PharmaFocus Today – Page 6 – media

The first domestically produced HER2 bispecific antibody! Anituzumab from KNJ Pharmaceutical and CSPC Pharmaceutical Group has been approved for marketing

On May 28, the NMPA announced that it had approved the marketing of Anituzumab Injection (trade name: Enituzumab) submitted by Shanghai Jinmante Biotechnology through the priority review and approval procedure. This product, in combination with chemotherapy, is indicated for the treatment of locally advanced or metastatic HER2-positive adult patients with gastric or gastroesophageal junction adenocarcinoma who have previously received at least one trastuzumab-containing therapy . Anitumumab (KN026) was originally developed by KNJ Biopharma as a HER2 bispecific antibody that binds to two non-overlapping epitopes of HER2, blocking HER2 signaling. It enhances ADCC and CDC effects through antibody-induced receptor aggregation while downregulating cell surface HER2 receptors. In August 2021, KN026 was licensed to CSPC Pharmaceutical Group for a total transaction value of RMB 1 billion. Its wholly-owned subsidiary, Shanghai Jinmante Biotechnology, obtained exclusive rights to develop and commercialize KN026 in mainland China for breast cancer and gastric cancer indications. In November ...
- Source: drugdu
- 115
- June 2, 2026
Within a single day, Hisun Pharmaceuticals received FDA approval for its cyclopropanol product and subsequently signed a global research and development agreement with Eli Lilly.

On June 1, 2026, Hisun Pharmaceutical Group Co., Ltd. (hereinafter referred to as ” Hisco “) issued two announcements that are significant enough to be recorded in the annals of Chinese innovative drug exports. The first announcement stated that Hisun Pharmaceutical Technology (Lhasa) Co., Ltd., a wholly-owned subsidiary of the company, officially signed a “Licensing and R&D Cooperation Agreement” with Eli Lilly and Company on May 29, 2026. The two parties will conduct strategic cooperation in the research and development of innovative drugs in multiple disease areas . The second announcement stated that Hisun’s independently developed Class 1 intravenous anesthetic innovative drug— Cipepofol Injection (Chinese trade name: 思舒宁®, English trade name: CYPSEDO)—officially received marketing approval from the U.S. Food and Drug Administration ( FDA ) for the induction of general anesthesia in adults. Cippofol thus became the first original innovative intravenous anesthetic drug from China to enter the international market. ...
- Source: drugdu
- 143
- June 2, 2026
Xinhua Pharmaceutical’s Sevelamer Carbonate Dry Suspension Approved for Marketing

Recently, Xinhua Pharmaceutical’s sevelamer carbonate dry suspension (specifications: 0.8g; 2.4g ) received the Drug Registration Certificate issued by the National Medical Products Administration. The approval of this dosage form provides a new treatment option for patients with hyperphosphatemia due to chronic kidney disease ( CKD ). Hyperphosphatemia is a common complication in maintenance hemodialysis ( MHD ) patients and a challenge in their treatment. Studies show that almost all end-stage chronic kidney disease (CKD) patients have hyperphosphatemia, which is associated with adverse clinical outcomes. Therefore, it is recommended that CKD patients receive phosphorus-lowering therapy to achieve normal serum phosphorus levels. Sevelamer is a calcium-free, non-metallic phosphate binder. Its mechanism of action is to bind with phosphorus in the gastrointestinal tract, thereby reducing its absorption. Compared with metal-containing preparations such as calcium carbonate, it effectively avoids the risks of elevated blood calcium and metal accumulation. Sevelamer carbonate dry suspension is clinically ...
- Source: drugdu
- 95
- June 2, 2026
its poultry vaccine receives market approval.

Today (May 27), Merck announced that its Animal Health division’s live vaccine for infectious bronchitis (strain 4-91), Poultry Bibi® Spread ( hereinafter referred to as Spread® ) , has recently been approved by the Ministry of Agriculture and Rural Affairs of China for the prevention of infectious bronchitis caused by the 4-91 variant of the infectious bronchitis virus . acute, highly contagious respiratory disease caused by infectious bronchitis virus (IBV), a virus belonging to the genus Coronavirus in the family Coronaviridae . It has a short incubation period, spreads rapidly, and has a high morbidity rate, making it one of the major disease threats facing the global poultry industry. Based on the different tropisms of the virus to various organs and tissues of chickens, IB can be divided into respiratory, renal, reproductive, and intestinal types. Among them, chicks have the highest mortality rate after infection , while adult chickens mainly ...
- Source: drugdu
- 117
- May 29, 2026
With an investment of 2.95 million yuan in R&D, a blockbuster constipation product with a market value of 2.4 billion yuan was successfully developed.

Recently, Qianjin Pharmaceutical issued an announcement stating that its subsidiary, Qianjin Xiangjiang Pharmaceutical, has officially received approval from the National Medical Products Administration for the marketing of its generic drug ” Lactulose Oral Solution .” This drug will primarily be used for the treatment of chronic or habitual constipation, as well as the prevention and treatment of hepatic encephalopathy. Of particular note is the project’s return on investment . The announcement shows that Qianjin Xiangjiang Pharmaceutical’s cumulative R&D investment in lactulose oral solution is 2.9505 million yuan . According to data from Yaozhi, the total sales of lactulose oral solution in the domestic market reached 2.356 billion yuan in 2025 . This means that Qianjin Pharmaceutical has successfully entered a mature market with annual sales exceeding 2.3 billion yuan with a research and development cost of less than 3 million yuan. 01 A “long-standing” figure in the field of gastroenterology ...
- Source: drugdu
- 112
- May 29, 2026
InnoCare Pharma’s Oelabrutinib Receives Marketing Approval in Australia

Innovent Biologics (SSE: 688428; HKEX: 09969) today announced that orelabrutinib (product name: Enokai® ) has been approved for marketing by the Australian Therapeutic Goods Administration (TGA), providing better treatment options for patients with mantle cell lymphoma. Mantle cell lymphoma is a specific subtype of B-cell non-Hodgkin lymphoma (NHL), characterized by its aggressive nature and difficulty in achieving a complete cure, with its incidence rate increasing year by year. At diagnosis, the disease often progresses to an advanced stage, presenting challenges such as limited treatment options and a poor overall prognosis. Orelabrutinib is a highly selective, novel BTK inhibitor independently developed by InnoCare Pharma. It can effectively avoid adverse reactions caused by off-target effects and significantly improve the safety and efficacy of treatment. Currently, orelabrutinib has been approved in Singapore for the treatment of relapsed/refractory marginal zone lymphoma (R/R MZL) and relapsed/refractory mantle cell lymphoma (R/R MCL). In China, orelabrutinib has ...
- Source: drugdu
- 107
- May 29, 2026
Saisheng Pharmaceuticals’ novel antibiotic, telavancin hydrochloride for injection, has been launched in China.

[Shanghai, China, May 28, 2026] SciGene Pharmaceuticals today announced the official launch of its novel antibiotic, telavancin hydrochloride for injection, in China for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus. The commercial launch of telavin hydrochloride for injection in China provides a new treatment option that combines a unique dual bactericidal mechanism with clinical convenience for the treatment of infections caused by multidrug-resistant Gram-positive bacteria, especially severe pneumonia caused by methicillin-resistant Staphylococcus aureus (MRSA). Long-lasting antibacterial activity to combat drug resistance challenges Infections caused by Staphylococcus aureus are highly dangerous. With the widespread use of antibiotics, drug-resistant strains such as MRSA are constantly emerging, exhibiting resistance to multiple antibiotics and sensitivity only to a few drugs such as vancomycin. Furthermore, even within the same class of antibiotics, different subspecies may exhibit differences in antibacterial activity. Tieravancin hydrochloride for injection is a ...
- Source: drugdu
- 114
- May 29, 2026
AbbVie CD123 ADC Approved for Market Launch

On May 27, AbbVie announced that Decnupaztm (Pivekimab sunirine-pvzy) has received FDA approval for the treatment of adult patients with blastic plasmacytoid dendritic cell tumors (BPDCN). Pivekimab sunirine-pvzy is the world’s first approved CD123 ADC . CD123 (IL-3Rα) is a protein overexpressed in BPDCN and is an ideal therapeutic target. This approval is supported by data from the Phase I/II CADENZA study. This study was a multicenter, open-label clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and antileukemic activity of pivekimab sunirine-pvzy in patients with CD123-positive hematologic malignancies, including BPDCN. The results showed that newly diagnosed BPDCN patients treated with pivekimab sunirine-pvzy exhibited clinically significant and durable responses. In newly diagnosed BPDCN patients (n=33), the overall complete response rate was 69.7%, with a median duration of response (DOR) of 9.7 months, and 13 patients (39.4%) were able to receive stem cell transplantation after the study. In relapsed or refractory BPDCN ...
- Source: drugdu
- 115
- May 29, 2026
GSK’s First-Ever Hepatitis B Drug Resubmits Marketing Application in China

On May 27, the CDE (Center for Drug Evaluation) website showed that GlaxoSmithKline (GSK) has resubmitted its marketing application for its new chronic hepatitis B drug, Bepirovirsen injection. Bepirovirsen was first submitted for marketing approval in China on March 27 this year, with the indication being limited-course treatment of chronic hepatitis B virus infection in adults with chronic hepatitis B virus infection who are currently receiving nucleoside (nucleotide) analogue therapy, have HBsAg ≤3000 IU/mL, and do not have cirrhosis. On May 21, the application received a drug notification from the National Medical Products Administration (NMPA). Beprovirsen is an antisense oligonucleotide (ASO) therapy acquired by GSK from Ionis. It aims to inhibit the replication of hepatitis B virus DNA, thereby suppressing the level of hepatitis B surface antigen (HBsAg) in the blood and stimulating a sustained immune response. This drug is the first small nucleic acid drug in the field of ...
- Source: drugdu
- 103
- May 29, 2026
Bombshell! Eli Lilly Spends Nearly $4 Billion to Acquire Three Drug Firms, Returning to the Vaccine Track

On May 26 (today), Eli Lilly announced agreements to acquire three vaccine companies — Curevo Inc., LimmaTech Biologics AG, and Vaccine Company, Inc. — officially entering the human vaccine arena. This acquisition is part of Eli Lilly’s strategy to continuously invest in differentiated technology platforms and tackle major health challenges. In its 150-year history, Lilly has made significant progress in diabetes, obesity, Alzheimer’s disease, autoimmune diseases, and cancer. Infectious diseases, as a major driver of global morbidity, still pose unresolved public health challenges in terms of acute illness and long-term health consequences from primary infections. Dr. Daniel M. Skovronsky, Eli Lilly’s Chief Scientific and Product Officer and President of Lilly Research Laboratories, stated that this acquisition reflects the company’s strategic direction of preventing disease at its source rather than merely treating its consequences. Existing research shows that common infections may trigger neurological diseases, cancer, infertility, and other conditions years later. ...
- Source: drugdu
- 109
- May 27, 2026

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