Deals and Financings

NiKang Therapeutics, a clinical stage Delaware biotech, raised $200 million in a Series C financing from US and China investors (see story). NiKang was originally incubated by CBC Group (C-Bridge Capital) in 2017. It focuses on innovative small molecule oncology medicines that are discovered based on target structure biology and using structure-based drug design. The company believes its strategy speeds the process and offers better pharmacological candidates. The C round was led by Cormorant Asset Management, HBM Healthcare Investments and Octagon Capital Advisors.  

Esco Lifesciences of Singapore, an Asia-based life sciences tools company, closed an over-subscribed $200 million Series A and crossover round (see story). The financing will support strategic bolt-on M&A acquisitions and expedited expansion in China, the company's primary and fastest-growing market. Esco also intends to expand its cell and gene therapy tools and technologies portfolio, together with an innovation hub in Boston. The A round was led by Vivo Capital and Novo Holdings A/S. 

Trials and Approvals 

Suzhou CStone Pharma (HK: 2616) reported that its anti-PD-L1 mAb met its primary endpoint in a Phase III trial in patients with stage III NSCLC (see story). Data from a planned interim analysis showed sugemalimab patients experienced a statistically significant and clinically meaningful improvement in progression-free survival. CStone plans to submit an NDA for China approval of sugemalimab in stage III NSCLC. The company will collaborate with Pfizer to commercialize sugemalimab in mainland China, and it out-licensed ex-China rights for the candidate to EQRx.  

Shanghai AffaMed Therapeutics was approved to start a China Phase IIb trial of its Parkinson's Disease candidate (see story). AM006 is a novel non-ergot dopamine agonist that acts by stimulating striatal dopamine receptors. Because AM006 has a higher affinity for dopamine receptors, and more balanced activation of D2 and D3 receptors, it is expected to show fewer side effects than other members the dopamine agonist class. In  2020, AffaMed acquired Greater China rights to the candidate from Kissei Pharma, a Japanese company. AffaMed will join the global Phase IIb trial of the molecule.  

Suzhou Innovent (HK: 01801) has dosed the first patients in a China Phase III trial of pemigatinib, a fibroblast growth factor receptor 1/2/3 inhibitor, in patients with cholangiocarcinoma (see story). The clinical test is the China arm of a global Phase III trial that compares the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin as a first-line therapy for advanced cholangiocarcinma with a FGFR2 rearrangement. In 2018, Innovent acquired greater China rights to the candidate from Incyte (NSDQ: INCY) as part of a $390 million, three-drug deal.  

Transcenta, a Suzhou biotherapeutics company, reported positive results from a Phase I trial of its pH-dependent PD-L1 antibody in pre-treated solid tumor and lymphoma patients (see story). Of the 17 solid tumor patients who could be evaluated for efficacy via biomarkers, 35% had a confirmed partial response at the low dose and 44% at the high dose. The trial did not find any dose limiting toxicities. Transcenta presented the data as an abstract online publication at the 2021 Annual Meeting of the American Society of Clinical Oncology.  

Sinovant Sciences, a Shanghai biopharma, reported positive topline results from its Phase III bridging study of lefamulin in China adults with community acquired bacterial pneumonia (CABP) (see story). The trial showed lefamulin was non-inferior to IV/oral moxifloxacin in patients with CABP. In 2017, Sinovant acquired China rights to the anti-infective from Nabriva, a Vienna company, in a $95 million agreement. Sinovant will transfer the China rights for lefamulin to Sumitomo Pharma (Suzhou) along with rights to three other Sinovant candidates.  

TransThera, a clinical stage Nanjing biopharma, will partner with Roche to test a combination therapy for China patients with gastrointestinal tract cancers (see story). The companies will conduct a trial of TransThera's TT-00420 and Roche's anti-PD-L1, Tencentriq (atezolizumab). TT-00420 is novel small molecule kinase inhibitor. In a Phase I trial it showed preliminary clinical benefits in Cholangiocarcinoma patients and other GI cancer patients. It also appears to modulate the tumor microenvironment, which makes it an attractive partner for checkpoint inhibitors in hard-to-treat solid tumors.  

Hangzhou's Ascletis Pharma (HK: 1672) reported that China has accepted for review the company's filing for a clinical trial of a brain cancer treatment (see story). Ascletis intends to test a combination of ASC40 and bevacizumab in patients with recurrent glioblastoma (rGBM). ASC40 is an oral small molecule inhibitor of fatty acid synthase (FASN), a protein that regulates lipid metabolism and is present in many cancers. In 2019, Ascletis acquired China rights to the candidate from San Francisco's 3-V Biosciences for NASH.  

HitGen (SHA: 688222) of Chengdu will collaborate with Dorian Therapeutics, a Bay Area biotech, to develop senoblockers, a new drug class designed fight aging by rejuvenating cells and tissues (see story). Dorian's senoblockers act on epigenetic regulators to reverse the decrease in stem cell activity that slows cell regeneration in older people. This causes senescent cells to accumulate in the body and poison tissues. HitGen will use its DNA-encoded library platform to discover compounds that bind targets chosen by Dorian. HitGen will receive an upfront payment plus milestone payments from Dorian.  

South Korea's Hyundai Bioscience (KOSDAQ: 048410) reported that its niclosamide (NIC) oral treatment for COVID-19 increased the sustained bioavailablity of the API (see story). In an animal test, CP-COV03 brought the viral inhibition (IC50) level of niclosamide up to 300 times the IC50 level and maintained the level at or above IC50 for 24 hours. Although niclosamide is recognized as a potential treatment for antiviral drugs, it has poor oral availability in its natural state. A Hyundai subsidiary, CNPharm, will test CP-COV03 in humans.  

Disclosure: none.