Industry news

In recent years, the number of Chinese innovative drugs that have received special qualification approval from the U.S. FDA has shown a trend of increasing year by year, especially in terms of Fast Track designation. According to publicly available data, in 2024, new drugs developed by Chinese companies obtained more than 30 FDA Fast Track designations, which is a 1.5-fold increase compared to 2023. These new drugs are mostly for cancer treatment; at least 25 anti-tumor new drugs have received nearly these many Fast Track designations, covering indications such as gastric cancer, lung cancer, thyroid cancer, breast cancer and multiple myeloma among other diseases.

Fast Track designation is a special determination launched by the FDA. Its purpose is to enable drugs to be approved more quickly so as to treat serious diseases or meet unmet medical needs and benefit patients. This article will share basic information about 25 cancer new drugs that have obtained Fast Track designation in 2024, and see which patients they are expected to benefit?

On December 7, 2024, Yimufeng Biology announced that IMC002 has been granted Fast Track designation by the FDA for the treatment of patients with unresectable locally advanced, recurrent or metastatic CLDN18.2-positive gastric cancer. IMC002 is an autologous CAR-T cell therapy product targeting CLDN18.2 with nanobodies, aiming to overcome the challenges of treating solid tumors. The product is currently conducting a Phase 1 clinical trial registration for solid tumors such as pancreatic cancer and gastric cancer.

On October 30, 2024, Dongcheng Pharmaceutical announced that its subsidiary Lannacheng's product under development, 177Lu-LNC1004 injection, has been granted Fast Track designation by the FDA for the treatment of patients with metastatic iodine-131 refractory differentiated thyroid cancer who have received one or more tyrosine kinase inhibitors. The 177Lu - LNC1004 injection is a radioactive in vivo therapeutic drug targeting FAP and has currently initiated a Phase I clinical trial for solid tumors.

On October 15, 2024, Toyipharma announced that its developed CBP-1008 injection has been granted Fast Track designation by the FDA for the treatment of platinum-resistant ovarian clear cell carcinoma. CBP - 1008 is a bispecific ligand coupling drug capable of targeting both the FRa and Trpv6 receptors expressed on tumor cell membranes. The efficacy of this product for treating ovarian cancer has currently been validated.

On September 4, 2024, Xinda Biology announced that its independently developed PD-1/IL-2α bias bispecific antibody fusion protein IBI363 has been granted Fast Track designation by the FDA. The indication is for locally advanced or metastatic melanoma (excluding choroidal melanoma) that has progressed after receiving at least one line of systemic treatment with PD -1/L1 checkpoint inhibitors. IBI363 is currently in the international Phase I/II clinical trial stage targeting various advanced malignant tumors.

On August 27, 2024, BeiGene announced that the FDA has granted Fast Track designation to BGB -16673 for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously received at least two lines of therapy (including BTK inhibitors and BCL2 inhibitors). BGB -16673 is an oral targeted BTK chimera degrading activating compound (CDAC), aiming to induce the degradation of wild-type BTK and multiple mutant forms of BTK. This therapy is currently in the clinical Phase I/II development stage.

On July 15, 2024, Yuanqi Biotech announced that the FDA has granted Fast Track designation to its CAR - T cell therapy Ori - CAR -017 for the treatment of relapsed/refractory multiple myeloma. Ori -CAR-017 is a CAR-T cell therapy targeting the Gprc5d target and is currently conducting a Phase I/II clinical trial for multiple myeloma. This therapy has shown good performance in terms of antibody affinity, antigen binding activity and durability, antitumor efficacy and safety. The Phase I clinical data for multiple myeloma shows that its overall response rate reached 100%.

On July 12, 2024, Maiwei Biotech announced that its developed 9MW2821 has been granted Fast Track designation by the FDA for the treatment of locally advanced or metastatic Nectin -4 positive triple-negative breast cancer. 9MW2821 is an antibody-drug conjugate (ADC) formed by linking a humanized monoclonal antibody targeting Nectin -4 with endocytosis promoting characteristics and monomethyl auristatin E (MMAE). This is the third time in 2024 that this product has been granted Fast Track designation by the FDA. Previously, in February and May 2024, this product was successively granted Fast Track designation by the FDA for the treatment of advanced, relapsed or metastatic esophageal carcinoma; recurrent or metastatic cervical cancer which had failed after receiving platinum-based chemotherapy regimens. At present, 9MW2831 has entered Phase III clinical stage for multiple indications including cervical cancer.

On July 3, 2024, Sikangruiqi announced that its FGFR2 inhibitor 3HP - 2827 has been granted Fast Track designation by the FDA for the treatment of patients with cholangiocarcinoma harboring FGFR2 mutations. 3HP - 2827 can specifically inhibit the phosphorylation of FGFR2 with high specificity, thereby blocking the FGFR signal transduction pathway and exerting antitumor effects. This product has been approved to carry out clinical trials in China and the United States respectively, and it is planned to be used alone or in combination with chemotherapy and/or immunotherapy for tumor patients with abnormal FGFR.

On July 3, 2024, Fulian Technology announced that its PSMA - targeted radionuclide drug conjugate 225Ac - FL - 020 has been granted Fast Track designation by the FDA for the treatment of metastatic castration-resistant prostate cancer. The targeting carrier FL - 020 of this product is developed using Fulian Technology's proprietary platform, which can significantly enhance the uptake efficiency of the drug in tumor sites while ensuring rapid systemic clearance. Currently, this product is in Phase I clinical development stage.

On June 30, 2024, Hicron Pharmaceuticals announced that its protein degradation targeting chimera (PROTAC) HP518 tablet has been granted Fast Track designation by the FDA for the treatment of AR - positive triple - negative breast cancer. HP518 tablet is a highly active and selective AR protein degradation targeting chimera, which can degrade AR and its mutants and block the signal pathway of AR in triple - negative breast cancer.

On June 24, 2024, Yingen Bio and BioNTech announced that the FDA has granted Fast Track designation to DB -1311 (also known as BNT324) for the treatment of patients with advanced/unresectable or metastatic castration - resistant prostate cancer who experience disease progression during or after standard systemic therapy. DB -1311 is an innovative antibody - drug conjugate (ADC) targeting B7H3 based on topoisomerase I inhibitor, and is currently conducting a Phase I/II clinical trial for solid tumor indications.

On June 14, 2024, Xinwei announced that its newly developed Claudin18.2 - targeted next - generation ADC therapy XNW27011 has been granted Fast Track designation by the FDA for the treatment of gastric cancer. Studies have shown that XNW27011 exhibits good antitumor activity in both pharmacological models and patients with low and high expression of Claudin18.2, and has good safety and controllable overall safety.

On June 13, 2024, Xinda Biotech announced that its anti - CLDN18.2 antibody - irinotecan conjugate IBI343 has been granted Fast Track designation by the FDA for advanced pancreatic ductal adenocarcinoma with positive expression of CLDN18.2 in patients who have received at least one systemic treatment. The indications to be developed for IBI343 include gastric cancer, pancreatic cancer, bile duct cancer and other solid tumors. Among them, the clinical trial for gastric/gastroesophageal adenocarcinoma has entered phase III.

On May 21, 2024, Zhongmerica Ruikang announced that its independently developed saRNA drug RAG -01 has been granted Fast Track designation by the FDA for the treatment of non - muscle - invasive bladder cancer with Bacillus Calmette - Guerin (BCG) non - responders. RAG -01 is a double-stranded saRNA drug specifically targeting and activating the tumor suppressor gene p21, and it has obtained clinical trial authorization from the FDA for the treatment of non - muscle - invasive bladder cancer.

On April 18, 2024, Hengrui Medicine announced that its Nectin -4 targeted ADC injectable SHR - A2102 has been granted Fast Track designation by the FDA for the treatment of advanced urothelial carcinoma. SHR - A2102 is an ADC targeting Nectin -4 with a topoisomerase inhibitor (TOPi) as its payload. The clinical study of this product for advanced urothelial carcinoma has progressed to phase III stage.

On April 9, 2024, Simcere announced that its humanized GPRC5D - BCMA - CD3 trispecific antibody SIM0500 has been granted Fast Track designation by the FDA for multiple myeloma patients who have previously received at least three lines of treatment and are resistant to or unable to tolerate standard treatments known to provide clinical benefits. It is worth mentioning that Simcere reached a license cooperation of over $1.05 billion with AbbVie in early 2025 for this trispecific antibody product. Currently, this product is undergoing Phase I clinical studies in both China and the United States.

On March 28, 2024, Hengrui Medicine announced that its injectable SHR - A1921 has been granted Fast Track designation by the FDA for the treatment of platinum - resistant recurrent epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer. SHR - A1921 is a Trop -2 targeted ADC that can specifically bind to tumor cells expressing Trop -2. After being endocytosed by tumor cells, it releases small molecular toxins through lysosomal hydrolysis. This product has entered phase III clinical stage for epithelial ovarian cancer.

On March 15, 2024, Ennova Medical announced that its herpes oncolytic virus product MVR - T3011 IT (intratumoral injection) has been granted Fast Track designation by the FDA for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma who have failed prior platinum chemotherapy and PD -1/L1 therapy. MVR - T3011 is a three - in - one innovative product of herpes oncolytic virus, which has entered phase II clinical study stage for head and neck squamous cell carcinoma.

On March 11, 2024, Kolonbo Tai announced that its product under research A400 has been granted Fast Track designation by the FDA for the treatment of RET fusion-positive non - small cell lung cancer. A400 is a second - generation selective RET inhibitor with broad activity against common RET gene fusions and mutations, and has the potential to overcome drug resistance of first - generation selective RET inhibitors. In China, Kolonbo Tai is conducting a key clinical study of A400 against RET - positive non - small cell lung cancer.

On March 11, 2024, Lepu Biology announced that its tissue factor (TF) targeted ADC product MRG004A has been granted Fast Track designation by the FDA for the treatment of pancreatic cancer. MRG004A is an innovative coupling technology developed by Lepu Biology targeting differentiated targets and targeting tissue factor (TF). It connects the anti - tubulin agent MMA with high efficiency through innovative technology. The product is in phase I/II clinical study stage, and anti - tumor activity signals have been observed in indications such as pancreatic cancer, triple negative breast cancer and colorectal cancer.

On February 22, 2024, Hengrui Medicine announced that its CD79b targeted ADC injectable SHR - A1912 has been granted Fast Track designation by the FDA for the treatment of relapsed/refractory diffuse large B - cell lymphoma which has received at least two lines of prior therapy. SHR - A1912 can specifically bind to tumor cells expressing CD79b. After being endocytosed by tumor cells, it releases small molecular toxins through lysosomal hydrolysis, thereby inducing apoptosis of tumor cells. This product has entered phase II clinical stage for non - Hodgkin's B - cell lymphoma indications.

On January 31, 2024, Yingen Biology and BioNTech announced that the FDA has granted Fast Track designation to DB - 1305/BNT325 for the treatment of patients with platinum drug - resistant epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer who have previously received one to three systemic treatment regimens. This is a Trop -2 targeted topoisomerase -1 inhibitor based ADC constructed by Yingen's dedicated Dual ImmunoToxin Antibody Conjugate (DITAC) platform. The therapy is currently in phase I/II clinical trial in patients with advanced or metastatic solid tumors.

On January 23, 2024, Huajin Medicine announced that its oncolytic bacteria SalMet - Vec injection has been granted Fast Track designation by the FDA for the treatment of patients with metastatic osteosarcoma who have received at least two treatments. It is a genetically engineered biological product that carries and expresses methioninase through an attenuated Salmonella vector to play a precise targeted anti - tumor role in terms of amino acid metabolism regulation required for tumor growth. The product is in phase II clinical development stage, and the indications it plans to target cover a variety of solid tumors.

On January 8, 2024, Rongchang Biology announced that its ADC therapy RC88 under research has been granted Fast Track designation by the FDA for the treatment of patients with platinum - resistant recurrent epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer. By using the innovative bridging technology independently developed by Rongchang Biology to connect antibodies and drugs. Its structure includes mesothelial (MSLN) targeted antibody, cleavable linker and small molecular cell toxin. The product is currently in phase II clinical study stage.

On January 2, 2024, Hengrui Medicine announced that its HER3 targeted ADC injectable SHR - A2009 has been granted Fast Track designation by the FDA for the treatment of patients with metastatic non - small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations whose disease has progressed following third - generation EGFR tyrosine kinase inhibitors and platinum - based chemotherapy. SHR - A2009 consists of a fully human anti - her3 IgG1 monoclonal antibody covalently linked to a DNA topoisomerase I inhibitor via a cleavable linker. The product is currently in phase III clinical stage for advanced or metastatic non-small cell lung cancer with mutated EGFR.