【Weekly Headline News】August 26~September 1, 2024 (Updated in real time~~ Chinese version also updated~~)

Carefully selected industry hot news! Synchronized push in Chinese and English!

Has your company made the list?

This series is sponsored by BioSeed Biotechnology Co., Ltd.! For promotional activities, event planning, licensing in and out, investment and financing, your needed professional services are all here!

(39) Congratulations! Adamerck’s new drug registration application has been successfully submitted (On August 30, 2024, the Class I innovative drug, a new generation of targeted muscle relaxant antagonist Adamgammadex(Aom0498), independently developed internally, has successfully completed the NDA submission to the National Medical Products Administration (NMPA) of China).

(38) 3.8888 billion yuan, two new small molecule drugs by the renowned MIT Professor Robert Langer successfully transferred! (On August 28, 2024, Bayer and NextRNA Therapeutics announced a collaboration to jointly develop two small molecule therapies targeting long non-coding RNA (lncRNA). NextRNA will receive up to $547 million (approximately 3.8888 billion yuan), including payments, milestone payments, research funding, development and commercial milestone payments, as well as tiered royalties on net sales. NextRNA was founded by well-known scientists including Robert Langer, focusing on drug development driven by lncRNA-related diseases)

(37) 2024 BioSpark Annual Conference registration is now open. Over the past few years, as a partner media outlet, Pharma Times has been fully supportive. Tomorrow morning at 9 o’clock, the latest monthly industry event review will be held in the Pharma Times live broadcast room, and all friends are welcome to watch!

(36) Mourning! Another young football player died on the field due to arrhythmia, and was pronounced dead after unsuccessful rescue efforts (On August 23, 2024, Iskierdo of the Uruguayan National Football Team collapsed on the field during the Copa Libertadores match due to arrhythmia and was pronounced dead after unsuccessful rescue efforts, at the age of only 27. He had previously been diagnosed with arrhythmia. This incident has once again drawn attention to the heart health issues of athletes, emphasizing the importance of genetic testing in preventing sudden death during sports)

(35) RigeRNA’s first Class I innovative drug RG002C0106 domestic clinical trial application officially approved (On August 30, 2024, RigeRNA Bio announced that its self-developed small interfering RNA (siRNA) Class I innovative drug “RG002C0106 injection” for the treatment of complement-related diseases has received approval from the China National Drug Administration’s Center for Drug Evaluation (CDE) for its clinical trial application (IND). Previously, on August 22, RG002C0106 was approved by the Australian Human Research Ethics Committee (HREC) to conduct Phase I clinical trial research)

(34) Keep moving forward and achieving great results | One picture to understand SinoTherapeutics’ 2024 semi-annual performance (On August 30, 2024, SinoTherapeutics released its 2024 semi-annual performance report. The company is a high-tech enterprise focusing on the research and development, innovation, industrialized production, and sales of high-end drug formulations. The company’s R&D center is located in the new drug development laboratory of the Shanghai Advanced Research Institute of the Chinese Academy of Sciences, and passed the U.S. FDA inspection in November 2016)

(33) “Nature” magazine: Table salt can activate anti-cancer immunity! Scientists have discovered for the first time that sodium chloride can enhance the anti-cancer ability of T cells | Major scientific discovery (Expert comment: This report, even the punctuation marks are not believed.)

(32) On August 30, 2024, the 2024 Novo Nordisk China R&D Day was held in Beijing, and the mother of semaglutide was present to give a speech.

(31) First case of enrollment in Phase III clinical study of Simcere’s anti-influenza innovative drug Maninosha Wei for children’s indications (Recently, the Phase III clinical trial for children’s indications of ADC189, an anti-influenza innovative drug jointly developed by Simcere Pharmaceutical and Andicon Bio, was initiated at Liuzhou People’s Hospital. ADC189 granules are the first new generation of children’s anti-influenza drugs in the country to start Phase III clinical trials, and patients can hope for a “one-dose cure”)

(30) On August 30, 2024, The launch celebration of new drug by Henlius was grandly held.

(29) Cooperation between domestic Biopharma and Biotech is booming like a spring breeze! (In September 2021, Genfleet Pharmaceutical and Innovent Biologics reached a strategic cooperation; on August 3, 2023, Investis Bio and CTTQ signed a license and cooperation agreement; in November 2023, JunShi Pharmaceutical reached a cooperation with Alist, and Alist obtained the exclusive rights to promote Gavreto in Mainland China; on August 30, 2024, Alist announced a strategic cooperation agreement with Jacobio Pharma)

(28) The first domestic KRAS G12C inhibitor was approved for marketing: The API was approved for marketing! Porton provides a full set of pharmacological research and production services for the API (On August 21, 2024, the National Medical Products Administration approved the marketing of the KRAS G12C inhibitor through the priority review process; this product is used as a monotherapy for adult patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation who have received at least one systemic treatment. Previously, it has become the first KRAS G12C inhibitor in China to receive acceptance for new drug marketing application and be included in the priority review process. At the same time, it has also obtained two domestic breakthrough therapy designations for monotherapy of advanced NSCLC and advanced colorectal cancer (CRC) patients. It is reported that this is not only the first KRAS G12C inhibitor approved in China, but also the third KRAS G12C inhibitor globally. On August 30, 2024, Porton (stock code: 300363.SZ) received the approval notice for the marketing application of the API from the National Medical Products Administration, marking the approval of this variety through the chemical raw material marketing application. Boteng provides a full set of pharmacological research and production services for the API, including IND research, clinical API supply, NDA-related research, process validation, combined dynamic inspection, and corresponding registration declaration work. In just three years, it has deeply empowered and served customers, accelerating the realization of a series of important milestone tasks from IND application to NDA acceptance, and fully promoting the approval and marketing of the API, showing Porton team’s customer-first service consciousness and efficient, professional service capabilities)

(27) Hengrui Pharma’s autoimmunity innovative drug made national first batch of shipments (On August 30, 2024, Hengrui’s self-developed Class I new drug held the first batch of shipment ceremony. Facing the bright sunshine, the cold chain vehicle full of the injection slowly left the Suzhou Shengdia production base and was officially sent to hospitals and pharmacies across the country, bringing a new treatment option for psoriasis patients. The injection was recently approved for marketing in China for the treatment of adult patients with moderate to severe plaque psoriasis suitable for systemic treatment or phototherapy. This product is the first innovative drug launched by the company in the field of autoimmune diseases, and it is also the first domestic independently developed recombinant anti-IL-17A humanized monoclonal antibody approved in China, breaking the long-term monopoly of similar imported drugs, highlighting the company’s R&D and innovation strength in the field of chronic disease innovation. Interestingly, the R&D code of this product is SHR-1314, a beautiful implication, “Guarding patients for a lifetime!”)

(26) The guest lineup for the 2024 SAPA-China Pharmaceutical Industry Conference has been updated. Dr. Guo Jinsong, the founder of DrugTimes, was invited to attend and will participate in the round table discussion session.

(25) Mabwell Bio’s Nectin-4 ADC combined with PD-1 monoclonal antibody for the first-line treatment of urothelial cancer obtained CDE agreement to carry out Phase III clinical research (Recently, Mabwell Bio announced that its submission to the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) of the “A study to evaluate the efficacy and safety of 9MW2821 combined with toripalimab versus standard chemotherapy as the first-line treatment for locally advanced or metastatic urothelial carcinoma” plan has been agreed upon, and the Phase III clinical research of 9MW2821 combined with PD-1 monoclonal antibody for the first-line treatment of urothelial cancer has been launched and is currently in the enrollment stage. 9MW2821 has been approved to carry out 3 key registration clinical studies)

(24) Genrix Bio’s Class I New Drug Selituximab Approved for Marketing (On August 27, 2024, Genrix Bio announced that its independently developed Class I new drug, Selituximab injection, has officially received the “Drug Registration Certificate” issued by the National Medical Products Administration (NMPA) and has been officially approved for marketing for the treatment of moderate to severe plaque psoriasis. Selituximab injection is the first product approved for marketing by Genrix Bio and is also the first fully human IL-17A target drug in China, breaking the monopoly of foreign-funded pharmaceutical companies in anti-IL-17A monoclonal antibodies and filling the gap in the domestic psoriasis biological preparation field, marking another step forward for China in the field of biopharmaceuticals.)

(23) 900 Million Yuan! Jacobio’s KRAS G12C and SHP2 Products Licensed to Allist (On August 30, 2024, Jacobio announced that it has licensed the rights of its KRAS G12C inhibitor Glecerisib and SHP2 inhibitor JAB-3312 in Greater China to Allist, with a total transaction amount of up to 900 million yuan. According to the agreement, Allist will pay a prepayment of 150 million yuan and other payments, as well as up to 700 million yuan in development and sales milestone payments, while Jacobio retains the global rights for these two drugs outside of Greater China. Allist’s Furmonertinib has seen rapid sales growth, with sales exceeding 2 billion yuan in 2023, and sales of 1.576 billion yuan in the first half of this year, with the full year expected to exceed 3 billion yuan. At the same time, Allist’s clinical pipeline is relatively weak, and the introduction of Jacobio’s KRAS G12C and SHP2 can quickly expand the late-stage clinical pipeline.)

(22) 547 Million USD! Bayer’s New Collaboration to Develop First-in-Class Small Molecule Therapies Targeting lncRNA (On August 28, 2024, Bayer and NextRNA Therapeutics announced a collaboration worth 547 million USD to jointly develop first-in-class small molecule therapies targeting long non-coding RNA (lncRNA). The collaboration involves two projects aimed at enhancing Bayer’s research and development pipeline in precision oncology. NextRNA focuses on treating oncology and neuroscience diseases driven by lncRNA, and its platform disrupts the interaction between lncRNA and RNA-binding proteins with small molecules.)

(21) The Misunderstanding of “First” Autoimmune Miracles (On August 27, 2024, Genrix Bio’s IL-17A monoclonal antibody drug Selituximab and Hengrui’s IL-17A monoclonal antibody drug were approved for marketing by the National Medical Products Administration on the same day, triggering a discussion about who is the “first” domestic product. This reflects the fierce competition and high expectations of domestic pharmaceutical companies in the field of IL-17A monoclonal antibodies. Secukinumab, as the global leader in this field, achieved a global sales of 2.852 billion USD in the first half of 2024, a year-on-year increase of 23%.)

(20) A major breakthrough was unexpectedly achieved by adding the wrong reagent, and Westlake University set a new record for the catalyst for electrolytic water hydrogen production! The unexpected encounter in science is so magical!

(19) Heated Debate! JAMA’s latest: The “miracle drug” for weight loss, Semaglutide, may increase the risk of suicidal or self-harming thoughts by 45%? (On August 28, 2024, JAMA Network Open published a study pointing out that Semaglutide, a GLP-1 receptor agonist used to treat type 2 diabetes, may increase the risk of suicidal or self-harming thoughts by 45%. The study is based on the World Health Organization’s individual case safety report database, analyzing the adverse drug reactions of suicidal or self-harming related to Semaglutide and Liraglutide. Despite the controversy, researchers suggest adding precautions for the use of patients with mental disorders in the instructions of Semaglutide.)

(18) 150 Million USD! Novartis and investment institutions jointly established Biotech to develop the next generation of kidney disease drugs based on xRNA (On August 22, 2024, Novartis announced the establishment of Borealis Biosciences in collaboration with the investment institution Versant Ventures. This is a discovery-stage biotechnology company located in Vancouver, Canada, developing the next generation of kidney disease drugs based on xRNA. xRNA is Novartis’s core technology platform, which can target the body’s natural mRNA to regulate the production of pathogenic proteins, thereby achieving the purpose of treatment. According to the cooperation agreement, both parties will jointly provide 150 million USD for the new company’s Series A financing. Novartis will provide up to 100 million USD in early-stage funding to Borealis, plus recent research funds. As part of the agreement, Novartis will also have the right to choose to acquire two pipeline projects at a total consideration of up to 750 million USD, including clinical and regulatory milestones.)

(17) Bo-an Bio released its performance for the first half of 2024: revenue surged by 39%, and net profit increased by 180 million yuan.

(16) uniQure’s stock price soared by 168% in two days. Why did this gene therapy company turn around? (On July 9, 2024, gene therapy company uniQure released positive clinical trial data for AMT-130 for the treatment of Huntington’s disease, causing the stock price to soar by 168% in two days. Previously, the company had laid off employees and sold part of its drug pipeline in 2023 due to financial pressure, and the stock price fell by 70.14%. The stock price turnaround this time is due to the efficacy demonstrated by AMT-130 and the optimistic sentiment of the market towards interest rate cuts.)

(15) The stock price soared by 160%, and the “King of Catheters” taught Biotech a lesson: Good technology is not as good as “selling” well (On August 27, 2024, Xiaofang Pharmaceutical went public on the main board with its catheters and other over-the-counter drugs, and the stock price soared by 167% on the first day. The company has 63 drug approvals and 7 products with the highest market share, with a market share of 17.68% for catheters in 2023. Despite the R&D investment only accounting for 3% and sales expenses less than 10%, Xiaofang Pharmaceutical’s revenue and net profit still maintained positive growth. However, its market-leading position is facing challenges from competitors, and its market share has declined.)

(14) The first batch in the world! More than 70% of patients’ tumors completely disappeared, and Regeneron’s innovative therapy has reached a milestone (On August 27, 2024, Regeneron announced that its bispecific antibody Ordspono (odronextamab) was approved by the European Commission for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). This is the first approval of odronextamab worldwide, and the clinical trial showed that more than 70% of FL patients and more than 30% of DLBCL patients had complete tumor disappearance after treatment.)

(13) Nearly 5 billion yuan! CBC Group and others jointly acquired UCB’s mature assets in China (On August 26, UCB, a global biopharmaceutical company, announced a strategic spin-off agreement in China, highlighting its strategic shift towards innovation and partnerships in one of the fastest-growing pharmaceutical markets globally. The transaction involves the sale, spin-off, and licensing of UCB’s mature businesses (neurology and allergy) in China, including Keppra®, Vimpat®, Neupro®, Zyrtec®, Xyzal®, and the manufacturing base in Zhuhai, to the CBC Group, the largest healthcare-specific asset management group in Asia, and Mubadala, an investment company headquartered in Abu Dhabi, for a price of 680 million USD (approximately 4.843 billion yuan). The drug portfolio consists of well-established and reliable solutions, continuing to provide value and reliability for patients in China.)

(12) RA Capital and Forbion have partnered to create a new autoimmune biotechnology company, introducing bispecific antibody products from a South Korean company.

(11) Legend Biotech’s Carvykti® (Ciltacabtagene Autoleucel Injection) approved for marketing in China, the 6th in the country! (On August 27, 2024, Legend Biotech (NASDAQ: LEGN) officially announced in Nanjing, China, that its independently developed cell therapy product Carvykti® (generic name: Ciltacabtagene Autoleucel Injection) has been approved by the National Medical Products Administration (NMPA) for marketing for the treatment of adult patients with relapsed or refractory multiple myeloma who have progressed after at least three lines of therapy (including at least one proteasome inhibitor and immunomodulatory agent). Carvykti® became the first product included in the breakthrough therapy program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration in August 2020. This is the 6th CAR-T therapy approved by the National Medical Products Administration following Jumei Auto-injected Cell Suspension (Fosun Kite), Reviolid® (WuXi AppTec), I-Reviloca® (Deer Bio-Pharming/Innovent Biologics), NanKi-Oleucel Auto-injected Cell Suspension (Hepalink), and Zevor-Oleucel Auto-injected Cell Suspension (Cyto-Immune/East China Pharmaceutical).

(10) GLP expected peak sales of $121 billion (According to Jeffries Research, this could mean that by 2030, sales of GLP-1 (Glucagon-like Peptide-1) in the United States will reach $10 billion, sales outside the United States (mainly the EU) will reach $20 billion, and the global peak sales will reach $121 billion)

(9) Innovent Biologics submits application to HKEX, with a post-Series B valuation of $270 million and BD transaction revenue of 2.4 billion yuan (On August 26, 2024, Innovent Biologics submitted an application to HKEX, with sponsors including Morgan Stanley, Jefferies, and CITIC Securities. Headquartered in Jiangsu, the company is a global leader in antibody-drug conjugates (ADCs) and has established cooperative relationships with multiple global partners such as BioNTech and BeiGene, with a total transaction value exceeding $4 billion. The post-Series B valuation of Innovent Biologics reached $270 million, and the company plans to use the funds raised from the listing for the research and development and commercialization of core products DB-1303 and DB-1311, as well as the development of other key products and the ADC technology platform)

(8) New risks exposed for new Alzheimer’s drug by Eisai: two patients died unfortunately (In a report on August 20, 2024, at the Alzheimer’s Association International Conference held in Philadelphia, USA, Professor Lawrence Honig, a professor of neurology at Columbia University, reported a death case of a patient treated with Eisai’s new Alzheimer’s drug Lecanemab. The patient carried two copies of the APOE4 gene, which is related to the risk of Alzheimer’s disease. Another similar death case was also mentioned at the conference, which was the first death case related to amyloid immunotherapy reported in primary care)

(7) DrugTimes welcomes friends to participate in the 2024 ChinaBio Partnering Forum! Since 2016, DrugTimes has been honored to be one of the official media partners of the ChinaBio Partnering Forum, which is a prestigious event in the pharmaceutical and biotech industries both in China and globally. Our team at DrugTimes is looking forward to discussing topics such as #drug discovery, #drug development, #business development, #partnering, #cross-border cooperation, #licensing, #M&A, #co-development, #financing, and #joint ventures with all friends at this grand event in Shanghai.

(6) Hope for long-term remission after discontinuation of medication! “Nature” journal: These autoimmune disease patients are more suitable for CAR-T therapy (A review published in “Nature Reviews Rheumatology” points out that chimeric antigen receptor T cell (CAR-T) therapy has shown the potential for long-term drug-free remission in the treatment of autoimmune diseases, especially for diseases driven by B cells, such as systemic lupus erythematosus and idiopathic inflammatory myopathy. Currently, there are 18 CAR-T therapies targeting CD19 and BCMA in the early stages of research and development)

(5) Painless drug delivery, the pen needle business of the giant Ypsomed is acquired (Medical Technology and Devices (MTD) has completed the acquisition of Ypsomed’s pen needle and blood glucose monitoring system business. Through this acquisition, MTD’s total production capacity will exceed 2.5 billion pen needles, further consolidating its position as the world’s second-largest pen needle manufacturer, and expanding into the Chinese and Indian markets)

(4) 10 Class I innovative drugs approved for clinical trials in China for the first time! (According to reports from Pharma Insight, based on the official website of the Center for Drug Evaluation of the National Medical Products Administration (CDE) and public information, 10 Class I innovative drugs were approved for clinical trials in China for the first time this week (August 19-August 25). These products include two innovative drugs targeting “synthetic lethality” targets, namely PARG inhibitors and Polθ inhibitors, as well as small molecule covalent inhibitors, small molecule allosteric inhibitors, and various drug types such as ADCs and trispecific antibodies)

(3) First of its kind! Johnson & Johnson’s breakthrough small molecule therapy approved by the EU (The European Commission has approved Johnson & Johnson’s Balversa (erdafitinib) as the first pan-FGFR kinase inhibitor for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with FGFR3 mutations)

(2) Because of the fear of death, young people have “bought” a hundred billion market (With the changing of chronic diseases, young people’s health anxiety has driven the rapid growth of the home medical device market, but the industry has problems such as uneven quality and false propaganda)

(1) The president of Innovent Biologics, Liu Yongjun, resigned and was once the highest-ranking Chinese scientist in foreign pharmaceutical companies (Liu Yongjun, the president of Innovent Biologics, resigned. He was once the highest-ranking Chinese scientist in global multinational pharmaceutical companies, responsible for the company’s global R&D and international business, etc. After his resignation, the company’s R&D system work was presided over by the founder Dr. Michael Yu)

【Disclaimer】The industry information shared on the official website of DrugTimes comes from various industry media, including DrugTimes itself, is for the convenience of readers for personal learning purposes, not for commercial profit purposes. We make every effort to list the sources of the information. All information is for the personal, cautious reference of interested professional friends. We are not responsible for the timeliness, accuracy, completeness, correctness, and other aspects of the information, data, viewpoints, nor are we responsible for any discomfort and losses caused by these information, data, viewpoints. Please be aware, dear readers. If you have any questions about the information, data, viewpoints shared here, please contact us. Our email is: contact@drugtimes.cn. We sincerely thank you for your attention, understanding, and support!