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【EXPERT Q&A】What are the differences between domestic generic targeted drugs and those from India?

Drugdu.com expert’s response: There are significant differences between domestically produced generic targeted drugs and Indian-produced generic targeted drugs in terms of research and development foundations, production standards, market regulation, pricing strategies, quality risks, and international recognition. A detailed analysis is as follows: I. Research and Development Foundations and Adaptability to Indications Domestically Produced Generic Drugs: These are typically developed based on extensive domestic clinical data and patient needs, enabling them to more precisely adapt to the genetic characteristics, disease spectra, and medication habits of Chinese patients. For example, domestically produced Gefitinib (Iressa) was optimized during the research and development phase to target the high-incidence mutation types in Chinese patients with non-small cell lung cancer, ensuring efficacy and safety. Indian-Produced Generic Drugs: These rely on global research and development experience, particularly excelling in the field of biosimilars. However, they may not fully consider the specific needs of Chinese patients. For instance, ...
- Source: drugdu
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- November 14, 2025
its application for marketing authorization of pertuzumab injection has been accepted.

　　On November 12, CSPC Pharmaceutical Group (01093) issued an announcement stating that the marketing application of pertuzumab injection developed by its subsidiary, CSPC Jushi Biopharmaceutical Co., Ltd., has been accepted by the National Medical Products Administration. This product is a recombinant humanized anti-HER2 monoclonal antibody injection, mainly used to treat HER2-positive breast cancer. The product has good safety and tolerability, comparable to the original reference drug. https://finance.eastmoney.com/a/202511123562408428.html
- Source: drugdu
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- November 13, 2025
The clinical trial application for BaiKe Bio-Adsorbed Cell-Free Two-Component Diphtheria-Tetanus Combined Vaccine has been approved

　　On November 12th, BaiKe Biotechnology(688276) issued an announcement stating that it recently received the “Drug Clinical Trial Approval Notice” from the National Medical Products Administration for its adsorbed acellular pertussis (two-component) diphtheria-tetanus combined vaccine (for adults and adolescents). 　　This vaccine is designed to prevent pertussis, diphtheria, and tetanus, and is intended for individuals aged 10 years and older. The approval notification number is 2025LP02992, the acceptance number is CXSL2500724, and the approval date is November 11, 2025. 　　The announcement also mentioned that there is some uncertainty regarding the conduct of subsequent clinical trials, and there is also uncertainty regarding whether commercial objectives can ultimately be achieved. 　　In the first three quarters of 2025, BaiKe Bio achieved revenue of 474 million yuan and net profit attributable to the parent company of -158 million yuan. https://finance.eastmoney.com/a/202511123562254094.html
- Source: drugdu
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- November 13, 2025
Novo Nordisk’s stock price surged after the company announced a series of major news items, withdrawing from the bidding process and receiving support from Wall Street.

　　On Tuesday (November 11), at the close of US stock trading, Novo Nordisk…U.S. stocks rose nearly 7% to $49.15. 　　Earlier today, data from the Phase II clinical trial of Novo Nordisk ‘s experimental drug coramitug (formerly known as PRX004) were presented at the American Heart Association Scientific Sessions and published in the American Heart Association journal Circulation. 　　PRX004, developed by the biotechnology company Prothena, is a novel monoclonal antibody drug designed to eliminate amyloid protein associated with the pathology of hereditary and wild-type ATTR amyloidosis (hATTR and wtATTR) without affecting the protein’s native, normal tetrameric form. In 2021, Novo Nordisk acquired the drug for $1.23 billion. 　　Phase II data presented at the conference showed that a dose of 60 mg/kg coramitug reduced N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration by 48%. (NT-proBNP is a key indicator for diagnosing ATTR-CM and assessing disease severity and prognosis.) 　　However, the lower dose of 10 ...
- Source: drugdu
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- November 13, 2025
Johnson & Johnson aims to become the “number one” company

Johnson & Johnson recently announced that the U.S. FDA has approved CAPLYTA (Lumateperone) as an adjunctive therapy in combination with an antidepressant for the treatment of major depressive disorder (MDD) in adults. This is the first new drug approved under Johnson & Johnson’s leadership since its acquisition of Intra-Cellular. 01. Major products acquired through acquisition CAPLYTA (Lumateperone) is a first-in-class small molecule drug developed by Intra-Cellular, but its origins can be traced back to Bristol-Myers Squibb (BMS). Intra-Cellular acquired the original patent for the compound from BMS in 2005 and continued to advance its research and development based on that. In January 2025, Johnson & Johnson acquired Intra-Cellular for a staggering $14.6 billion, strengthening its pipeline in the field of central nervous system (CNS) diseases. Lumateperone is a once-daily oral atypical antipsychotic. Its exact mechanism of action is not fully understood, but studies show that at therapeutic doses, it antagonizes ...
- Source: drugdu
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- November 13, 2025
HHS Removes Misleading Safety Warning Information on Menopausal Hormone Therapy Label

The U.S. Department of Health and Human Services (HHS) announced a label change for menopausal hormone therapies (MHT) or hormone replacement therapies (HRT) following an FDA request. The agency demanded the removal of broad “black box” warnings from HRT products for menopause, citing a desire to improve clarification of the benefit/risk considerations of using these medications.1 Both Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, M.D., M.P.H. announced the agency’s intentions to change the label at a press conference held at HHS.1 “Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” said Secretary Kennedy. “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their ...
- Source: drugdu
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- November 13, 2025
Global Tuberculosis Diagnoses Rise to a Record, but Deaths Fall, WHO Reports

NEW YORK (AP) — The number of people diagnosed with tuberculosis worldwide rose again last year, eclipsing 2023’s record total, World Health Organization officials said Wednesday. About 8.3 million people across the globe were reported as newly diagnosed with TB in 2024. Not all infections are diagnosed and the new numbers represent 78% of the estimated number of people who actually fell ill last year, the WHO noted. WHO officials see the increase as an indication that screening and treatment are improving after health care disruptions during the COVID-19 pandemic. Globally, the number of deaths caused by TB fell in 2024 to 1.23 million, down from 1.25 million the year before. U.S. tuberculosis cases continued to rise last year — reaching the highest level in more than a dozen years, according to preliminary data released earlier this year. The vast majority of U.S. TB cases are diagnosed in people born ...
- Source: drugdu
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- November 13, 2025
The German Dusseldorf Medical Equipment Exhibition (MEDICA)

Organiser：MEDICA Time：November 17 – November 20, 2025 Address：ostfach 10 10 06, D-40001 Dusseldorf; Stockum Church Street 61, D-40474, Dusseldorf, Germany – D-40001 Exhibition hall：Dusseldorf Exhibition Center Product range: Medical Equipment: Medical electronic instruments, clinical laboratory analysis instruments, dental equipment and materials, hemodialysis equipment, respiratory equipment, hospital ward equipment, operating room equipment, emergency room equipment, hospital office equipment, etc. Imaging and Diagnostics: Ultrasound instruments, X-ray equipment, medical optical instruments. Disposable Consumables: Disposable medical supplies, dressings and hygiene materials, various surgical instruments, etc. Medical Devices: Healthcare equipment, home healthcare products, physical therapy equipment, orthopedic technology, etc. Medical Peripherals: Information and communication technology, medical services and publications, IT systems and IT solutions, etc. Laboratory Equipment Physical Therapy/Orthopedic Technology About MEDICA German： The German Dusseldorf Medical Equipment Exhibition (MEDICA) is the world’s largest and most authoritative exhibition for hospitals and medical equipment. It holds an unparalleled position in terms of scale and ...
- Source: drugdu
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- November 13, 2025
Anke Biotech increases its investment in Boshengji and acquires exclusive national commercialization rights for its CD7-CAR-T cell therapy

　　China Securities Journal (Wang Luo) – On November 11, Anke Biotechnology…The company announced on its official WeChat account that it has signed a Capital Increase Agreement and an Exclusive Agency Framework Agreement with Boshengji Pharmaceutical Technology (Suzhou) Co., Ltd., establishing a new round of in-depth strategic cooperation. According to the agreements, Anke Biotechnology , as Boshengji’s second-largest shareholder, will invest an additional 30 million yuan to increase Boshengji’s capital. Simultaneously, Anke will leverage its commercial advantages to obtain the exclusive nationwide distribution rights for Boshengji’s core product, PA3-17 injection. This move marks a formal upgrade from early R&D cooperation and equity investment to a comprehensive strategic partnership based on “capital binding and joint business operation.” 　　This collaboration revolves around Boshengji’s core investigational product—PA3-17 injection, the world’s first Investigational New Drug (IND) approved product targeting CD7 autologous CAR-T cells. Developed independently by Boshengji Anke Cell Technology Co., Ltd., a wholly-owned subsidiary ...
- Source: drugdu
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- November 12, 2025
Zhifei Biological’s subsidiary receives approval for clinical trials of its DPT vaccine for adolescents and adults

　　On November 11, Zhifei Biological Products Co., Ltd.(300122) issued an announcement stating that the company recently received approval from the National Medical Products Administration to allow its wholly-owned subsidiary to conduct clinical trials of its adsorbed acellular pertussis-diphtheria-tetanus (diphtheria-tetanus) combined vaccine (for adults and adolescents). 　　This vaccine aims to prevent infectious diseases such as diphtheria, tetanus, and pertussis, filling the market gap in domestic DPT (diphtheria, pertussis, and tetanus) vaccines for adolescents and adults. This approval marks a significant advancement for the company in vaccine development; the adolescent and adult DPT vaccine is a new generation of acellular vaccine, using separately purified active ingredients. 　　The company stated that if the clinical trials proceed smoothly, it will further enhance its market competitiveness, enrich its product line, and lay the foundation for long-term development. While this approval will not have a significant impact on near-term performance, future product development progress will improve ...
- Source: drugdu
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- November 12, 2025

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