Generon (Shanghai) has been approved to start a China Phase I clinical trial for A-319, a bi-specific antibody, in patients with B cell malignancies. A-319, Generon's second bispecific antibody to start clinical trials, is a CD3/CD19 bispecific antibody ...


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Generon to Start China Phase I Trial of IO Drug in B Cell Malignancies

Written by Richard Daverman, PhD, Executive Editor, Greg B. Scott.

Generon (Shanghai) has been approved to start a China Phase I clinical trial for A-319, a bi-specific antibody, in patients with B cell malignancies. A-319, Generon’s second bispecific antibody to start clinical trials, is a CD3/CD19 bispecific antibody developed on the company's Immuno-Therapy Antibody (ITab)TM platform. The company will test A-319 in patients with B cell malignancies including acute lymphoblastic leukemia and B cell lymphoma. Generon is the biologics arm of Yifan Pharma. More details....

Stock Symbol: (SHZ: 002019)

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Week in Review: bioMérieux Acquires Majority Stake in China Diagnostics Company for $114 Million

Written by Richard Daverman, PhD, Executive Editor, Greg B. Scott.

Deals and Financings 

  • bioMérieux, a French in vitro diagnostics company, paid $114 million to acquire a majority stake in Suzhou Hybiome Biomedical, also an immunoassay company;
  • Ascendis Pharma of Denmark formed an $80 million China JV with Vivo Capital to develop its endocrinology rare disease therapies in Greater China;
  • Shanghai's Ocumension entered a $11.75 million deal for greater China rights to EyePoint Medical's medical device for long-term uveitis treatment;
  • Zhejiang Jingxin Pharma invested a second $10 million in Mapi Pharma of Israel, which is developing treatments for schizophrenia and pain;
  • Berry Genomics, a Beijing genomics testing company, will form a JV with Prenetics Limited to market direct-to-consumer genetic tests in China;
  • HuiyiHuiying of Beijing closed a funding round led by Intel Capital to develop its AI-based medical imaging program; 

Trials and Approvals 

  • Suzhou's Innovent dosed the first patient in a China Phase III trial of its anti-PD-1 mAb in patients with squamous NSCLC;

Company News 

  • Ping An Good Doctor installed the first of its One-Minute Clinics, a freestanding booth that dispenses AI-based healthcare diagnosis and medicine without any employees on site;

Government and Regulatory

  • The Shanghai Stock Exchange will set up a New Board for innovative science and technology companies, although detailed IPO requirements have not been released.

Stock Symbols: (Paris: BIM) (NSDQ: ASND) (NSDQ: EYPT) (SHZ: 000710) (HKEX: 1801) (HK: 01833)

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bioMérieux to Pay $114.5 Million for Majority Stake in Suzhou Hybiome

Written by Richard Daverman, PhD, Executive Editor, Greg B. Scott.

bioMérieux, a French in vitro diagnostics company, acquired a majority stake in Suzhou Hybiome Biomedical Engineering for $114 million. Hybiome specializes in automated immunoassay tests. Its installed base includes about 1,000 active instruments, which are used primarily in tier 2 China hospitals (100 to 500 beds). Based on a $187 million valuation for Hybiome, bioMérieux paid $101 million for its 54% stake, plus $13.5 million for additional assets such as distribution rights and existing installed base. More details....

Stock Symbol: (Paris: BIM)

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Denmark's Ascendis Forms $80 Million China Rare Disease JV with Vivo Capital

Written by Richard Daverman, PhD, Executive Editor, Greg B. Scott.

Ascendis Pharma of Denmark formed a China JV with Vivo Capital to develop its endocrinology rare disease therapies in Greater China. An investor syndicate, led by Vivo Capital, will own a 50% stake in Visen Pharma, the JV, in return for a $40 million investment. Sofinnova also participated in the funding. Ascendis will transfer China rights to three of its rare disease drugs into Visen and own the remaining 50%. The three Ascendis products -- TransCon hGH, TransCon PTH and TransCon CNP -- are in late-stage clinical trials outside of China.

Stock Symbols: (NSDQ: ASND)

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Innovent Starts Phase III Trial of PD-1 Candidate in Lung Cancer Patients

Written by Richard Daverman, PhD, Executive Editor, Greg B. Scott.

Suzhou's Innovent Biologics has dosed the first patient in a China Phase III trial of sintilimab, its anti-PD-1 mAb, in patients with advanced or recurrent squamous non-small cell lung cancer. The Phase III trial follows positive results from a small Phase I trial of sintilimab in the same population. Previously, Innovent started a Phase III trial of the candidate in patients with non-squamous cell NSCLC. In April, China's NMPA accepted Innovent's NDA for sintilimab as a treatment for Hodgkin's Lymphoma under priority rules. More details....

Stock Symbols: (HKEX: 1801) (NYSE: LLY)

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Written by Richard Daverman, PhD, Executive Editor, Greg B. Scott.


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