Keymed Biosciences, Inc.

CHENGDU, China, Feb. 7, 2025 /PRNewswire/ -- KeyMed Biosciences (HKEX: 02162) today announced the National Medical Products Administration (the " NMPA") of China has recently approved the supplemental New Drug Application (the " sNDA") of Stapokibart (anti-IL-4Rα monoclonal antibody, trade name: Kangyueda (康悦达), for the treatment of seasonal allergic rhinitis. The approval is based on a multi-center, randomized, double-blind, placebo-controlled phase III study to confirm the efficacy and safety of Stapokibart injection in treatment of adult patients with seasonal allergic rhinitis who are poorly controlled with nasal corticosteroids or other therapies. The study findings demonstrate that during the pollen season, in comparison with the standard treatment group, which consists of nasal spray hormones combined with antihistamine drugs, the administration of Stapokibart for two weeks effectively controls the typical nasal allergic symptoms of patients, including runny nose, nasal congestion, nasal itching, and sneezing. The least-squares mean (LSMean) of the inter-group difference is -1.3, and its 95% confidence interval (CI) is also -1.3, indicating a highly significant statistical difference (P = 0.0008). This difference far exceeds the minimal clinically important difference (MCID) of 0.23, clearly demonstrating substantial clinical benefits. Moreover, Stapokibart can effectively alleviate ocular allergic symptoms such as eye itching or burning, eye tearing or watering, and eye redness. It comprehensively enhances the quality of life of patients and exhibits excellent safety. About Stapokibart Stapokibart is a high-efficient, humanized antibody targeting the interleukin-4 receptor alpha subunit (IL-4Rα), and is the first domestically manufactured IL-4Rα antibody drug granted marketing approval by the NMPA. By targeting IL-4Rα, Stapokibart can block both interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. IL-4 and IL-13 are two key cytokines that trigger type II inflammation. Stapokibart has demonstrated good safety and encouraging efficacy in multiple previous clinical trials, and its treatment of the indication of moderate-to-severe atopic dermatitis in adults and the indication of chronic rhinosinusitis with nasal polyposis have been approved for marketing in September 2024 and December 2024, respectively. About Keymed Biosciences Keymed Biosciences Inc. (HKEX: 02162) focuses on the urgent unmet clinical needs, and is committed to providing high-quality, affordable, innovative therapies for patients in China and overseas. Keymed was founded by medical and scientific experts who have strong experience in the transformation of scientific and technological achievements to commercialization at home and abroad. SOURCE Keymed Biosciences Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Bing Yao’s ArriVent BioPharma has inked another licensing deal with a Chinese biopharma. The late-stage oncology biotech is picking up a new antibody-drug conjugate from Shanghai-based Lepu Biopharma, according to a Tuesday night disclosure. The deal — for $47 million upfront and up to a hefty $1.16 billion in biobucks — adds to a steady drumbeat of US drug developers acquiring the ex-China rights to therapies initially created or developed by Chinese biotechs. It marks at least the 11th such China-to-US biotech pact in the first three weeks of 2025, according to an Endpoints News tracker. The move is core to the operating model of ArriVent, which debuted in June 2021 with the goal of picking up drug candidates and medicines from Chinese biotechs and bringing them into the US and other geographies. The Pennsylvania biotech also has ADC collaborations with Alphamab and Aarvik Therapeutics. Lepu, meanwhile, has a joint venture with Keymed Biosciences called KYM Biosciences. AstraZeneca licensed an ADC from KYM in February 2023. Keymed has also done multiple China-to-US deals of its own in recent months. ArriVent’s pipeline is led by an oral, brain penetrant EGFR inhibitor known as furmonertinib. The medicine is approved in China, where it’s marketed by ArriVent partner Allist Pharmaceuticals. Global Phase 3 non-small cell lung cancer data are slated for this year, ArriVent said in its most recent quarterly update. With Lepu, ArriVent is staking a bet on MRG007, an experimental medicine for gastrointestinal cancers. ADCs like MRG007 are intended to target tumor cells with cytotoxic payloads and have become darlings among pharma’s oncology dealmaking teams in recent years. MRG007 will enter human trials later this year, the companies said in their announcement on Tuesday evening, or Wednesday morning in China . The move does not change ArriVent’s previously projected cash runway, which should take it “into 2026,” the biotech said. ArriVent said in November that it ended the third quarter with $282.9 million in cash and equivalents. The drug developer went public as $AVBP almost a year ago in a $175 million IPO, and it’s one of the few biotechs to have floated in the last few years that is still trading above its initial pricing. ArriVent is led by Yao, who previously took AstraZeneca spinout Viela Bio to an FDA approval for Uplizna in 2020 and then an M&A exit to Horizon Therapeutics a year later.

Today, a brief rundown of news involving Intellia Therapeutics and ArriVent BioPharma, as well as updates from Atara Biotherapeutics, Amylyx Pharmaceuticals and InnoCare Pharma that you may have missed.Gene editing specialist Intellia Therapeutics has dosed the first patient in a Phase 3 study of its in vivo CRISPR therapy for the rare disease hereditary angioedema, or HAE. The placebo-controlled study will test the efficacy of Intellias drug, dubbed NTLA-2002, in 60 adults with either Type 1 or Type 2 HAE, which can cause severe swelling attacks. The company expects to complete enrollment in the second half of this year and, pending positive results, to submit for U.S. approval in 2026. Updated follow-up data from a Phase 1/2 study will be presented this year, Intellia said Wednesday. Delilah AlvaradoArriVent BioPharma has struck a deal with Shanghai-based Lepu Biopharma Co. to gain access to an antibody-drug conjugate for gastrointestinal cancer. ArriVent, which went public one year ago, will pay $47 million to Lepu for rights outside of China, Hong Kong, Macau and Taiwan to develop and market the ADC, dubbed MRG007. Arrivent plans to soon ask for a green light to begin clinical testing in the U.S. Lepu could receive up to $1.16 billion in additional milestone payments. Delilah AlvaradoThe Food and Drug Administration has put on hold on clinical testing by Atara Biotherapeutics, including studies testing its drug Ebvallo as well as an earlier-stage CAR-T cell therapy. The hold, which halts the screening and enrollment of new patients into Ataras trials, is due to compliance issues flagged by FDA inspectors at a recent visit to a third-party manufacturing site. Those issues also led to the agencys recent rejection of Ebvallo for post-transplant lymphoproliferative disease associated with Epstein-Barr virus. Atara said its discussed remedies with the FDA and will work expeditiously to resolve the holds. Ned PagliaruloAmylyx Pharmaceuticals can move forward with a Phase 1 trial testing its experimental medicine AMX0114 for ALS after the FDA lifted a clinical hold on the study. In a statement Tuesday, Amylyx said will now work to screen, enroll and dose patients across sites in the U.S. The company, which was forced to withdraw from market an earlier ALS drug after follow-up testing showed it didnt work, plans to soon begin a Phase 1 study of AMX0114 in Canada. Early data from testing of AMX0114 could come later this year. Ned PagliaruloProlium Bioscience, a startup backed by RTW Investments, has licensed an experimental bispecific antibody from China-based developers InnoCare Pharma and KeyMed Biosciences, according to a Monday statement from the latter companies. Dubbed ICP-B02, the antibody drug binds to both CD20, a protein found on the surface of tumor cells, and CD3, an immune cell protein. Prolium will have rights to develop the drug for oncology indications in ex-Asia regions and globally for indications outside of oncology. Payments to InnoCare and KeyMed could total as much as $520 million, including an unspecified upfront fee. Ned Pagliarulo '