Xinyue Bio closes multi-million RMB Series A+ round with follow-on from XtalPi (2228.HK). This latest funding, secured within six months of XtalPi’s initial investment, underscores strong investor confidence. The funds will drive the R&D of Xinyue Bio’s “DEL+AI” platform and accelerate the clinical development of its pipeline, aiming to boost efficiency and success rates in early drug discovery. Synergy in Action: Building a New Engine for Drug R&D Xinyue Bio specializes in the advanced development and application of DNA-Encoded Library (DEL) technology, dedicated to empowering and advancing innovative drug discovery. The company’s proprietary DEL live-cell screening platform enables effective screening of membrane proteins that are difficult to express and purify. This not only expands the range of druggable targets accessible to DEL technology but also represents a screening approach that more closely mimics physiological conditions. As a pioneer in AI-driven drug discovery, XtalPi leverages a high-precision drug design platform that ...
Drugdu.com expert’s response: I. ANVISA Certification (Core Certification) The Brazilian National Health Surveillance Agency (ANVISA) is the primary regulatory authority for the export of active pharmaceutical ingredients (APIs) to Brazil. Its certification requirements include: 1. Registration Application Foreign companies must submit applications through a Brazilian-based registered agent (a qualified company or professional) responsible for document preparation, submission, and communication with ANVISA. Application documents must include: Drug composition, dosage form, dosage, pharmacological mechanism, manufacturing process, and quality management system (GMP). Clinical trial data (for new drugs) or bioequivalence study data (for generic drugs). Pharmacological and toxicological research data, stability data, etc. 2. Labeling and Packaging Insert Labels must be in Portuguese and include the drug name, ingredients, dosage form, indications, usage instructions, dosage, and adverse reactions. The packaging insert must provide detailed usage instructions, including indications, dosage, adverse reactions, contraindications, etc. 3. Review and Approval ANVISA reviews the drug’s safety, efficacy, and manufacturing compliance (GMP). ...
On January 19, AIM Vaccine (06660.HK) issued an announcement stating that its self-developed 20-valent pneumococcal polysaccharide conjugate vaccine (PCV20) has received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration (NMPA), officially granting approval for clinical trials. The vaccine is an optimized upgrade of the 13-valent pneumococcal conjugate vaccine (PCV13), adding 7 new serotypes for a total of 20 major prevalent serotypes. It is designed to prevent invasive diseases caused by these serotypes, such as pneumonia, meningitis, and bacteremia. https://finance.eastmoney.com/a/202601193623487020.html
Jiangsu Aidea Pharma Announcement: The company has received the “Drug Clinical Trial Approval Notice” approved and issued by the National Medical Products Administration (NMPA) on January 18, 2026. The notice approves clinical trials for the company’s investigational Class 2.3 modified new drug, Dolutegravir/Lamivudine/Tenofovir Tablets (ADC205), which is dedicated to the field of anti-HIV/AIDS. https://finance.eastmoney.com/a/202601193623367035.html
On January 16th, A strategic investment signing ceremony was held in Shanghai between Sifang Optoelectronics and Suzhou Changhe Biotechnology Co., Ltd. (hereinafter referred to as “Changhe Biotechnology”) . Sifang Optoelectronics acquired 57.14% of Changhe Biotechnology’s equity through a combination of capital transfer and capital increase using its own funds. This strategic integration with Changhe Biotechnology will allow the two companies to deeply integrate in areas such as product technology development, operational production, and sales channels, thereby leveraging Sifang Optoelectronics ‘ sensor technology…The company is expanding into more advanced biosafety testing instruments. Meanwhile, leveraging its expertise in core components within the sensor field, Sifang Optoelectronics will develop low-cost biosafety sensors for mass-market applications in home appliances, automobiles, and buildings. https://finance.eastmoney.com/a/202601193622798315.html
On the evening of January 19th that Mingde Biotechnology…(002932) issued an announcement stating that the company plans to acquire Lanyi (Hunan) Medical Devices in the first phase of the acquisition through capital increase and equity acquisition.The company acquired 51% equity in Hunan Lanyi Limited Company (hereinafter referred to as “Hunan Lanyi”). After the initial acquisition, Hunan Lanyi became a controlling subsidiary of the company and was included in the company’s consolidated financial statements. Through negotiation among the parties involved, the total transaction price for this capital increase and equity acquisition of 51% equity in Hunan Lanyi was RMB 35.701 million. Meanwhile, if Hunan Lanyi’s relevant operating conditions from 2026 to 2028 meet the relevant preconditions stipulated in the Acquisition Agreement, the Company will further acquire the remaining equity of Hunan Lanyi in accordance with the agreement. After the completion of the aforementioned two-stage acquisition, the Company will hold a total ...
On January 1, 2026, the new version of the National Reimbursement Drug List officially came into effect. Orelabrutinib (Yinokai®), a novel BTK inhibitor independently developed by Innovent Biologics, has rapidly achieved medical insurance coverage for first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL, commonly known as “CLL”), benefiting more patients. On January 17, during the working meeting of the Chinese Society of Clinical Oncology (CSCO) Expert Committee on Leukemia, Lymphoma and Myeloma and the 2026 CSCO Hematologic Oncology Academic Conference held in Haikou, the “Press Conference on the Implementation of Orelabrutinib 1L CLL/SLL Indication Under Medical Insurance Coverage” was successfully held. Several leading experts in the field of lymphoma gathered at the event, including Professor Ma Jun from the Harbin Institute of Hematology and Oncology, Professor Li Jianyong from Jiangsu Provincial People’s Hospital, Professor Qiu Lugui from the Institute of Hematology and Blood Diseases Hospital of the Chinese Academy ...
Lyra Therapeutics recently decided to terminate all further development of its only candidate drug for the treatment of chronic sinusitis, LYR-210 , and lay off 28 employees, retaining only the CEO and CFO as caretaker managers to find a “strategic alternative.” Just six months ago, this absorbable intranasal implant achieved positive results in a Phase 3 trial, but now it has been shelved by the company itself. LYR-210 is manufactured using Lyra’s proprietary XTreo platform : microcrystalline mometasone furoate is uniformly dispersed within a polylactic-co-glycolic acid copolymer backbone to form a 2-cm-long flexible filament. After simple implantation into the middle nasal meatus by a physician, it continuously releases glucocorticoids for up to 24 weeks, directly acting on the inflamed mucosa. Its target population is patients with chronic sinusitis (CRS) without nasal polyps. In June 2025, the pivotal Phase 3 ENLIGHTEN 2 study of LYR-210 was completed. The trial was a ...
Takeda Pharmaceuticals makes major adjustments to its US market strategy. According to recent media reports, Takeda is laying off 243 employees in the United States to cope with the market challenge of Trintellix losing its exclusive sales rights. However, Takeda also plans to hire more than 400 new positions to support the US launch and marketing of several potential new drugs. AstraZeneca continues to deepen its presence in the Chinese market. On January 16, CBMG announced an agreement with AstraZeneca, under which the latter will acquire CBMG’s 50% stake in the development and commercialization rights of C-CAR031 in China. This will grant AstraZeneca exclusive rights to develop, manufacture, and commercialize C-CAR031 globally. Under the terms of the agreement, CBMG will be entitled to receive up to $630 million from AstraZeneca, including upfront payments for the GPC3 project in China, as well as development, regulatory, and sales milestone payments. What other ...
Organiser:Informa Markets Time:April 21 -23, 2026 Address:3-21-1 Ariake, Koto-ku, Tokyo 135-0063, Japan Exhibition hall:Tokyo Big Sight International Exhibition Center Product range: From antibody medicines to medium-molecular medicines such as nucleic acids and peptides; to gene and cell medicines. Cutting-edge technologies including biopharmaceutical development outsourcing technologies and devices. About bioLIVE Japan : The bioLIVE Japan, Japan’s World Biopharmaceutical Technology Exhibition, leads the way in the development of biopharmaceutical technology in Japan. It focuses on life sciences, biotechnology, and innovative drugs, driving innovation and industrial development in the biopharmaceutical sector. Cutting-edge technologies from around the world, including biopharmaceutical development outsourcing technologies and devices, will converge at this event. The previous edition of bioLIVE Japan covered a total area of 30,000 square meters, with 712 exhibiting companies from countries such as China, South Korea, India, Thailand, Russia, the United States, and Germany, attracting 24,800 attendees. Additionally, in recent years, peptide and nucleic ...
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