19, Pharmaceutical industry

This multicenter, randomized-controlled, open-label clinical study is designed to evaluate the efficacy and safety of ICP-248 combined with orelabrutinib versus immunochemotherapy in treatment-naive patients with CLL/SLL.

Key Points: 
  • This multicenter, randomized-controlled, open-label clinical study is designed to evaluate the efficacy and safety of ICP-248 combined with orelabrutinib versus immunochemotherapy in treatment-naive patients with CLL/SLL.
  • ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which aims to treat hematologic malignancies as a monotherapy or in combination with other therapies.
  • BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies.
  • ICP-248 has an anti-tumor effect by selectively inhibiting BCL2 and restoring the mechanism of programmed cell death.

HUTCHMED Reports 2023 Full Year Results and Provides Business Updates

Retrieved on: 
Wednesday, February 28, 2024
Neoplasm, RMB, SHPL, Net, EZH2, Growth, FC, Tax, Follicular lymphoma, FX, Fast Track, TCFD, Ethics, Marketing, RCC, Health, CER, Sintilimab, ITP, Disclosure, Plasma protein binding, Lancet, MET, Completeness, D-19, Paclitaxel, Met, NDA, NSCLC, EGFR, NRDL, Atopic dermatitis, ESG, CRC, PD-1, Completion, Phases of clinical research, Task force, Half-life, Chills, Potential, Breakthrough therapy, NMPA, Investment, FGFR, Research, PFS, AstraZeneca, EMA, ADS, Annual report, ASCO, FDA, Carbon accounting, VEGFR, Lung, COVID-19, Alopecia areata, PMDA, Lilly, Patient, Cancer, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical company, today reports its financial results for the year ended December 31, 2023 and provides updates on key clinical and commercial developments. HUTCHMED to host results call and webcasts today at 7:30 a.m. EST / 12:30 p.m. GMT / 8:30 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, February 29, 2024.

Key Points: 
  • HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders.
  • The 2023 Sustainability Report will be published alongside our 2023 Annual Report in April 2024 and will include further information on HUTCHMED sustainability initiatives and their performance.
  • Net Income attributable to HUTCHMED for 2023 was $100.8 million compared to Net Loss attributable to HUTCHMED of $360.8 million in 2022.
  • The net income attributable to HUTCHMED in 2023 was $0.12 per ordinary share / $0.59 per ADS49, compared to net loss attributable to HUTCHMED of $0.43 per ordinary share / $2.13 per ADS in 2022.

Global Times: How two sessions serve as bridge between people and government, help authorities formulate policies

Retrieved on: 
Friday, March 8, 2024
CCTV, China National Radio, Motion, The, Student, NRDL, National Medical Products Administration, Education, News, Party school, Hospital, Pediatrics, Peking University, Sun Jie, Dermatology, Parent, Catalog, World Health Organization, Global Times, Hope, CPPCC, University, SMA, Prevalence, Hematology, Sun, CPC, NPC, Patient, Policy, Real-time, Disease, Diagnosis, Child, National Committee, Economics, WeChat, Research, Insurance, Pharmaceutical industry

Various localities in the country are implementing policies on medication, health insurance and research according to the catalog.

Key Points: 
  • Various localities in the country are implementing policies on medication, health insurance and research according to the catalog.
  • In 2021, China also for the first time included a rare disease treatment in its National Reimbursement Drug List.
  • These moves together benefited thousands of Chinese suffering from rare diseases, including spinal muscular atrophy (SMA) patient Zhang Jianuo and his parents.
  • Motions and proposals during the two sessions are crucial pathways for addressing issues impacting people's livelihood, and they're becoming increasingly effective.

argenx Highlights 2024 Strategic Priorities

Retrieved on: 
Monday, January 8, 2024
Immunoglobulin therapy, GMG, FDA, PRV, Congenital myasthenic syndrome, ARDA, Research Councils UK, Euronext, Inflammation, Cohort, PGIC, NRDL, Autoimmunity, Efgartigimod alfa, Dermatomyositis, Conference, MuSK protein, IND, CIDP, Pharmacokinetics, MMN, Safety, Therapy, Patient, ALS, Immune system, IL-6, Medicine, International Myeloma Foundation, IIP, FSS, Neonatal Fc receptor, Multifocal motor neuropathy, Growth, Pharmaceutical industry

argenx is planning to reach more patients commercially in 2024 through its multi-dimensional expansion efforts.

Key Points: 
  • argenx is planning to reach more patients commercially in 2024 through its multi-dimensional expansion efforts.
  • In addition, ARGX-119, a muscle-specific kinase (MuSK) agonist, will initiate Phase 1b/2a studies in congenital myasthenic syndrome and amyotrophic lateral sclerosis in 2024.
  • As of December 31, 2023, argenx had approximately $3.2 billion in cash, cash equivalents and current financial assets*.
  • Based on its current operating plans, argenx expects its combined R&D and SG&A expenses in 2024 to be less than $2 billion.

Paratek Pharmaceuticals Announces Inclusion of Oral NUZYRA® in China’s National Reimbursement Drug List

Retrieved on: 
Wednesday, December 13, 2023
Food, ABSSSI, Bronchopneumonia, NMPA, Public, NRDL, Patient, Safety, CABP, Pharmaceutical industry

Earlier this year, NHSA added the intravenous (IV) formulation of NUZYRA to the NRDL for the treatment of CABP and ABSSSI.

Key Points: 
  • Earlier this year, NHSA added the intravenous (IV) formulation of NUZYRA to the NRDL for the treatment of CABP and ABSSSI.
  • “The addition of oral NUZYRA to China’s NRDL allows millions of patients increased accessibility, at reduced prices, to the once-daily oral and IV formulations of this life-saving therapy for serious community-acquired infections,” said Evan Loh, M.D., Paratek chief executive officer.
  • “This inclusion further expands China’s antibiotic armamentarium to address antimicrobial resistance, an ever-growing, urgent, global public health crisis.
  • Paratek’s partner in China, Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688), received approval of both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration (NMPA) of China for the treatment of CABP and ABSSSI in December 2021.

HUTCHMED Announces Continued Inclusion of ELUNATE® (fruquintinib) and SULANDA® (surufatinib) in the National Reimbursement Drug List in China at Current Terms

Retrieved on: 
Wednesday, December 13, 2023
CRC, NET, HKEX, Incidence, Cancer, NRDL, Patient, Senior

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Dec. 13, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM, HKEX:​13) today announces that under the 2023 simple renewal mechanism of the China National Healthcare Security Administration (“NHSA”), on January 1, 2024 the updated National Reimbursement Drug List (“NRDL”) will continue to include ELUNATE® (fruquintinib) and SULANDA® (surufatinib) at the same terms as the current two-year agreement.

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Dec. 13, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:​HCM, HKEX:​13) today announces that under the 2023 simple renewal mechanism of the China National Healthcare Security Administration (“NHSA”), on January 1, 2024 the updated National Reimbursement Drug List (“NRDL”) will continue to include ELUNATE® (fruquintinib) and SULANDA® (surufatinib) at the same terms as the current two-year agreement.
  • Mr Hong Chen, Senior Vice President and Chief Commercial Officer (China) of HUTCHMED, said: “The NRDL has made it possible for our innovative medicines to quickly reach more patients in need across China.
  • In the past few years, we have seen an array of new measures adopted by the NHSA, including the NRDL negotiation, the bidding process for non-exclusive medicines and simplified renewal rules for already listed medicines.
  • In China, there were an estimated 71,300 newly diagnosed NET patients in 2020, with potentially up to 300,000 patients living with the disease.2

China’s 2022 NRDL Update Demonstrates Promising Pricing and Access Opportunities for Innovative Drugs With Significant Clinical Benefit

Retrieved on: 
Wednesday, December 20, 2023
Oncology, Health, Infectious Diseases, Other Health, Health Insurance, General Health, Pharmaceutical, NRDL, Publication, Photograph, Access, Trinity, Chronic condition, Multimedia, Doctor of Philosophy, Pharmaceutical industry

Trinity Life Sciences, a leader in global life sciences commercialization solutions, reports that China’s 2022 National Reimbursement Drug List (NRDL) demonstrates promising pricing and access opportunities for innovative drugs with significant clinical benefit.

Key Points: 
  • Trinity Life Sciences, a leader in global life sciences commercialization solutions, reports that China’s 2022 National Reimbursement Drug List (NRDL) demonstrates promising pricing and access opportunities for innovative drugs with significant clinical benefit.
  • The new white paper “2022 NRDL Pricing Implementation and Access Outcomes in China” provides an in-depth analysis and key takeaways of the update.
  • View the full release here: https://www.businesswire.com/news/home/20231220191192/en/
    Cover image from Trinity Life Sciences' white paper, "2022 NRDL Pricing Implementation and Access Outcomes in China."
  • An on-demand webinar, “2022 NRDL Pricing Implications and Access Outcomes” explores the latest pricing dynamics from the 2022 NRDL update that manufacturers should learn to succeed in China market access.