On September 19, the National Medical Products Administration (NMPA) released a public notice on its drug evaluation center’s official website, announcing that Lepu Biotech’s injection of Vebecotamab is proposed for priority review. This treatment is intended for patients with recurrent or metastatic nasopharyngeal carcinoma who have previously failed at least two lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapies. This drug, developed by Lepu Biotech, is an antibody-drug conjugate (ADC) targeting EGFR, with the development code MRG003. It is composed of an EGFR-targeted monoclonal antibody linked to a potent microtubule inhibitor, MMAE, through a vc linker. The molecular design of this drug has the potential to extend its application to a broader range of cancers that overexpress EGFR and may overcome various types of resistance caused by common mutations. In its previously published semi-annual report, Lepu Biotech indicated plans to submit a new drug application (NDA) for MRG003 to the ...
Original Medical Overview Medical Overview September 19, 2024 08:54 Shanghai Multiple myeloma (MM) is a blood cancer that, despite advances in treatment methods in recent years, remains an incurable disease. The traditional treatment options for MM include the combination of proteasome inhibitors (PIs), immunomodulators (IMiDs), and monoclonal antibodies (Mo Abs). Although these methods improve patient survival and progression free survival (PFS), with the emergence of treatment resistant clones, patients will eventually develop resistance to these treatments. Therefore, researchers are exploring new treatment strategies such as CAR-T cell therapy and bispecific antibodies, which activate immune T cells to kill tumor cells. Based on the review of bispecific antibodies and multiple myeloma published in the Blood Cancer Journal this month, let’s talk about the design, mechanism of action, current clinical trials, and future development directions of bispecific antibodies. 01 Bispecific antibodies and therapeutic targets Bispecific antibodies (BsAbs) are antibody constructs with two ...
Recently, Fosun Pharma (stock code: 600196.SH; 02196.HK) announced that its subsidiary, Fosun Pharma Industry, plans to invest $27 million in cash to acquire 50% of the equity of Fosun Kite held by Kite Pharma. Once this equity transfer is completed, Fosun Pharma will wholly own Fosun Kite and plans to invest an additional $10 million or its equivalent in renminbi as a capital increase for Fosun Kite. On the same day the equity transfer agreement was signed, Fosun Kite and Kite Pharma comprehensively revised and restated their original licensing agreement, signing a “Revised and Restated Licensing Agreement.” According to this agreement, Fosun Kite has obtained exclusive rights to develop, produce, and commercialize Yescarta® and Brexu-Cel (Fosun Kite’s research project FKC889) in mainland China, Hong Kong, and Macau, and within the field of cancer treatment. Additionally, Fosun Kite plans to change its name to Fosun Kairui and will function as Fosun ...
Innovative drugs are a gamble, a big gamble. Once the research and development fails, the stock price collapses and financing is unavailable. On the contrary, if the gamble is won, it is not impossible for the stock price to soar. Especially in the US stock market, it has always been so violent. For the losers, there are only two options: disband on the spot or fight back. The so-called fight back means finding a way to start the next round of innovation gambling. This requires both money and the courage to gamble. Summit is an old “gambler” who plans to gamble again. After its establishment in 2003, Summit focused on the anti-infection field, and its core product was benchmarked against vancomycin, the “last line of defense for antibiotics.” It landed on Nasdaq in 2015, but because the core product ridinilazole did not perform well in the final clinical data, the ...
In the first half of 2024, Novo Nordisk achieved revenue of 133.4 billion Danish kroner, a year-on-year increase of 24%, and its performance continued to grow. The increase in the volume of semaglutide is a key factor in the growth of performance. Ozempic, a semaglutide hypoglycemic injection, achieved revenue of 56.7 billion Danish kroner, Rybelsus, a semaglutide hypoglycemic oral agent, achieved revenue of 10.9 billion Danish kroner, and Wegovy, a semaglutide weight loss injection, achieved revenue of 21 billion Danish kroner. The total sales of semaglutide were 88.7 billion Danish kroner, a year-on-year increase of 43%, accounting for 2/3 of Novo Nordisk’s total revenue. While semaglutide is selling well around the world, Novo Nordisk is also constantly adjusting and optimizing its R&D strategy and business layout. By enriching its product portfolio, it will further strengthen its dominant position in the field of blood sugar and fat reduction. At the same ...
Looking around the world, biotech is a group with extremely high “metabolism”. According to statistics from GF Securities, since 1990, more than 600 biotech companies have IPOed on Nasdaq. However, as of June 30, 2020, only 12 biotechs have relatively stable income and positive cash flow. Extending the timeline, from the rise of the concept of biotech in the 1980s to the present, in 40 years, there are only a few who have entered the pharma camp by buying on their own. Why is it difficult for biotech to survive for a long time? This is determined by the business model. Compared with large pharmaceutical companies with average growth but strong certainty, biotech is a divergent innovation model, and the growth process is full of uncertainty. In other words, due to the high risk of R&D and the uncertainty of sales, most biotechs can’t run the business model at all, ...
Organiser:Reed Exhibitions Time:April 9th – 11th, 2025 address:3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall:Tokyo Big Sight International Exhibition Center Product range: From antibody-based medicines to nucleic acids, peptides, and other middle-molecule medicines, to gene and cellular therapies; Cutting-edge technologies in biotechnology development, including outsourced technologies and devices, among others. About bioLIVE: bioLIVE, the Japan International Biotechnology Exhibition for Life Sciences, abbreviated as the Japan Biotech Exhibition, is held annually and is Japan’s premier biotechnology exhibition. The previous edition of the exhibition was held at the Tokyo Big Sight International Exhibition Center, occupying an exhibition area of 12,000 square meters, with 268 participating companies and attracting 9,500 industry visitors.
CSPC Pharmaceutical Group has achieved significant milestones in research and development, securing conditional approval for its self-developed Class 1 new drug, Enlansub, and for the injectable version of Rayzoprazole. The company has also received approval for clinical trials in the U.S. for its antibody-drug conjugate, clinical trial approval for its mRNA vaccine against respiratory syncytial virus, and clinical trial approval for the first CAR-T cell injection based on mRNA-LNP technology. As an innovation-driven enterprise and a key player in the national industrial chain, CSPC continues to enhance its R&D investments, elevate its international influence, and fortify its product competitive edge. This year, various in-development drugs have reached key progress points, with some approved for market launch or clinical trials both domestically and internationally. Currently, CSPC is conducting over 130 innovative drug projects, with more than 50 new drugs expected to be launched in the next five years. Comprehensive Market Coverage ...
On September 6, GlaxoSmithKline (GSK) announced that its Phase 3 MATINEE study of its IL-5 antibody Nucala (mepolizumab) in the treatment of COPD achieved positive results. Compared with the placebo group, the Nucala treatment group achieved a statistically significant reduction in the annualized rate of moderate to severe exacerbations, but specific data have not yet been released. Two months ago, two COPD drugs with new mechanisms: ensifentrine and dupilumab were approved for marketing in the United States and Europe, refreshing the treatment model of this severe respiratory disease. Mepolizumab is expected to join this new round of competition. COPD: The third leading cause of death in humans Chronic obstructive pulmonary disease (COPD), referred to as COPD, is a common, preventable and treatable heterogeneous disease. According to statistics from the World Health Organization, COPD has become the third leading cause of death in humans, with about 11% of people dying from ...
Recently, a reporter from China Securities Journal visited the Shanghai Frontier Biomedical Innovation Center. Driving into the core area of the Zhangjiang Science City, a national-level biomedical base, one can see a modern, curved building from afar. Approaching closer, the open interior, visible through the yellow and white glass, creates a sense of freedom and positivity. “Currently, 10 resident companies and 11 ecological partners have signed cooperation agreements with Shanghai Frontier,” a representative from Shanghai Frontier stated. The center aims to create a “wall-less R&D center,” breaking down traditional barriers and promoting interaction and collaboration among experts, scholars, businesses, and investors from various fields and backgrounds, including industry, education, research, healthcare, and finance. Looking ahead, Shanghai Frontier will focus on cutting-edge biotechnologies such as gene and cell therapy, nucleic acid drugs, and conjugated drugs, hoping to discover and nurture highly innovative and competitive companies and projects while encouraging high-potential innovations ...
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