The FDA approved the supplementary new drug application for Bayer's darolutamide in combination with docetaxel, which sparked widespread social attention. The news review of this week is from August 8 to 12, covering 23 pieces of information in 3 sections.
Drug Review
NMPA – Marketing
[Application]
1. On August 10, the CDE official website revealed that the marketing application for Roche's monoclonal antibody injection (Crovalimab) was accepted and included in the priority review. It is for the treatment of adults and adolescents (>=12 years old) with paroxysmal nocturnal hemoglobinuria who are not currently receiving complement inhibitor therapy. Crovalimab is expected to be Roche's first innovative drug to have China as its world debut location.
2. On August 10, the CDE official website revealed that the marketing application for the new indication of vonoprazan fumarate tablets of Takeda was accepted, which was presumed to be the eradication of Helicobacter pylori (HP) in combination with appropriate antibiotics. Vonoprazan fumarate tablets have been approved by NMPA in December 2019 for the initial treatment of reflux esophagitis and in October 2021 for the maintenance treatment of patients with recurrent reflux esophagitis.
NMPA – Clinical Trials
[Approval]
3. On August 9, Hengrui announced that its clinical trial application for HR20014 injection was approved by NMPA to treat diabetes. HR20014 injection can achieve a smooth and continuous hypoglycemic effect and control fasting blood glucose and postprandial blood glucose. Upon inquiry, no similar products from Chinese enterprises have been approved for marketing.
4. On August 10, CDE’s official website announced that an implied clinical trial license for the first-in-class drug, paltusotine tablets was granted. It was proposed to be developed for the treatment of acromegaly patients who do not respond adequately to surgery or radiation therapy, or who are not candidates for these treatments. The public information shows that paltusotine is an oral non-peptide-biased agonist (SST2 agonist).
[Application]
5. On August 9, the CDE official website revealed that the clinical trial application of Henlius’s HLX60 for the treatment of solid tumors was accepted. This is the first GARP monoclonal antibody declared for clinical use in China, which can play a therapeutic role by targeting Treg cells to inhibit the production of active TGF-β with immunosuppressive effects.
6. On August 11, the CDE official website revealed that the clinical trial application of Eli Lilly for LOXO-783 tablets was accepted. It is for the treatment of breast cancer. This is the first PI3K-αH1047X allosteric inhibitor to be declared for clinical trials in China. LOXO-783 is a PI3Kα inhibitor with high subtype selectivity that penetrates the blood-brain barrier and specifically targets the H1047R mutation (source of 15% of breast cancer cases)
7. On August 8, Bayer announced that the FDA approved the supplementary new drug application for darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide, an oral androgen receptor inhibitor (ARi) from Bayer and Orion, is currently approved in more than 60 markets worldwide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk for metastasis.
8. On August 11, Roche announced that its companion diagnostic test kit, Ventana MMR RxDx, was approved by the FDA for an expanded indication. It can be applied to identify patients with mismatch repair-deficient (dMMR) solid tumors and those with proficient mismatch repair (pMMR) endometrial cancer who can undergo the treatment with the PD-1 inhibitor, Keytruda, thereby identifying patients that are most likely to respond to a specific targeted therapy.
[Breakthrough therapy]
9. On August 8, AnHeart Therapeutics announced that the breakthrough therapy designation (BTD) for its ROS-1 inhibitor taletrectinib in development has been granted by the FDA. It is for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have not been previously treated with a ROS1 tyrosine kinase inhibitor (TKI) or have received the treatment with crizotinib.
10. On August 9, Chinagene Tech announced that its therapeutic gene editing product, ZVS203e-2 injection, was granted orphan drug designation for the treatment of retinitis pigmentosa by the FDA. Following the public information of Chinagene Tech, this is the company's 3rd gene therapeutic drug with the orphan drug designation in the field of ophthalmic genetic diseases.
11. On August 11, Impact Therapeutics announced that the FDA has granted the orphan drug designation to the fixed-dose combination capsule of senaparib and temozolomide for the treatment of adult patients with small cell lung cancer (SCLC). Senaparib is a PARP inhibitor independently developed by Impact Therapeutics, which has carried out Phase II/III clinical research on ovarian cancer, small cell lung cancer, and other indications on a global scale (China included), covering two clinical registration studies.
R&D
Clinical trials launching
12. On August 8, the Drug Clinical Trial Registration and Information Publicity Platform of CDE showed that a Phase III clinical trial for CTLA4/PD-1 bispecific antibody Candonilimab (R&D code: AK104) of Akeso, Inc. was initiated. The clinical trial is targeted for hepatocellular carcinoma. Candonilimab, a first-in-class drug developed and industrialized by Akeso, Inc., is the first core drug of PD-1/CTLA-4 bispecific tumor immunotherapy in the world.
13. On August 11, Arbele announced the successful first patient dosing in Australia for the Phase I study of CDH17xCD3 bispecific T-cell splicer, ARB202., It is for the treatment of patients with advanced gastrointestinal cancers. ARB202 is a potential "first-in-class" bispecific antibody targeting CDH17 and CD3, which is developed based on Arbele's Cadherin-17 (CDH17) target.
Clinical data release
14. On August 8, HUTCHMED announced that the pivotal global Phase III FRESCO-2 trial of fruquintinib for the exploratory treatment of advanced refractory metastatic colorectal cancer had met its primary endpoint of overall survival (OS). Fruquintinib, a highly selective and potent oral vascular endothelial growth factor receptor (VEGFR) inhibitor, was approved for marketing by NMPA in September 2018.
15. On August 8, Kodiak Sciences announced that its BEACON Phase III study of tarcocimab tedromer (KSI-301), its novel antibody biopolymer conjugate (ABC) for the treatment of macular edema secondary to retinal vein occlusion had met its primary endpoint. The results showed that the change in best-corrected visual acuity (BCVA) score in the KSI-301 group was non-inferior to that in the aflibercept group at week 24.
16. On August 8, HUTCHMED and AstraZeneca announced that preliminary results from the SAVANNAH global Phase II trial showed that Osimertinib plus Savolitinib demonstrated an objective response rate (ORR) of 49% in patients with epidermal growth factor receptor-mutated (EGFRm) NSCLC with high-level mesenchymal epithelial transition (MET) overexpression and/or amplification, whose disease progressed on treatment with Osimertinib.
17. On August 10, Innovent announced that a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study (NCT05003531) of picankibart (R&D code: IBI112) in Chinese patients with moderate-to-severe plaque psoriasis had met its primary endpoint. Picankibart is a recombinant anti-interleukin IL-23p19 subunit antibody injection self-developed by Innovent.
18. On August 10, BMS and 2seventy jointly announced that KarMMa-3, a Phase III clinical trial of their CAR-T therapy Abecma (idecabtagenevicleucel) for adult patients with relapsed or refractory multiple myeloma had met its primary endpoint. Abecma, a first-in-class chimeric antigen receptor (CAR) T-cell immunotherapy targeting BCMA, was approved for marketing by the FDA in March 2021.
Business
19. On August 8, Mersana Therapeutics announced that GSK had entered into an agreement for the co-development and commercialization of XMT-2056. XMT-2056, an immune synthesis ADC targeting HER2 neo-epitopes, is a STING-activated ADC that can activate the innate immune system through STING signaling. Preclinical data also suggest that XMT-2056 has the potential to prolong the antitumor activity through immunological memory.
20. On August 8, Hansoh Pharmaceutical Group announced that it had entered into an exclusive license agreement with TiumBio. Under the agreement, Hansoh Pharmaceutical Group will receive an exclusive license from TiumBio to develop and commercialize TU2670 in China (including Hong Kong, S.A.R., China, Macau, S.A.R., China, and Taiwan, China) for the treatment of endometriosis, uterine fibroids, and other potential indications.
21. On August 8, Pfizer and Global Blood Therapeutics announced that they had reached an agreement, under which Pfizer will pay US$68.50 for each of all outstanding shares of GBT, a total value of approximately US$5.4 billion, including the debts and net cashes acquired. GBT's lead product is Oxbryta, a drug for sickle cell disease (SCD), and with this acquisition, Pfizer will strengthen its portfolios and pipelines in SCD.
22. On August 10, MSD and Cerevance announced that they had entered a strategic research partnership to discover new targets for Alzheimer’s disease. Under the alliance, the companies will use the Nuclear Enriched Transcript Sort sequencing (NETSseq) technology platform of Cerevance to identify the targets. The technology is designed to focus on proteins that are over- or under-expressed in the diseased brain regions. At the same time, as a part of the partnership, MSD will also have access to an Alzheimer's disease program of Cerevance in the development phase.
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