Recently, the FUTURE series of studies has brought good news again. The results of the FUTURE-SUPER clinical trial led by the team of Prof. Zhimin Shao and Prof. Zhonghua Wang from the Affiliated Cancer Hospital of Fudan University have been announced, which fully confirmed the effectiveness and safety of the first-line precision treatment based on the “Fudan typing”, and is about to change the clinical practice of the treatment of TNBC. The results of the study will be announced in 2023. The results of the study were first announced at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2023, which attracted the attention of scholars around the world, and on January 9, 2024, the study was published in The Lancet Oncology, the top international oncology journal, with an impact factor as high as 51.1 under a fast-track system. The clinical study is also another landmark achievement of the ...
Review Status Hong Kong, Shanghai & Florham Park, NJ — Thursday, January 11, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) has been accepted for review and granted priority review by the China National Medical Products Administration (“NMPA”). Sovleplenib is a novel, selective, oral inhibitor targeting spleen tyrosine kinase (“Syk”), being developed for the treatment of hematological malignancies and immune diseases. The NDA is supported by data from ESLIM-01, a randomized, double-blinded, placebo-controlled Phase III trial in China of sovleplenib in 188 adult patients with primary ITP who have received at least one prior line of standard therapy. In August 2023, HUTCHMED announced that the trial had met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in durable response rate in patients treated with sovleplenib ...
COLUMBUS, Ohio, & SHANGHAI, Jan. 11, 2024 – Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, and Shanghai Henlius Biotech, Inc. (2696.HK), today announced a strategic collaboration agreement in which Henlius will receive exclusive rights to develop, manufacture and commercialize Sermonix’s lead investigational drug, lasofoxifene, in China. Under the terms of the agreement, Henlius will receive exclusive rights and sublicenses to lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in the territory, with Sermonix retaining all other global rights. Sermonix received an upfront payment and is further eligible to receive up to $58 million in certain predetermined milestones, in addition to royalties upon Henlius commercialization in China. Breast cancer is the cancer with the highest incidence rate in the world, according to GLOBOCAN 2020. There were 2.26 million new cases of breast cancer in 2020 ...
While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.” Make no mistake, given Keytruda’s size, an overall business decline will likely still hit. But Merck is focused on making “the hill to dip as small as possible and the return to growth as fast as possible,” Davis said Monday at the 2024 annual J.P. Morgan Healthcare Conference. Davis and Merck Research Laboratories President Dean Li, M.D., Ph.D., pointed to the breadth of Merck’s portfolio across oncology, infectious disease, cardiometabolic, immunology and neuroscience to explain Merck’s potential for growth. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. 2028, it’s just another year, it’s just another point. We’re focused on 2030 to 2040.” At last year’s J.P. ...
On January 9, 2024, NOVARTIS China announced that its innovative biologic Cosentyx® (stavudine) was approved by the NMPA for the treatment of adult patients with active psoriatic arthritis. This is the third indication for which Cosentyx® has been approved in China, following “moderate-to-severe plaque psoriasis” and “ankylosing spondylitis”. Psoriasis is an immune-related, chronic, relapsing, inflammatory, systemic disease. Currently, there are more than 7 million psoriasis patients in China. Psoriatic arthritis (PsA) is an inflammatory arthropathy closely related to psoriasis, with most patients experiencing joint symptoms secondary to skin lesions, and a few patients experiencing joint symptoms prior to or concurrently with skin lesions. Joint symptoms may include swelling, pain, morning stiffness and limited joint movement. Psoriatic arthritis is prone to recurrence. If not treated in time, the long-term inflammation caused by psoriatic arthritis will bring irreversible structural damage to the joints, which will seriously affect the patient’s physical function and ...
Pharmaceutical Executive Editorial Staff Rinatabart sesutecan (Rina-S; PRO1184) is under evaluation for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. The FDA has granted Fast Track designation to ProfoundBio’s rinatabart sesutecan (Rina-S; PRO1184) to treat patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer.1 The novel folate receptor alpha (FRα)–targeted antibody-drug conjugate (ADC) is comprised of an FRα-directed antibody linked to sesutecan, which is an investigational, cleavable hydrophilic linker, and the topoisomerase 1 inhibitor payload exatecan. “Our receipt of Fast Track designation from the FDA underscores our belief in the tremendous promise of Rina-S as a potential best-in-class FRα ADC to address the significant need for improved treatment options for advanced ovarian cancer,” said Naomi Hunder, chief medical officer of ProfoundBio, in a press release.1 “FRα is a highly prevalent antigen in ovarian cancer and Rina-S has shown encouraging antitumor activity and tolerability in ...
AbbVie took the top two TV drug ad spending spots with its immunology duo Rinvoq and Skyrizi, respectively, in December as it looks to cement its place as the pharma with the deepest direct-to-consumer pockets. AbbVie spent nearly identical amounts on all DTCs for each drug: $39.8 million for Rinvoq across its five spots and $39.7 million for Skyrizi across seven spots. In November, the positions of the two drugs were swapped, with Skyrizi taking the top spot and Rinvoq coming in second. Coming in third place was rival Dupixent, marketed by Sanofi and Regeneron, with a much smaller $27.6 million spent across its ads for the blockbuster med. And Pfizer has suddenly started to spend big on its new RSV vaccine Abrysvo, coming in fourth place with a strong spend of $18 million last month, more than five times the $4 million it spent in November. In fifth place ...
Recently, a phase II, non-randomized study of brain radiotherapy combined with pyrrolitinib and capecitabine for the treatment of brain metastasis in HER2-positive breast cancer (BROPTIMA study) was published online in JAMA Oncology, an authoritative international oncology journal (IF: 28.4). Prof. Guo Xiaomao and Prof. Yu Xiaoli of the Affiliated Cancer Hospital of Fudan University are the co-corresponding authors of this article, and Prof. Yang Zhaozhi and Prof. Meng Jin are the co-authors. The results of this study showed that the one-year central nervous system-progression-free survival (CNS-PFS) rate for combination therapy reached 74.9%, with a median CNS-PFS of up to 18 months and a central nervous system-objective remission rate (CNS-ORR) of 85%. In terms of safety, with a median follow-up of 17.3 months, the neurological status of most patients remained stable. This is the first prospective clinical study exploring pyrrolitinib in combination with brain radiotherapy for the treatment of patients with ...
Recently, Hengrui Pharmaceuticals’ subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the Certificate of Drug Registration approved for issuance by the State Drug Administration, approving the company’s self-developed Hengrui Pharmaceuticals Metformin Extended-Release Tablets (I) (II) (Ruicinda®) for marketing, which, together with dietary control and exercise, is applicable to adult patients with type 2 diabetes mellitus (T2DM) who are suitable for receiving treatment with Hengrui Pharmaceuticals and Metformin, in order to improve the glycemic control of such patients. This marks the successful launch of China’s first self-developed sodium-glucose cotransporter protein 2 inhibitor (SGLT2i) combined with metformin in a fixed-complex, extended-release formulation, which will bring more convenience to T2DM patients in China. Diabetes mellitus has become the third chronic disease that seriously endangers human health after tumor and cardiovascular disease. At present, China has become the first country with diabetes, in which patients with type 2 diabetes mellitus (T2DM) have a progressive decline ...
Recently, Hengrui Pharmaceuticals’ subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd. has received the Certificate of Drug Registration approved by the State Drug Administration, which authorizes the company’s self-developed Abiraterone Acetate Tablets (II) (Trademark: Eragon®) to be listed on the market. This is the first Abiraterone Acetate nanocrystalline preparation approved for marketing in China, and also the second new chemical drug of Class 2 approved for marketing by Hengrui Pharmaceuticals. Abiraterone Acetate Tablets (II) innovatively introduces nanocrystal technology, which can significantly improve drug bioavailability and reduce the degree of food influence, thus improving patients’ drug adherence, and will bring new and better therapeutic choices for metastatic prostate cancer patients in China. Prostate cancer is the most common malignant tumor of the urinary male reproductive system. In China, the incidence rate and mortality rate of prostate cancer account for the sixth and tenth of male malignant tumors, respectively. The 5-year survival rate of ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.