IPO Watch

On Monday, the first batch of young China high-tech companies soared higher as they began trading on Shanghai's brand-new STAR Exchange -- the first 25 companies to IPO on the exchange climbed an average of 140% (see story). The most outstanding result was a 521% jump for Anji Microelectronics, a small semiconductor company, while the laggard of the group was able to muster "only" an 88% gain. Together the IPOs raised $5.2 billion for the 25 companies, about 20% more than expected. No biopharma companies were included in the initial group of STAR IPOs, though ChipScreen is scheduled for next week.

Deals and Financings

Qihan Biotech, a Hangzhou startup, completed a $20 million B round to advance its use of CRISPR Cas-9 gene editing to allow xenotransplantation, the use of animal organs as transplants (see story). The round was led by CMB International and Legend Star. Qihan's goal is to remedy the global shortage of human organs for transplants. The company was founded by the chief scientist of eGenesis, Luhan Yang, PhD, and Harvard professor George Church, PhD. eGenesis is also focused on the use of CRISPR Cas-9 gene editing to enable xenotransplantation.

Zhejiang Mingdu Zhikong Technology raised $14 million in a Series A that it will use to advance its smart manufacturing programs for pharmaceutical development, production and distribution, which it offers to China pharmas (see story). The A round was led by Cash Capital and included Collaborative Innovation Investment. Mingdu Tech will also use the funds for promotion and development of the improved programs. Founded in 2017, Mingdu Tech uses AI and big data to develop its offerings.

Jiangsu Wanbang Biopharma, a subsidiary of Fosun Pharma (SHA: 600196; HK: 02196), acquired China rights to an anti-seizure treatment from New Jersey's Aucta Pharma (see story). Last year, the product, Vigabatrin for Oral Solution, was approved in the US, one of very few FDA-approved treatments for infantile spasms (IS) and certain adults with complex partial seizures whose seizures remain uncontrolled by other anti-epileptics. Aucta is currently seeking an import drug license for Vigabatrin from China's NMPA. Wanbang specializes in treatments for endocrinology, cardiovascular and renal conditions.

Trials and Approvals

Belgium's UCB (Euronext: UCB) was granted a China license to import Cimzia®, a biologic drug, to China for patients with moderate-to-severe rheumatoid arthritis (see story). China's NMPA granted the approval following a priority review. Cimzia is an anti-TNF biologic with a unique Fc-free molecular structure. In the Phase III trial, it was administered in combination with methotrexate and compared to methotrexate alone. To promote Cimzia, UCB will partner with Cinkate, a US-China pharma that already markets a disease modifying anti-rheumatic drug, leflunomide, in China.

Innovent Bio (HK: 01801) of Suzhou started a China trial that combines its China-approved PD-1 drug with its Avastin biosimilar to treat lung cancer (see story). The trial, ORIENT-31, will enroll 480 patients with EGFR-mutant NSCLC who were previously treated with a EGFR-TKI drug. Earlier this year, Tyvyt®, the PD-1 immunotherapy developed jointly by Innovent and Lilly (NYSE: LLY), was approved in China to treat relapsed or refractory classical Hodgkin's lymphoma. It is currently being tested in the US and China for additional indications. Innovent's Avastin biosimilar is not yet approved.

CStone Pharma (HK: 2616) of Suzhou was approved by China's NMPA to begin a Phase I bridging study of ivosidenib (Tibsorovo®) to treat relapsed or refractory acute myeloid leukemia (R/R AML) with an IDH1 mutation (see story). One year ago, CStone acquired China rights to ivosidenib from Boston's Agios (NSDQ: AGIO) in a $424 million agreement. Agoix was approved to market the drug in the US last year. The stand-alone China trial is designed to evaluate the efficacy, safety and pharmacokinetics of ivosidenib in China patients with IDH1 mutant R/R AML.

Ascentage Pharma, a Suzhou company specializing in apoptosis drugs, was approved to conduct a US Phase Ib clinical trial of its BCR-ABL tyrosine kinase inhibitor to treat drug-resistant chronic myeloid leukemia (CML) (see story). HQP1351 was designed to address acquired drug resistance caused by imatinib (Gleevec), which occurs in 20-30% of all CML patients. Ascentage's candidate is an oral, third-gen BCR-ABL TKI designed to target a broad spectrum of BCR-ABL mutants, including the T315I mutation. HQP1351 is the sixth Ascentage candidate accepted to start US trials.

Company News

Yisheng Biopharma of Beijing announced its new $60 million rabies vaccine production facility was awarded a GMP Certificate by China's National Medical Products Administration (see story). The NMPA approved the facility to produce Yisheng Junan™, the first China lyophilized rabies vaccine approved for human use without an aluminum adjuvant. Currently, Yisheng is conducting a Phase III trial of its next-gen rabies vaccine, using its novel PIKA® vaccine adjuvant to accelerate the vaccine's immune response. The PIKA-Rabies Vaccine has been granted Orphan Drug Designation in the US.

Accuray (NSDQ: ARAY), a Silicon Valley maker of radiation oncology machines, reported its China JV, CNNC Accuray, broke ground recently on a Tianjin manufacturing facility and education center, which will serve as its China operational base (see story). The JV expects to begin manufacturing devices at the facility in about two years. The JV also received approval to sell and install its radiation therapy devices in China. In January, Accuray formed the JV with CNNC High Energy Equipment (Tianjin), a subsidiary of China Isotope and Radiation (HK: 01763).

Disclosure: none.