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Domestic PD-1 accelerates landing in Europe and America! Junshi and Baekje are rushing to the beach, and the next one is Hengrui?

Recently, BeiGene announced that its PD-1 inhibitor Trastuzumab (US trade name: TEVIMBRA) has been officially commercialized in the United States for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received systemic chemotherapy (excluding PD-1/L1 inhibitors). Global pharmaceutical companies consider the US market as a battleground for going global. At the end of October 2023, Junshi Biotech’s trastuzumab (US trade name: LOQTORZI) obtained FDA approval, becoming the first nasopharyngeal carcinoma drug to be marketed in the United States, as well as the first biologically innovative drug and PD-1 inhibitor from China approved by the FDA. In March 2024, BeiGene’s Trastuzumab was approved for its first indication in the United States, following closely behind. After more than six months of FDA approval, Trastuzumab has finally been officially launched for sale in the United States. In the industry’s view, Chinese pharmaceutical companies such as ...
- Source: drugdu
- 68
- October 11, 2024
Another new analgesic has been submitted for marketing application

Vertex (Futai Pharmaceuticals) has a long-standing reputation. It has worked in the field of rare diseases for more than ten years and has created an orphan drug blockbuster trikafta with annual sales of over $10 billion. Today, the company has opened up new horizons in another field. Recently, Vertex announced that the FDA has accepted the marketing application of the Nav1.8 inhibitor VX-548 (Suzetrigine) and granted priority review qualification for the treatment of moderate to severe acute pain. This is a major breakthrough in the field of analgesics and may subvert the competitive landscape of analgesics commercialization. Analgesics have always been valued by the medical community, both in academia and industry. And every pharmacology textbook and medicinal chemistry textbook used as a teaching material cannot avoid a classic drug: morphine. Whether it is its rigid structure of five fused rings or its analgesic and antitussive pharmacological effects, it is well ...
- Source: drugdu
- 72
- October 11, 2024
Over $440 million! Jiahe Biologics’ new dual-antibody drug goes overseas

On August 5, Hong Kong-listed innovative pharmaceutical company Jiahe Biologics (06998.HK) announced that the group entered into a licensing agreement and equity agreement with TRC2004, Inc. on August 2. Pursuant to the License Agreement, the Group has agreed, among other things, to grant TRC2004 an exclusive global license (excluding Mainland China, Hong Kong, Macau and Taiwan) to develop, use, manufacture, commercialize and otherwise exploit GB261. According to the terms of the license agreement and equity agreement, as consideration for the license, the Group will receive a considerable amount of equity in TRC2004, an down payment of tens of millions of US dollars, milestone payments of up to US$443 million, and a single-digit to double-digit share of net sales. percentage tiered royalties. CD3/CD20 inhibitor potential stocks. GB261 is a new type of differentiated CD20/CD3 bispecific T cell engager (TCE) and the first T cell engager (T-cell Engager) that binds to CD3 ...
- Source: drugdu
- 66
- October 11, 2024
A large number of zombie approvals are facing “cleaning”?

On September 3, 2024, the Yunnan Provincial Drug Administration issued the “Notice on Further Strengthening the Supervision and Management of Drug Entrusted Production”, which clearly stated: “Applications without a drug GMP compliance inspection notice and consent to entrusted production issued by the provincial drug regulatory department where the entrusted enterprise is located will not be accepted; in principle, applications for long-term unproduced varieties that do not meet the conditions for resuming production will not be accepted.” This means that if the “zombie approval” that has not been produced for a long time is not resumed at the original factory, it will be difficult for the transferee to obtain a B certificate, that is, Yunnan enterprises basically cannot buy approvals that have not been produced for a long time. It seems that the regulatory authorities are worried about the resumption of sales of products whose generic names have not been produced ...
- Source: drugdu
- 64
- October 11, 2024
ARCH completes $3 billion fundraising! Focus on AI pharmaceuticals

ARCH Venture Partners, an American biotech investment institution, announced the completion of over $3 billion in ARCH Venture Fund XIII fundraising, aimed at supporting the establishment and development of early-stage biotech companies. The 13th fund was established following the 12th fund of $2.975 billion announced in June 2022. “After 38 years, ARCH’s investment philosophy remains the same: we bet on great science and great teams to build breakthrough companies,” said Robert Nelsen, co-founder and managing director of ARCH. “We believe that artificial intelligence and new data-driven insights into biology will help build a more preventive, curative and equitable healthcare system.” “ARCH has a long history of identifying the top forward-looking trends in life science R&D and individuals who drive truly groundbreaking scientific hypotheses,” said Keith Crandell, co-founder and managing director of ARCH. “We are very excited about the pace of innovation and efforts to understand diseases at a deeper level.” ...
- Source: drugdu
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- October 11, 2024
【EXPERT Q&A】Can metformin fight aging?

Drugdu.com expert’s response: Metformin, a widely used antidiabetic drug, has shown potential in recent research on anti-aging. Specifically, its anti-aging effects are manifested in the following aspects: Ⅰ. Scientific Research Achievements Research by the Chinese Academy of Sciences Team: After an extensive 8-year study, the team led by Liu Guanghui from the Institute of Zoology, Chinese Academy of Sciences, discovered that metformin can reset the intrinsic program of cellular aging, significantly delaying aging in primates. This achievement was published in the journal “Cell”, providing new insights into the biological mechanisms of aging and potential strategies for future interventions in human aging. Experimental Evidence: The research team conducted a 40-month follow-up study on middle-aged and elderly male crab-eating macaques. The results showed that individuals who took metformin long-term exhibited significant delays in aging, including reduced brain cortex atrophy, improved cognitive function, delayed periodontal bone degeneration, and protection of multiple tissues and ...
- Source: drugdu
- 71
- October 11, 2024
How ciprofloxacin quietly erodes vision

With the popularization of systemic drugs that may affect eye health, it is particularly important to identify the eye side effects caused by drugs. In this medical case analysis, we delved into the diagnosis and treatment process of a 55 year old male patient with toxic optic neuropathy (TON) caused by long-term use of ciprofloxacin. This case provides us with an important warning about the potential impact of drug side effects on the visual system, while also emphasizing the necessity of carefully evaluating drug use history in clinical practice. Medical history summary The patient, male, 55 years old, complained of facial recognition difficulties and decreased reading ability for more than 2 months. Upon examination, it was found that there was a decrease in symmetrical visual acuity, visual field defects, and color vision abnormalities in both eyes. He was diagnosed with TON (usually selectively affecting the optic disc macular bundle). Medical ...
- Source: drugdu
- 73
- October 10, 2024
Nearly 2 billion US dollars! What sparks can be ignited between Shiyao Group and AstraZeneca?

On October 7, 2024, Shiyao Group and AstraZeneca reached a heavyweight cooperation agreement, which caused quite a stir in the pharmaceutical industry. So, let’s explore together in what aspects the cooperation between Shiyao Group and AstraZeneca can spark. Lung cancer product Axitinib In the field of lung cancer treatment, Shiyao Group has achieved outstanding results in the treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations (EGFR ex20ins) by combining humanized EGFR monoclonal antibodies with AstraZeneca’s heavyweight product, Axitinib. The relevant research data was published in Nature Communication and has been widely recognized by the international academic community. At present, the key phase II single arm study for this indication is also being carried out smoothly, and good clinical research data has been obtained. It will be applied for market as soon as possible. Based on this good cooperation result, representatives from both parties signed a cooperation ...
- Source: drugdu
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- October 10, 2024
Investing 22.88 million yuan, leading pharmaceutical company has obtained clinical approval for nuclear drugs!

The board of directors and all directors of our company guarantee that there are no false records, misleading statements or significant omissions in the content of this announcement, and assume legal responsibility for the authenticity, accuracy and completeness of its content. Recently, Tianjin Hengrui Pharmaceutical Co., Ltd., a subsidiary of Jiangsu Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as the “Company”), received approval from the National Medical Products Administration (hereinafter referred to as the “NMPA”) to issue a “Drug Clinical Trial Approval Notice” for fluoride [18F] metoprolol injection, and will conduct clinical trials in the near future. Basic information of drugs Drug Name: Fluorine [18F] Metoprolol Injection Form: Injection Application Matters: Clinical Trial Acceptance Number: CYHL2400142 Approval Conclusion: According to the Drug Administration Law of the People’s Republic of China and relevant regulations, after examination, the Fluorine [18F] Metoprolol Injection accepted on July 9, 2024 meets the relevant requirements for ...
- Source: drugdu
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- October 10, 2024
Nearly 2 billion US dollars! What sparks can be ignited between CSPC and AstraZeneca?

Lung cancer product Axitinib In the field of lung cancer treatment, CSPC has achieved outstanding results in the treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations (EGFR ex20ins) by combining humanized EGFR monoclonal antibodies with AstraZeneca’s heavyweight product, Axitinib. The relevant research data was published in Nature Communication and has been widely recognized by the international academic community. At present, the key phase II single arm study for this indication is also being carried out smoothly, and good clinical research data has been obtained. It will be applied for market as soon as possible. Based on this good cooperation result, representatives from both parties signed a cooperation agreement in order to continue the collaboration in the Phase III confirmatory study of this indication. Chen Kangwei, General Manager of AstraZeneca China Oncology Division, stated that the strategic cooperation between the two parties is through a strong alliance ...
- Source: drugdu
- 89
- October 10, 2024

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