Recent Articles in Trials & Approvals

Nanjing Biosion presented positive data from a Phase II proof-of-concept trial of Bosakitug, a high potency anti-TSLP mAb, in subjects with atopic dermatitis. 94% of the patients in the trial had an EASI response of 75% and 25% reported a 100% response. Bosakitug, Biosion’s lead drug candidate, has also started trials for severe asthma and chronic rhinosinusitis with nasal polyps, and it is in preclinical development for COPD. Biosion partnered China rights for Bosakitug with CTTQ and the US rights with Taiwan’s OBI Pharma. More details....

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Asia Scientific Global (ASG), a company developing inhaled forms of existing drugs, has built a laboratory in Taiwan, and it will establish a second facility in Singapore later this year. The new lab will develop 505(b)2 new dosage drugs targeting four key areas: antibiotics, erectile dysfunction, respiratory health and the central nervous system. For most of its products, ASG will use dry powder inhalers that deliver medication via the respiratory tract. ASG revealed today that Beta1, a novel drug aimed at erectile dysfunction, has completed toxicology testing and will start clinical trials soon. More details....

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Shanghai Junshi Bio said toripalimab (Tuoyi®), its anti-PD-1 mAb, met the progression free survival endpoint as a first-line treatment for advanced hepatocellular carcinoma. Toripalimab was administered along with bevacizumab (Avastin), Genentech’s anti-VGFR. The toripalimab-bevacizumab combination offered better progression free survival and overall survival compared to the current standard of care, sorafenib (Nexavar). Junshi will submit a supplemental NDA for the latest toripalimab indication soon; it is already approved for eight indications in China. More details....

Stock Symbols: (HK: 1877; SHA: 688180)

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Suzhou Ascentage Pharma was approved to start a China Phase III trial of olverembatinib (HQP1351) as a second-line therapy for succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST). Olverembatinib is an orally-available novel third-generation TKI developed by Ascentage Pharma. It its latest trials, olverembatinib achieved a clinical benefit rate of 92.3% in SDH-deficient GIST patients. With a median age of diagnosis of 21 years, the disease is more common in women. It arises primarily in the gastric area with a high propensity to metastasize. More details....

Stock Symbol: (HK: 6855)

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Vancouver’s Zymeworks announced that its BLA for zanidatamab, a HER2-targeted bispecific antibody, was accepted for review by China’s CDE as a second-line treatment for HER2-positive biliary tract cancer (BTC). Zanidatamab can simultaneously bind two non-overlapping epitopes of the HER2 receptor, known as biparatopic binding. In 2018, BeiGene acquired Asia Pacific rights to zanidatamab and several other Zymeworks candidates in a $1.1 billion agreement. Following a Phase IIb trial, Zymeworks and BeiGene filed the BLA, which triggered an $8 million milestone from to Zymeworks. More details....

Stock Symbol: (NSDQ: ZYME)

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