Alphamab Oncology, a company developing eight bispecifics for oncology, plans to stage an IPO before the end of the year on the Hong Kong Exchange that could raise up to $350 million (see story). Alphamab Oncology is a spin out from Suzhou Alphamab. The company plans to use the proceeds from the offering to support clinical development of its portfolio, including KNO46, which could be a first-in-class bispecific antibody against CTLA-4 and PD-1. The company will sell about 25% of its shares in the offering, giving it a valuation of more than $1 billion.

Luye Pharma (HK: 2186) of Yantai acquired Shandong Boan Biological, a company developing biosimilar products, at a price unofficially reported to be $205 million (see story). Luye said the acquisition includes Boan's drug portfolio, antibody screening platform, antibody manufacturing platform and related IP. Boan currently has eight biosimilar drugs in development, three of them in clinical trials. Previously, Luye in-licensed four biosimilars from Boan, including biosimilars to Avastin®, Prolia®, Xgeva® and Eylea®. Luye said the molecules are at the IND stage in the US and/or Europe and/or Japan.

EOC Pharma, the oncology development arm of China in-licensing company Eddingpharm, raised $71 million in a Series C round led by Tigermed, TF Capital and Yingke PE (see story). Headquartered in Taizhou, EOC manufactures and commercializes oncology products for China use that require mid to late stage clinical development for registration. It currently has a pipeline of six novel products from global biopharmas, including its most recent in-licensing, a Shionogi HER2/EGFR inhibitor intended to treat brain metastasis in advanced metastatic breast cancer patients. Two years ago, EOC completed a $32 million B financing.

Suzhou Ribo Life Science, a siRNA drug development company, raised $29 million in a series C1 financing led by Panlin Capital and Trinity Innovation Fund (see story). Founded in 2007, Ribo formed a China JV in 2012 with Quark Pharma, a US siRNA company. The Quark JV produced Ribo's first China-approved therapy, a treatment for Ischemic Optic Neuropathy. The company claims expertise in small nucleic acid drug discovery, scale-up and production. Ribo, which has six Quark-partnered drug candidates plus four of its own molecules in development, says the siRNA treatments address multiple needs.

Beijing Hygea Medical Technology closed a $28 million Series B funding to develop its minimally invasive cryogenic treatment for cancer (see story). The round was led by Jianxing Medical Fund under the management of CCB International, with participation from Kunying Capital and Shuncheng Capital. Hygea holds 14 patents for its proprietary HYG KB Cryosurgical System and HYG KBD Sterile Cryosurgical Probes. It is also developing cancer diagnostics. An affiliate of the China Academy of Sciences, Division of Physics and Chemistry, Hygea has been supported by China's 863 program and other China national and Beijing funds.

Singapore's Aslan Pharma (Nasdaq: ASLN; TPEx: 6497) raised $12.8 million in a secondary offering of its NASDAQ listed ADSs, placing 5.12 million ADSs at $2.50 each (see story). The price of its shares have been on a seven-day roller coaster, rising 12-fold starting from a low on November 22, when Aslan announced preliminary signs of efficacy in a preclinical study of ASLAN003 for acute myeloid leukemia. The rally was cut in half yesterday when Aslan said it would conduct a secondary offering, without releasing details. Today, after announcing terms for the deal, Aslan trading lower by an additional 47% at $2.73, a market capitalization of just under $20 million.

ViGeneron GmbH of Munich closed a Series A round led by two China investors, WuXi AppTec and Sequoia Capital China (see story). The company will use the proceeds to advance its proprietary viral vector-based gene therapy platforms and develop its two lead ophthalmic gene therapy candidates. ViGeneron's pipeline is built on two proprietary adeno-associated virus (AAV) technology platforms: vgAAV gene therapy vectors, which allow superior transduction efficiency and intravitreal, less invasive treatment administration; and REVeRT vectors, which target diseases caused by mutations in large genes.

Trials and Approvals

Suzhou Innovent (HK: 01801)has dosed the first patient in a China Phase I trial of its anti-lymphocyte activation gene 3 (LAG-3) candidate in patients with advanced malignancies (see story). A novel immunotherapy, IBI110 will be studied as a monotherapy and in combination with Tyvyt®, Innovent's approved anti-PD-1 antibody drug. IBI110 is designed to bind to LAG-3 on the surface of T cells and disturb the interaction between LAG-3 and MHCII, relieving the inhibiting effect of LAG-3 on T cell activation. Its mechanism is expected to be synergistic with PD-1/PD-L1 drugs.

AstraZeneca (NYSE: AZN) and Merck/MSD (NYSE: MRK) were approved to sell their jointly marketed PARP inhibitor in China as a first-line maintenance treatment for BRCA-mutated ovarian cancer (see story). In a Phase III trial among patients who responded to platinum-based chemotherapy, 60% of Lynparza patients hit the 36-month point without disease progression or death, against 27% for women receiving placebo, a 70% improvement. Results of the Phase III SOLO-1 trial showed 15% of ovarian cancer patients have a germline (inherited) BRCA 1/2 mutation and 7% have a somatic (acquired) mutation.

Innovative Cellular Therapeutics (ICT), a Shanghai-US CAR-T company, reported the US FDA approved its IND for ICTCAR014, a next gen CD19-targeting CAR-T cell therapy (see story). ICT said ICTCAR014 expresses a dominant negative PD-1 protein to block immunosuppression by cancer cells. The company expects the US trial will test ICTCAR014 in patients with relapsed or refractory non-Hodgkin lymphoma, including patients with PD-L1 positive tumors. ICT, which has already completed a China trial of ICTCAR014, plans to move its products rapidly through proof-of-concept trials in China and then expand into US and global development.

Bio-Thera (NYSE: JNJ), a Guangzhou biotech, was approved by China's National Medical Products Administration to start a Phase I trial that compares its Stelara® biosimilar to the original (see story). Johnson & Johnson's Stelara is indicated to treat immune disorders including Crohn's disease, ulcerative colitis and psoriasis conditions. The China trial, which will test the pharmacokinetics and safety of Bio-Thera's BAT2206, will enroll about 270 healthy volunteers. BAT2206 will be the fifth Bio-Thera biosimilar to begin clinical trials.

CASI Pharma (Nasdaq: CASI) announced China approval to start clinical trials of CNCT19, a CD19 CAR-T treatment, in leukemia and lymphoma patients (see story). Earlier this year, CASI acquired global rights to the candidate from Juventas Cell Therapy of Beijing in exchange for an $11.6 million investment in Juventas rather than an upfront payment. Juventas retains responsibility for trials of CNCT19. CASI, a Maryland-China biopharma, said the CD19 CAR-T therapy will be tested in patients with relapsed/refractory B-cell acute lymphoblastic leukemia and relapsed/refractory B-cell non-Hodgkin lymphoma.

Government and Regulatory

China's National Healthcare Security Administration announced that 70 drugs have been added to the list of drugs eligible for insurance reimbursement after biopharmas agreed to price cuts that averaged 61% (see story). Two new products from western companies, anemia treatment roxadustat from AstraZeneca and lung cancer therapy alecensa from Roche, are now covered by China's insurance plan. And China's domestic PD-1 therapy for Hodgkin’s lymphoma, Tyvyt, co-developed by Suzhou's Innovent and Eli Lilly, was also added, the first PD-1 on the list, even though China has five approved PD-1/PD-L1 products, including two from the US. By including Tyvyt in the reimbursement list, the NHSA may have given Tyvyt a big boost in early market positioning.