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Eli Lilly’s new acquisition

Lilly recently announced a definitive agreement to acquire biotechnology company Merida Biosciences for up to $2.875 billion. The transaction includes upfront payments and potential milestone payments and is expected to close in the fourth quarter of 2026. Founded in 2022 and headquartered in the United States, Merida Biosciences completed a $121 million Series A funding round in 2025. The company is developing engineered biologics with a specific antigen at one end of its molecular structure that binds to pathogenic antibodies, and an engineered Fc fragment at the other end that mediates endocytosis and degradation by hepatocytes, thereby selectively clearing pathogenic autoantibodies while preserving normal immune function. This mechanism targets antibody-driven autoimmune diseases and allergic diseases. Merida’s first pipeline product, MER511, is currently in Phase I clinical trials for the treatment of Graves’ disease and thyroid eye disease. Graves’ disease is an autoimmune thyroid disorder affecting approximately 3 million people in ...
- Source: drugdu
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- September 2, 2026
World’s First Oral IL-23R Peptide Drug! Janssen’s Icotrokinra (艾特雅®) Approved in China for Psoriasis | Approval Alert

On August 27, 2026, Johnson & Johnson announced that its interleukin-23 (IL-23) receptor antagonist icotrokinra (艾特雅®, 盐酸伊可白滞素片) has been officially approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, as well as pediatric patients aged 12 years and older weighing at least 40 kg. Icotrokinra is the first and currently only targeted oral peptide drug that precisely blocks the IL-23 receptor. The Center for Drug Evaluation of the NMPA granted it priority review qualification in November 2025. In four Phase III clinical studies enrolling a total of 2,500 patients, icotrokinra met all primary efficacy endpoints and demonstrated a favorable safety profile. In the head-to-head superiority study, approximately 70% of patients achieved complete or almost complete skin clearance (IGA 0/1) at Week 16, and 55% achieved a Psoriasis Area and Severity Index improvement of ...
- Source: drugdu
- 40
- September 2, 2026
First Domestic FGFR1/2/3 Inhibitor! HUTCHMED’s ATLED® (Fanregratinib) Receives Conditional NMPA Approval | Approval Alert

On August 28, 2026, HUTCHMED (China) Limited (Nasdaq/AIM: HCM; HKEX: 13) announced that the New Drug Application (NDA) for fanregratinib (HMPL-453) has been granted conditional approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma (ICC) harboring FGFR2 fusions or rearrangements who have received prior systemic therapy. Fanregratinib will be marketed in China under the brand name ATLED®. Intrahepatic cholangiocarcinoma is a highly aggressive malignancy originating from the intrahepatic bile duct epithelium, accounting for approximately 8.2%-15.0% of primary liver cancers and ranking as the second most common type of liver cancer after hepatocellular carcinoma. In recent years, the incidence of intrahepatic cholangiocarcinoma has been continuously rising, with a 5-year overall survival rate of approximately 9%. Approximately 10%-15% of intrahepatic cholangiocarcinoma patients worldwide harbor FGFR2 fusions or rearrangements. This approval is supported by data from the Phase II registration cohort ...
- Source: drugdu
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- September 2, 2026
Simcere Zaiming Signs Exclusive Licensing Agreement with Roche for Global Development of Tri-Specific Antibody SIM0660 | Partnership News

On September 1, 2026, Simcere Zaiming, the anti-tumor innovative drug subsidiary of Simcere Pharmaceutical Group (02096), announced that it has signed an exclusive licensing agreement with Roche for the global development and commercialization of SIM0660, a CD79a/CD19/CD3 tri-specific antibody with therapeutic potential for multiple B-cell-related diseases. Under the terms of the agreement, Roche will receive exclusive worldwide rights for the development, manufacturing, and commercialization of SIM0660. Simcere Zaiming will be eligible to receive total transaction payments of up to $1.53 billion, including a $75 million upfront payment. Based on future net sales, Simcere Zaiming may also be entitled to tiered double-digit royalties. SIM0660 is a tri-specific antibody developed using Simcere Zaiming’s T-cell engager (TCE) multi-specific antibody technology platform. The molecule fuses a CD3-binding T-cell engager arm with binding domains targeting two B-cell antigens, CD79a and CD19, inducing potent T-cell-mediated cytotoxicity while effectively limiting cytokine release. This dual-target strategy has potential ...
- Source: drugdu
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- September 2, 2026
FDA Approves First RAS-Targeted Therapy Rasonque for Pancreatic Cancer, Nearly Doubling Survival | Industry News

On August 26, the U.S. Food and Drug Administration (FDA) approved daraxonrasib for the treatment of pancreatic ductal adenocarcinoma (PDAC), the most common type of pancreatic cancer in adults. The approval covers patients whose cancer has metastasized to other parts of the body and for whom other treatments have failed. The drug is marketed by Revolution Medicines under the brand name Rasonque. Daraxonrasib is the first targeted therapy approved specifically for pancreatic ductal adenocarcinoma. It inhibits a protein called RAS, which acts like a molecular switch that can become stuck in the “on” position, driving cancer cell growth. Daraxonrasib disables this molecular switch, thereby inhibiting cancer cell growth. More than 90% of pancreatic ductal adenocarcinoma patients carry gene mutations that keep the RAS protein in the “on” state, leading physicians to expect the drug to benefit many patients. The FDA based its approval on clinical trial results presented at the ...
- Source: drugdu
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- September 2, 2026
【EXPERT Q&A】Is ce certification required for products exported to the European Union?

Drugdu.com expert’s response: Products exported to the EU ‌do not all require CE marking‌. Only product categories explicitly covered by the EU’s unified harmonised regulations are mandatorily required to affix the CE mark. Products outside the scope of the regulations do not need to apply for CE certification, nor may they use the CE mark arbitrarily. Mandatory Application Areas for CE Certification ‌Core regions‌: All EU member states, plus Iceland, Liechtenstein and Norway (the three EEA countries), where CE marking is a legal market access requirement. ‌Other recognized regions‌: Turkey also recognizes CE certification as a basis for market access, subject to confirmation in accordance with the latest local regulations. ‌Special note‌: After Brexit, the UK no longer fully recognizes the CE mark on its domestic market, and the UKCA marking requirements shall apply instead. Common Product Categories Mandatorily Requiring CE Certification ‌Electrical and electronic products‌: Household appliances, lighting equipment, ...
- Source: drugdu
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- September 2, 2026
Pharmaconex

Organiser：Informa Markets Time：September 1st – 3rd, 2026 Address：El-Nasr Rd Al Estad Nasr City Cairo Governorate Exhibition hall：Cairo International Convention Centre Product range: Vitamins, hormones, antipyretic analgesics, digestive system drugs, anti-infective drugs, antiparasitic drugs, cardiovascular system drugs, pharmaceutical intermediates Pharmaceutical packaging materials, PVC/PVDC composite sheets, PVC rigid sheets, PS sheets, packaging anti-counterfeiting technology information, labeling and sleeving technologies, labeling machines, packaging containers, form-fill-seal machines, wrapping machines, paper-based film packaging machinery, bag packaging machines, etc. Infusion equipment production lines, dryers, water treatment equipment, refrigeration compressors, distillation equipment, sterilization equipment, tablet presses, coating machines About Pharmaconex： The Pharmaconex – Egypt Cairo Pharmaceutical Raw Materials Exhibition is the most renowned exhibition focused on pharmaceutical raw materials and technologies in Egypt. It is hosted by Informa Markets, a world-famous British exhibition organizer with rich experience and strong capabilities in exhibition organization, and it holds great significance for enterprises looking to explore the Egyptian ...
- Source: drugdu
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- September 1, 2026
Baoji Pharmaceutical’s HER2 bispecific antibody KJ015 received FDA approval in the United States, marking a key step in its internationalization strategy.

[Shanghai, China] Shanghai Baoji Pharmaceutical Co., Ltd. (hereinafter referred to as “Baoji Pharmaceutical”) recently announced that its Investigational New Drug (IND) application for KJ015, a subcutaneous formulation of a HER2-targeting bispecific antibody, was officially approved by the U.S. Food and Drug Administration (FDA) on August 21, 2026, authorizing it to conduct clinical trials in the United States. This is another significant milestone for KJ015, following its IND approval from the China National Medical Products Administration (NMPA) in December 2024 and the initiation of Phase I clinical trials in China in June 2025 . Powered by universal light chain technology: An antibody achieves dual blockade with Herceptin and Perjeta. KJ015 is an innovative subcutaneous formulation of a bispecific anti-HER2 antibody derived from universal light chain technology. It is designed with two Fab arms containing universal light chains, forming a near-native IgG1 structure. By maintaining high affinity for both epitopes simultaneously, KJ015 ...
- Source: drugdu
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- August 31, 2026
Takeda’s first-ever innovative drug approved for market launch

On August 28, Takeda announced that Rusfertide (trade name: Mimrylo) has been approved by the FDA for the treatment of adult patients with polycythemia vera (PV). Rusfertide is a first-in-class hepcidin analogue , acquired by Takeda from Protector Therapeutics . It is designed to regulate iron distribution and excessive erythrocyte production in the body to control hematocrit (the ratio of red blood cells to total blood volume). The primary treatment goal for PV is to keep hematocrit below 45%. Takeda holds the exclusive global rights to develop and commercialize Rusfertide . This approval is supported by data from the global Phase III VEVERIFY study. This study was a randomized, multicenter, placebo-controlled clinical trial (n=293) designed to evaluate the efficacy and safety of rusfertide (once weekly, subcutaneously) in patients with PV. The primary endpoint of the study was response rate (the proportion of patients who did not require phlebotomy). The results ...
- Source: drugdu
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- August 31, 2026
The FDA has accepted the application for a new indication for Shuwozhe®, for first-line monotherapy in EGFR exon20ins non-small cell lung cancer

On August 30, 2026, Dizhe Pharmaceuticals (stock code: 688192.SH) announced that its self-developed novel lung cancer targeted drug, Shuvozhe® (shuvotinib), has been accepted by the U.S. Food and Drug Administration (FDA) for a new indication marketing application (sNDA) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). This application is based on the results of the Phase III international multicenter randomized controlled clinical trial “WU-KONG28”. This study aimed to evaluate the efficacy and safety of Shuwozhe® compared to platinum-based doublet chemotherapy in the first-line treatment of EGFR exon20ins NSCLC. The results showed that Shuwozhe® demonstrated a statistically and clinically significant improvement in progression-free survival (PFS) compared to platinum-based doublet chemotherapy. Detailed data have been presented as a Breakthrough Abstract (LBA) oral presentation at the 2026 American Society of Clinical Oncology (ASCO) ...
- Source: drugdu
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- August 31, 2026

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