PharmaFocus Today – Page 2 – media

IASO Bio’s in vivo CAR-T IASO208 receives FDA clinical trial clearance

On September 16, IASO Biotherapeutics announced that its investigational new drug application for IASO208, a CD20-targeting in vivo CAR-T product developed on its proprietary InTelliCAR platform, has received FDA clearance in the U.S. As the first lentiviral vector-based in vivo CAR-T product from China to receive FDA IND clearance, IASO208 will directly proceed to a Phase Ib study based on Chinese investigator-initiated trial data, targeting relapsed/refractory B-cell non-Hodgkin lymphoma. In vivo CAR-T is a next-generation cell therapy technology that eliminates the need for ex vivo T cell engineering, instead delivering vectors directly in patients to generate CAR-T cells in vivo. This approach has the potential to dramatically reduce treatment costs and timelines, moving cell therapy toward “off-the-shelf.” The FDA clearance for IASO208 signifies that China is competing on par with the international community in the in vivo CAR-T space, further deepening IASO Biotherapeutics’ internationalization in cell therapy. Source: http://m.toutiao.com/group/7686078944797311529/
- Source: drugdu
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- September 17, 2026
NMPA accepts marketing registration application for Velsipity domestic manufacturing transfer

On September 17, Everest Medicines announced that CDE of the NMPA has accepted the marketing registration application for Velsipity (etrasimod arginine tablets) for the transfer of manufacturing from overseas to domestic production, and has granted Priority Review. Local production is expected to commence in 2027. Velsipity was approved by NMPA in February 2026 for adult patients with moderate to severe active ulcerative colitis (UC) who have an inadequate response, loss of response, or intolerance to conventional therapies or biologics. Source: https://finance.eastmoney.com/a/202609173876680142.html
- Source: drugdu
- 134
- September 17, 2026
Ziprasidone mesylate from SSY Group has been approved for registration as an active pharmaceutical ingredient.

On September 16, SSY Group announced that its ziprasidone mesylate has been approved by the NMPA of China for registration as an API used in marketed formulations. Ziprasidone mesylate is primarily used to treat acute agitation symptoms in patients with schizophrenia. According to the announcement, SSY Group has built a leading second-generation antipsychotic HPAPI platform in China, covering blonanserin, lurasidone, ziprasidone hydrochloride, and the newly approved ziprasidone mesylate. Source: https://finance.eastmoney.com/a/202609163876154835.html
- Source: drugdu
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- September 17, 2026
Kanghong Pharmaceutical’s research on Shugan Jieyu Capsules won the first prize of the Science and Technology Award of the Chinese Pharmaceutical Association.

The 21st Chinese Pharmaceutical Association Science and Technology Award was presented at the 2026 Chinese Pharmaceutical Congress. The project “New Drug Creation and Industrial Innovation for Antidepressants Combining Traditional Chinese Medicine Syndromes,” in which Kanghong Pharmaceutical played a significant role, won the first prize. The Chinese Pharmaceutical Association Science and Technology Award was officially approved by the Ministry of Science and Technology in July 2005. It is sponsored by the Chinese Pharmaceutical Association and recognizes researchers and innovative achievements that have made major breakthroughs in pharmaceutical science. It is a highly prestigious and influential award in the domestic pharmaceutical field. Kanghong Pharmaceutical’s Shugan Jieyu Capsules are the core landmark achievement of this award-winning project. As the first approved traditional Chinese medicine for mild to moderate depression in China, this product is a Class II protected TCM variety and was recently included in the National Essential Medicines List (2026 Edition). Since ...
- Source: drugdu
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- September 17, 2026
Johnson & Johnson celebrates the launch of Rybrevant FASPRO (amivantamab subcutaneous injection) in China

As China’s first and currently only approved subcutaneous injection formulation for the treatment of EGFR-mutant advanced non-small cell lung cancer, Rybrevant FASPRO reduces the administration time from several hours with traditional intravenous infusion to just minutes, and significantly reduces the risk of infusion-related adverse reactions. Johnson & Johnson today announced the official launch of Rybrevant FASPRO (amivantamab injection, subcutaneous) in China, in combination with LECLIZE (lazertinib mesylate tablets) for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or exon 21 L858R substitution mutation. Rybrevant FASPRO is the first and currently only subcutaneous injection formulation approved in China for the treatment of patients with EGFR-mutant advanced NSCLC. Combined with lazertinib, it demonstrates significant ease of administration in first-line combination therapy, reducing administration time from several hours to just minutes. In terms of safety, compared with the intravenous formulation, Rybrevant ...
- Source: drugdu
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- September 17, 2026
First! Novartis’ blockbuster generic radiopharmaceutical receives approval

On September 14, Curium announced that Bexlutry ([177lu]oxooctreotide, development code: PNT2003) had received FDA approval. This drug is Lutathera ([177lu]oxooctreotide), i.e., a generic version. This is the world’s first approved generic radiopharmaceutical. The original drug, Lutathera, is a radioligand therapy (RLT) targeting the somatostatin receptor type 2 (SSTR2), acquired by Novartis through its acquisition of Advanced Accelerator Applications. It was first approved for marketing in the European Union in 2017. Currently, the drug is indicated for adult patients and children aged 12 years and older with unresectable or metastatic, progressive, well-differentiated (G1 and G2) SSTR-positive gastroenteropancreatic neuroendocrine tumors (GEP-NET). According to Novartis’ financial report, Lutathera’s global sales were $816 million in 2025. In November 2022, Lantheus acquired exclusive global rights to PNT2003 from POINT Biopharma, excluding China, Japan, South Korea, Indonesia, and Singapore. In October 2023, Eli Lilly acquired POINT Biopharma for $1.4 billion, gaining the remaining rights to the ...
- Source: drugdu
- 92
- September 17, 2026
Five innovative drugs approved for marketing

Recently, the National Medical Products Administration (NMPA) approved the marketing of five innovative drugs: Deuterated Aitinib Mesylate Tablets, Icosine Hydrochloride Tablets, Varigratetinib Tartrate Tablets, Veritumab Injection, and Lyconchitatumab Injection (subcutaneous). All five drugs were approved through the priority review and approval process. The NMPA conditionally approved the marketing of Deuterated Aitinib Mesylate Tablets submitted by Zhejiang Tongyuankang Pharmaceutical, indicated for adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletion or exon 21 substitution mutation, accompanied by central nervous system metastasis. The NMPA approved the marketing of Icosine Hydrochloride Tablets submitted by Janssen-Cilag, indicated for adult patients and children aged 12 years and above with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The NMPA conditionally approved the marketing of Varigratetinib Tartrate Tablets submitted by Hutchmed, indicated for adult patients with advanced, metastatic, or unresectable intrahepatic cholangiocarcinoma with FGFR2 fusion or ...
- Source: drugdu
- 98
- September 11, 2026
Subsidiary’s novel coronavirus mRNA vaccine receives drug registration certificate

On September 10, Walvax Bio (300142) announced that its wholly-owned subsidiary, Yuxi Walvax, recently received the “Drug Registration Certificate” for the novel coronavirus mRNA vaccine issued by the National Medical Products Administration (NMPA). This vaccine is the company’s third-generation COVID-19 mRNA vaccine, developed iteratively based on its mRNA platform technology strategy. The marketing authorization application was submitted and accepted earlier this year. The vaccine is designed based on the JN.1 strain and is indicated for individuals aged 18 years and above for the prevention of diseases caused by novel coronavirus infection. In the first half of 2026, Walvax Bio achieved revenue of 834 million yuan and net profit attributable to the parent company of 54.19 million yuan. Source: Eastmoney | https://finance.eastmoney.com/a/202609103870738792.html
- Source: drugdu
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- September 11, 2026
Lincomycin Hydrochloride Injection passes generic drug consistency evaluation

On September 10, Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Hefeng Pharmaceutical Co., Ltd., recently received the “Drug Supplementary Application Approval Notice” for Lincomycin Hydrochloride Injection issued by the National Medical Products Administration (NMPA). The drug has passed the generic drug quality and efficacy consistency evaluation. This drug is indicated for respiratory tract infections, skin and soft tissue infections, etc., caused by susceptible bacteria such as Streptococcus, Pneumococcus, and Staphylococcus aureus. Source: Eastmoney | https://finance.eastmoney.com/a/202609103870825889.html
- Source: drugdu
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- September 11, 2026
CSPC Pharmaceutical Group’s innovative chemical drug SYH2083 eye drops approved for clinical trials in China

On September 8, CSPC Pharmaceutical Group (1093.HK) announced that its Class 1 innovative chemical drug, SYH2083 eye drops, has been approved by the National Medical Products Administration (NMPA) of the People’s Republic of China to conduct clinical trials in China. This product is a small-molecule ophthalmic formulation with a novel mechanism of action. It treats ocular surface inflammation-related diseases by reducing T lymphocyte adhesion and activation, thereby lowering pro-inflammatory signals. Preclinical studies have shown that this product demonstrates significant pharmacodynamic activity in a mouse dry eye model, with a clear mechanism of action, indicating good clinical development potential. The approved clinical trial indication is dry eye syndrome, and the product also has the potential to be extended to other inflammatory ocular surface diseases such as allergic conjunctivitis. The approval of this product’s clinical trial will further enrich the Group’s innovative drug pipeline in the ophthalmology field. Source: WeChat Official Account ...
- Source: drugdu
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- September 11, 2026

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