PharmaFocus Today – Page 12 – media

Japanese pharmaceutical company’s “COVID-19 prevention drug” receives FDA approval

On June 1, Shionogi & Co., Ltd. of Japan announced that the U.S. FDA had approved its oral antiviral drug XOCOVA (ensitrelvir) for post-exposure prophylaxis against COVID-19. This is currently the first and only oral post-exposure prophylaxis drug approved in the U.S. market. Ensitrelvir is a 3CL main protease inhibitor targeting SARS-CoV-2 , jointly developed by Hokkaido University and Shionogi & Co., Ltd. This drug selectively inhibits the activity of the main protease essential for viral replication, blocking viral amplification in the body. Ensitrelvir is administered orally as a single agent . The FDA approval was based on the results of the global, multicenter, double-blind, randomized, placebo-controlled phase 3 clinical trial SCORPIO-PEP . The study enrolled nearly 2,400 household contacts living with COVID-19 patients in the United States, Argentina, Japan, South Africa, and Vietnam. Participants began taking medication within 72 hours of the index case developing symptoms. Data from the ...
- Source: drugdu
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- June 4, 2026
Bristol-Myers Squibb’s new anticancer drug is proposed to be included in the priority review process

On June 3, the Center for Drug Evaluation (CDE) published a notice on its website stating that Bristol-Myers Squibb’s (BMS) Mezigdomide capsules are proposed for inclusion in the priority review and approval process. The proposed indication is for use in combination with carfilzomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received lenalidomide and anti-CD38 monoclonal antibody therapy. It is understood that this drug was recently granted Breakthrough Therapy designation by the CDE. Multiple myeloma is a difficult-to-cure hematologic malignancy, and even after multiple lines of treatment and achieving remission, almost all patients eventually relapse. With each line of treatment, the patient’s response rate to subsequent therapies and the duration of remission gradually decrease, which is a core challenge in the treatment of multiple myeloma. At the ASCO 2026 Annual Meeting, Bristol-Myers Squibb announced positive breakthrough results from the Phase III SUCCESSOR-2 ...
- Source: drugdu
- 127
- June 4, 2026
Chia Tai Tianqing Pharmaceutical Group and Shionogi have collaborated on a major project, Xinpuluo® (Nadimethicone), which has been approved for marketing in China.

On May 29, the official website of the National Medical Products Administration (NMPA) showed that Naldemedine (generic name: Naldemedine tosylate tablets, trade name: Symproic® ) was approved for marketing for the treatment of opioid-induced constipation (OIC) in adults [ 1] . The approval of this innovative drug will provide patients suffering from OIC with a new treatment option to improve their quality of life (QOL) and promote the overall improvement of the level of supportive care for tumors in China. In January 2025, Chia Tai Tianqing Pharmaceutical Group, a core enterprise of China Biopharmaceutical (1177.HK), signed an agreement with Shionogi to obtain the exclusive marketing rights of Naldemedine in mainland China. Nadecamide is the world’s first approved oral selective peripheral μ-opioid receptor antagonist. By blocking the binding of opioids to μ receptors in the intestine, it directly restores the normal peristaltic rhythm and intestinal fluid secretion function, thus reversing the ...
- Source: drugdu
- 164
- June 2, 2026
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
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- 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
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- 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
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- 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
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- 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
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- 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
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- 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
- 148
- May 29, 2026

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