Search Results for “biosimilar ” – Page 7 – media

Another GLP-1 drug king, is it on the way?

Recently, the Q3 financial reports of MNCs have been released one after another, and some are happy and some are sad. When a number of MNCs began to lower their full-year EPS, Amgen’s Q3 financial report earnings gave a high score answer sheet. Among them, Amgen’s total revenue in the third quarter increased by 23%, and its GAAP net earnings per share (EPS) increased by 62% year-on-year, from US$3.22 to US$5.22. What is more imaginative is that with the data catalysis of the new macromolecular weight loss drug AMG133, this macromolecular antibody that goes against the grain and antagonizes GIPR may become Amgen’s next gold mine. According to Amgen’s Q3 2024 financial report, the most significant year-on-year growth is LUMAKRAS (AMG510) – a targeted drug for KRASG12C mutation-positive lung cancer. The sales ceiling of this gene mutation in European and American countries will be much higher than that in Asian ...
- Source: drugdu
- 61
- November 6, 2024
Baiyu Pharmaceutical announces exclusive licensing agreement with Novartis for a small molecule anti-tumor drug

On October 17th, Baiyu Pharmaceutical announced an exclusive licensing agreement with Novartis for a small molecule anti-tumor drug. According to the agreement, Baiyu will receive a down payment of 70 million US dollars (approximately 499 million yuan), as well as various milestone payments and corresponding royalties for development, registration, and commercialization up to 1.1 billion US dollars (approximately 7.8 billion yuan). Novartis will obtain exclusive global development and commercialization rights for this small molecule innovative drug. Founded in 2005, Baiyu Pharmaceutical is headquartered in Chengdu, Sichuan. It is a global pharmaceutical enterprise with innovative drugs as its core, integrating research and development, production, sales, and traditional Chinese medicine cultivation into a full industry chain group. 10 pipelines under research, 5 tumor pipelines According to the announcement, the asset of this transaction is a small molecule innovative drug for the treatment of malignant tumors invented and discovered by the Baiyu Innovative ...
- Source: drugdu
- 67
- October 25, 2024
The second half of the battle to defend the Medicine King

Recently, Astellas announced that Japan’s MHLW has approved its ADC drug ennozumab PADCEV and Merck’s K drug as a first-line combination therapy for adult patients with fundamentally unresectable urothelial cancer. With excellent data, this combination treatment regimen was approved by the Japanese MHLW in such a short time after Merck announced on September 4 that it had been approved by the European Commission (EC) as a first-line therapy. However, sporadic victories cannot conceal the plight of K-drugs. For the pharmaceutical industry, the biggest hot spot in the past two weeks is definitely the announcement by Kangfang Biologics on September 8 that ivocilimab has become the world’s first and only single-drug head-to-head phase III clinical study to prove that its efficacy is significantly better than that of pabrolib. The drug Zizumab. On the day the results were announced, Merck’s stock price fell in response, and the dilemma was obvious. Under the ...
- Source: drugdu
- 90
- September 30, 2024
Johnson & Johnson closes two business units

On September 25, according to foreign media Endpoints, Johnson & Johnson is closing the cardiovascular and metabolic drug unit of its pharmaceutical division. This is the second large-scale reorganization since Johnson & Johnson closed its infectious disease and vaccine units. Johnson & Johnson has gradually downplayed cardiopulmonary and metabolic work since last year. Under the change, Johnson & Johnson has narrowed its research and development focus to three therapeutic areas: oncology, immunology and neuroscience. This reorganization mainly affects the commercialization work of the cardiovascular department (sales, marketing and medical affairs teams), not research and development. At present, the cardiovascular department of Johnson & Johnson’s medical device department has not been affected, and its acquisitions are still ongoing. The core product of Johnson & Johnson’s cardiovascular and metabolic drug department is Xarelto (rivaroxaban), which was once one of the world’s best-selling anticoagulants and was jointly developed by Johnson & Johnson and ...
- Source: drugdu
- 72
- September 28, 2024
Junshi Biosciences’ PD-1 Approved in the EU, Achieving Market Launch in China, the US, and Europe

As a result, Toripalimab has become the first and only PD-1 approved for the treatment of nasopharyngeal carcinoma in Europe, as well as the only first-line treatment drug for advanced or metastatic esophageal squamous cell carcinoma regardless of PD-L1 expression. Prior to this, Toripalimab had already been approved in China and the US. On July 28, Junshi Biosciences announced that Toripalimab’s marketing authorization application received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), recommending its approval for the aforementioned indications. Toripalimab injection (Chinese trade name: Tuoyi®) is the first domestically approved PD-1 monoclonal antibody in China. In December 2018, the National Medical Products Administration conditionally approved Toripalimab for the treatment of unresectable or metastatic melanoma in patients who had failed prior systemic therapy. As of now, Toripalimab has received approval for seven indications in China, covering the treatment of melanoma, nasopharyngeal carcinoma, ...
- Source: drugdu
- 106
- September 25, 2024
Wealth myth” of GLP-1

Recently, the Lasker Award, an important award in the field of biomedicine known as the “vane” of the Nobel Prize, was announced. Among them, the “Clinical Medical Research Award” was awarded to Joel Habener (Massachusetts General Hospital), Lotte Bjerre Knudsen (Novo Nordisk) ) and Svetlana Mojsov (Rockefeller University). The reason for the award is that they discovered and developed GLP-1-based drugs, which revolutionized the treatment of obesity. GLP-1, glucagon-like peptide-1, is a peptide hormone encoded by the human glucagon gene and secreted by intestinal L cells. It can promote the synthesis and secretion of insulin and suppress appetite. Delaying the emptying of gastric contents, etc. Representative products include Novo Nordisk’s semaglutide and Eli Lilly’s tilpotide. It is worth mentioning that the research on GLP-1 has not only received attention from academic awards, but also brought “vast wealth” to companies in the industrial chain due to the huge market demand. The ...
- Source: drugdu
- 95
- September 25, 2024
Leading the development of antibody drugs! Zhengda Tianqing Nanjing Shunxin Pharmaceutical was recognized as “Nanjing Engineering Research Center”

The “Nanjing Antibody Drug Screening and Transformation Engineering Research Center” built this time aims at the difficulties and pain points of key technologies and results transformation in the process of antibody drug research and development and industrialization. It will build and improve the two key platforms of “core technology breakthrough” and “innovation results transformation” to conduct independent localization research on materials and consumables required for the production of biological products, including cell culture medium, protein chromatography medium and virus removal nanofiltration membrane, and carry out results transformation and industrialization development for key innovative antibodies, antibody-drug conjugates and recombinant humanized proteins. Next, the “Nanjing Antibody Drug Screening and Transformation Engineering Research Center” will further promote the development of biological products and the joint development of upstream and downstream industrial chains, complete the transformation from biosimilars to innovative biological products, develop new antibody drugs with independent intellectual property rights, and ensure the ...
- Source: drugdu
- 126
- September 18, 2024
semaglutide is gaining ground

As we enter 2024, the global competition for “King of Medicine” is becoming increasingly fierce. In the first half of the year, Merck’s PD-1 monoclonal antibody pembrolizumab (trade name: Keytruda, “Keytruda”) successfully won the title of the world’s “king of medicine” with $14 billion. Novo Nordisk’s semaglutide (including 3 brands: Ozempic/Rybelsus/Wegovy) ranked second with sales of about $13 billion in the first half of this year, further narrowing the gap with Keytruda, and the year-on-year growth rate exceeded 40%, leaving suspense for the “king of medicine” competition in the second half of the year. On the other hand, in terms of sales growth, Eli Lilly’s tirpotide (including two brands: Mounjaro/Zepbound) grew 330% year-on-year in the first half of this year to $6.658 billion, making it the fastest-growing drug in history. Since its first indication was approved in 2022, it has grown into a super blockbuster with annual sales of over ...
- Source: drugdu
- 66
- September 5, 2024
Celltrion’s SteQeyma receives EC approval for chronic inflammatory diseases

The European Commission (EC) has approved Celltrion‘s SteQeyma (CT-P43), a biosimilar to Stelara (ustekinumab), for treating various chronic inflammatory conditions. This approval, which encompasses gastroenterology, dermatology, and rheumatology indications, follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June this year. SteQeyma, previously known as CT-P43, acts as an antagonist to human IL-12 and IL-23, addressing multiple immune-mediated diseases. It is available in subcutaneous and intravenous formulations, with the subcutaneous injection offered in 45mg/0.5ml or 90mg/1ml strengths in a single-dose, prefilled syringe. The intravenous infusion is available as a 130mg/26ml (5mg/ml) solution in a single-dose vial. Stelara, the reference product for SteQeyma, is a biologic therapy targeting interleukin (IL)-12 and IL-23 cytokines, crucial in inflammatory and immune responses. The EC’s decision is grounded on comprehensive evidence, including a Phase III trial in adults with moderate to severe plaque ...
- Source: drugdu
- 118
- August 28, 2024
FDA declines to approve Regeneron’s linvoseltamab amid manufacturing issues

The US Food and Drug Administration (FDA) has declined to approve Regeneron Pharmaceuticals’ multiple myeloma candidate linvoseltamab following an issue at a third-party manufacturing site. The complete response letter (CRL) was expected by Regeneron and disclosed in its Q2 results. The approval hold-up relates to findings from an FDA inspection of a third-party fill/finish manufacturing facility, which refers to the stage of processing that involves packaging drug products for storage and distribution. Regeneron stated that the issue was found when the agency was visiting the manufacturer as part of another company’s candidate application, and has since been resolved. An FDA re-inspection is now planned for the coming months, as per a 20 August press release. Regeneron submitted the biologics licence application (BLA) for linvoseltamab under priority review in February this year. The European Medicines Agency (EMA) is still reviewing the therapy in the same indication, and the application to the ...
- Source: drugdu
- 89
- August 23, 2024

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