Deals and Financings

Beijing's BeiGene (NSDQ: BGNE; HK: 06160) will receive a $150 million termination payment from Celgene (NDSQ: CELG) because Celgene will end its $1.4 billion partnership for ex-China rights to BeiGene's PD-1 candidate (see story). The original deal included a provision that BeiGene's tislelizumab would be Celgene's only PD-1 project. Once Celgene agreed to be acquired by Bristol-Myers Squibb (NYSE: BMY), tislelizumab was in jeopardy, given BMS's very successful anti-PD-1 antibody, Opdivo. In 2017, Celgene paid $263 million upfront for ex-China rights to tislelizumab.

Akeso Pharma of Zhongshan formed a $100 million JV with Chia Tai Tianqing Pharma (CTTQ), a subsidiary of Sino Biopharma (HK:1177), to develop and commercialize its clinical-stage anti-PD-1 mAb (see story). CTTQ will contribute $50 million to the JV for a 50% stake. Akeso will add marketing rights to AK105, IP and technology for its half. CTTQ will be in charge of marketing the immunotherapy. According to Akeso, clinical tests of AK105 have shown it has better anti-tumor cell activity than its competitors. AK105 is also approved to start US trials.

CASI Pharma (NSDQ: CASI), a US-China company, obtained global rights to an autologous anti-CD19 T-cell therapy developed by Juventas Cell Therapy of Tianjin City, China (see story). Juventas has filed China INDs to test CNCT19 as a treatment for two leukemia and lymphoma indications. A CASI 80%-owned China subsidiary will invest $11.6 million in Juventas instead of an upfront payment. CASI will make development milestone payments and pay sales royalties, though details were not disclosed. Juventas will continue to develop CNCT19 with CASI's participation on the program's steering committee.

Beijing's BeiGene (NSDQ: BGNE; HK: 06160) and SpringWorks Therapeutics of Stamford, Connecticut have joined to form MapKure, which will initially be in charge of non-Asia clinical development of BeiGene's B-RAF inhibitor (see story). SpringWorks will contribute cash to MapKure, while BeiGene will own a majority stake in the company in return for a global royalty and milestone-bearing license to develop and commercialize BGB-3245 outside of Asia (but including Japan). B-RAF mutations are thought to cause the growth of several solid tumor cancers.

Jiangsu Hengrui Medicine (SHA: 600276) in-licensed greater China rights to a treatment for chronic yeast infections from Mycovia Pharma of Durham, North Carolina (see story). Mycovia is currently conducting a Phase III trial of VT-1161 (otesaconazole) in women with recurrent vulvovaginal candidiasis (RVVC) in the US, the EU and Japan. A novel oral therapy, VT-1161 is designed to have greater selectivity, fewer side effects and improved potency than current treatments. Mycovia believes it may also be effective for other systemic fungal infections.

Trials and Approvals

Hutchison China MediTech (Chi-Med) (AIM/NSDQ: HCM) will stop its Phase III trial of surufatinib early following positive interim data showing the candidate met its primary endpoint of progression-free survival (see story). The China trial was testing surufatinib in patients with advanced non-pancreatic neuroendocrine tumors. With a dual anti-angiogenesis, anti-microphage mechanism, surufatinib is designed to promote the body's natural immune response to cancer. It is expected to be used together with other immunotherapies.

Suzhou Innovent Biologics (HK: 01801) reported that its fully-human BCMA CAR-T candidate produced a 100% objective response rate in patients with relapsed/refractory multiple myeloma (RRMM) (see story). CT103A was co-developed by Innovent and Nanjing IASO Biotherapeutics. It is aimed at RRMM patients who do not respond initially to murine-based BMCA CAR-T drugs or those who relapse. Innovent said most patients relapse between three and five years after initial treatment, with existing treatments offering a poor prognosis.

Gracell Biotechnologies, a Suzhou immunotherapy company, announced positive preliminary results from a trial of its FasT CAR-19 investigational cell gene therapy (see story). Gracell's FasT CAR product reduces preparation time to 24 hours, compared to an average of two weeks in other genetically modified T-cells candidates. In a group of 16 adolescent and adult patients with B-cell acute lymphoblastic leukemia (B-ALL), all 16 achieved complete remission (with or without complete blood count recovery). Each of the patients had been previously treated with multiple therapies.

Shanghai Henlius, a biosimilar/innovative biologics subsidiary of Fosun Pharma (SHA: 600196; HK: 02196), reported the European Medicines Agency (EMA) accepted its Marketing Authorization Application of a Herceptin (trastuzumab) biosimilar for review (see story). The company says HLX02 is the first China-developed biosimilar to achieve this milestone, as well as the first China-developed trastuzumab biosimilar accepted in China. The candidate is indicated for HER2+ breast cancer and untreated HER2+ metastatic gastric/gastroesophageal junction (GEJ) cancer. Henlius has out-licensed European rights for HLX02 to Accord Healthcare.

Cellular Biomedicine (NSDQ: CBMG), a New York-Shanghai company, started a China Phase I trial of its CD20 CAR-T candidate in patients who relapsed after CD19 treatment (see story). The patients have either relapsed diffuse large B-cell lymphoma or small B-cell lymphoma. The Phase I trial will enroll an initial 12 patients to evaluate the treatment's safety and efficacy. In addition, Cellular Bio is close to starting trials for its Alpha Fetoprotein T-cell Receptor candidate in liver cancer and its next-gen Tumor Infiltrating Lymphocytes in non-small cell lung cancer patients.

CARsgen Therapeutics, a Shanghai CAR-T company, was approved to start US trials of its fully human BCMA (B-Cell Maturation Antigen)-CAR-T therapy for patients with relapsed/refractory multiple myeloma (see story). Four months ago, China's NMPA approved a similar IND for CT053, and it has begun China clinical trials. So far, CT053 has been administered to 24 heavily pre-treated patients in the China trial. CARsgen said 87.5% of them showed a response, and 70.8% had a complete response. No patients had cytokine release syndrome higher than grade 2.

Company News

dMed Biopharma, a Shanghai clinical CRO, has opened a Washington office to help China biopharmas complete their US regulatory filings (see story). Since 2017, China's harmonization with the regulatory systems of other countries revolutionized the opportunities for China biopharmas, the company said. The number of US INDs filed by China biopharmas jumped from 11 in 2016 to 38 in 2018, a number that was equaled in the first quarter of 2019 alone. Among other things, the dramatic rise reflects the effect of numerous China-developed CAR-T candidates. dMed's Washington office is led by Dr. Eric Zhang, a former FDA reviewer.

Disclosure: none.