publication date: Apr 3, 2021
author/source: Richard Daverman, PhD
Deals and Financings
Simcere Pharma (HK: 2096) of Nanjing announced a $292 million agreement to develop a proposed Kazia Therapeutics (ASX: KZA; NSDQ: KZIA) treatment for glioma in Greater China (see story). Paxalisib is a brain-penetrant inhibitor of the PI3K/Akt/mTOR pathway, which is disordered in the majority patients with glioblastoma, the most common and most aggressive form of primary brain cancer. Kazia, an Australian company, said paxalisib seemed to be effective in a pivotal Phase II trial among GBM patients, though the trial began less than three months ago.
LianBio, a Shanghai-Princeton in-licensing company, formed a $200 million partnership with Tarsus Pharma (NSDQ: TARS) of Irvine, CA, to develop Tarsus' ophthalmology drug in Greater China (see story). Tarsus describes TP-03 as a first-in-class therapeutic in late-stage development to treat Demodex blepharitis and Meibomian Gland Disease (MGD), two eye conditions with unmet treatment needs. The company said there are 40 million China patients with Demodex blepharitis and another 70 million patients with MGD. Tarsus will receive a minority stake in LianBio Ophthalmology, a newco, if specified milestones are met.
AffaMed Therapeutics, a Shanghai biopharma, closed a $170 million Series B financing to develop treatments for ophthalmic, neurological and psychiatric disorders (see story). Formed in 2019 by CBC Group, AffaMed merged last fall with EverInsight, a Shanghai company with a similar focus. In 2019, AffaMed in-licensed its first three ophthalmology candidates from Korea's Bioepis. It will use the proceeds to advance clinical development of its pipeline, augment business development and prepare for commercialization.
Immune-Onc Therapeutics of Palo Alto, CA raised $73 million in a Series B1 and B2 financing led by Oceanpine Capital, a Beijing-based venture firm (see story). Immune-Onc is a clinical-stage cancer immunotherapy company that targets immunosuppressive myeloid checkpoints. To overcome cancer immune resistance, the company's R&D focuses on targeting the Leukocyte Immunoglobulin-Like Receptor subfamily B (LILRB) of myeloid checkpoints. Immune-Onc aims to test its candidate in blood cancers and solid tumors.
Qihan Biotechnology, a Hangzhou gene editing company, raised $67 million in a Series A++ round to advance its portfolio of novel autologous cell therapies (see story). The company uses its multiplexable genome editing technology to develop cell therapies and facilitate organ transplants. With the new capital, Qihan plans to conduct IND-enabling studies and hypoimmunity projects, plus expand its manufacturing facility. The round was backed by Lilly Asia Ventures, Matrix Partners China, Sequoia and CMB International.
Neuracle Technology (Changzhou) closed a Series B funding of $16 million to advance development of its brain-machine interface technology (see story). With its ties to Tsinghua University's technology, Neuracle is developing a minimally invasive brain-computer interface system that inserts a coin-sized internal machine in the skull. The device communicates wirelessly with an external device. The B round was led by Sequoia Capital China and included Co-win Ventures and Roton Capital.
Jiangxi Jemincare Group was approved to start US clinical trials of its SARS-CoV-2 neutralizing antibody (see story), JMB2002, which was developed by the Jemincare Shanghai Research Center. The company published data in February showing that, in preclinical studies, JMB2002 showed strong prophylactic and therapeutic efficacy against SARS-CoV-2 in rhesus macaques. In January, Jemincare started a China Phase I clinical trial of the candidate in healthy volunteers. The company is headquartered in Nanchang.
Beijing's Sinovac (NSDQ: SVA) reported that it now has the ability to manufacture two billion doses annually of CoronaVac®, its inactivated COVID-19 vaccine (see story). So far, the company has delivered 200 million doses of the vaccine to over 20 countries, including China. Sinovac believes that over 100 million doses of CoronaVac have been administered during the rollout. In 2020, Sino Biopharma (HK:1177) invested $515 million in a Sinovac subsidiary to double production of the inactivated vaccine.
Trials and Approvals
Zai Lab (NSDQ: ZLAB; HK: 9688) announced China's NMPA has approved Qinlock® (ripretinib) to launch as a treatment for advanced gastrointestinal stromal tumors (GIST) (see story). The indication is for adult patients who have received prior treatment with three or more kinase inhibitors, including imatinib. In 2019, Zai acquired China rights to Qinlock, which targets a broad spectrum of KIT and PDGFRα mutations known to drive GIST, from Deciphera (NSDQ: DCPH) in a $205 million deal.
CStone Pharma (HK: 2616) of Suzhou was approved to launch Ayvakit (avapritinib) tablets, a treatment for unresectable/metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation (see story). The NMPA approval of Ayvakit was based on an open-label Phase I/II bridging study in China patients with advanced GIST. All eight patients showed anti-tumor activity. One week ago, CStone announced China approval of a RET inhibitor for RET non-small cell lung cancer.
BeyondSpring (NSDQ: BYSI), a New York City cancer biopharma, submitted NDAs to US and China regulators of a novel prevention treatment for chemotherapy-induced neutropenia (CIN) (see story). The company combines plinabulin with granulocyte colony-stimulating factor (G-CSF), the current standard of care. BeyondSpring says G-CSF treatment is most beneficial in Week 2 after chemotherapy, leaving patients vulnerable during Week 1, the so called “neutropenia vulnerability gap” when over 75% of CIN-related clinical complications occur.
Shanghai Henlius Biotech (HK: 2696) will file for China approval of its PD-1 inhibitor after successful Phase II trials of the candidate (see story). Henlius said HLX10 met its endpoints in a Phase II trial, but it will release the data at a future medical conference. Later this year, it plans to file a China NDA for HLX10 plus chemotherapy as a first-line treatment for sqNSCLC. The Phase II trial tested HLX10 in patients with advanced microsatellite instability-high or mismatch repair-deficient solid tumors that don't respond to standard therapies.
Shanghai's Everest Medicines (HK: 1952) said it is approved to conduct a China Phase II trial of Trodelvy® in patients with cancers that have high TROP-2 expression (see story). Everest plans to enroll 180 patients with esophageal squamous cell carcinoma, gastric cancer and cervical cancer. In 2019, Everest acquired Greater China rights to Trodelvy in an agreement worth up to $835 million from Immunomedics, which was bought by Gilead (NSDQ: GILD). Last year, Everest began a registrational China Phase IIb trial of the candidate to treat metastatic triple-negative breast cancer.
Hangzhou's Ascletis Pharma (HK: 1672) announced that it will expand its focus into oncology (see story). The company was founded to bring effective hepatitis C treatments to China at an affordable price. It has accomplished that, and it now plans to combine its two in-licensed FASN inhibitors with two self-discovered anti-cancer drugs, an EGFR anti-angiogenesis candidate (bevacizumab) and a small molecule PD-1 inhibitor. Initially, it will test a combination of ASC40 and bevacizumab in patients with astrocytoma, a cancer of the brain or spinal cord.