Week In Review: OrbiMed Plans To Raise $1.1 Billion For Fifth Asia Fund

Laboratory Test Tubes

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Deals and Financings

One year after raising $3.5 billion for three funds in 2021, OrbiMed, the world’s largest healthcare-dedicated investor, is back with plans for $4.75 billion in new funds despite the slowdown in biopharma exits over the past year (see story).

OrbiMed Asia V plans to raise $1.1 billion, OrbiMed Flagship IX seeks $1.9 billion, and OrbiMed Royalty & Credit Opportunities is looking toward $1.75 billion. Before the new rounds, OrbiMed already had $15 billion in assets under management that was spread over 500 healthcare companies. 

Shanghai Hansoh Pharma (3692.HK) announced a $218 million agreement to acquire Greater China rights for a small molecule oncology candidate developed by NiKang Pharma of Delaware (see story). NiKang is currently conducting a US Phase I/II dose escalation and expansion trial of NKT2152, a small molecule drug that inhibits HIF2α, in patients with clear cell renal cell carcinoma.

Hansoh will pay $15 million upfront and up to $203 million in milestone payments, plus royalties. It’s the second partnership between the two companies: two years ago, Hansoh in-licensed greater China rights to a small molecule anti-viral candidate from NiKang in a $100 million deal. 

Shanghai Jemincare Pharmaceuticals out-licensed global rights (ex-China) for a novel pain medication to Orion Corporation, a Finnish pharmaceutical company (see story). Jemincare was recently approved to start a China Phase I trial of the selective NaV 1.8 blocker for acute and chronic pain. NaV 1.8 is a sodium channel subtype that modulates the excitability of pain fibers.

Although NaV 1.8 has been shown to play a pivotal role in pain transmission, there are no approved drugs for the target currently. Orion will make a $16 million upfront payment for the rights, plus unspecified milestones and 8%-15% royalties on sales. 

Beijing Zhifei Lvzhu Biopharma in-licensed China rights to a whooping cough vaccine developed by Intravacc of the Netherlands. Intravacc used its outer membrane vesicles (OMV) platform to develop Avacc 3 (see story). OMVs are spherical particles that can be rigged with immunogenic peptides and/or proteins that stimulate effective adaptive immunity. 

Intravacc says Avacc 3, a homologous Bordetella pertussis candidate vaccine based on the OMV platform, induces a strong systemic immune response. If it is administrated intranasally, it induces both a strong systemic and a strong mucosal immune response. 

Trials and Approvals

BeiGene (BGNE) announced China approval for Blincyto® (blinatumomab) to treat pediatric patients with leukemia (see story). In 2020, China’s NMPA approved Blincyto® for adult leukemia patients. BeiGene acquired rights to the candidate from Amgen (AMGN) as part of a $2.7 billion deal signed in 2019 that included China rights to 23 Amgen oncology drugs.

BeiGene is responsible for developing the drugs in China (many of them pre-clinical), and Amgen acquired a 20% stake in BeiGene. In its latest approval, Blincyto® is indicated in China to treat pediatric patients with relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia. 

Stressing the positive, Shanghai Junshi Biosciences (1877.HK) and its US partner, Coherus Bio (CHRS), were not daunted by a US rejection of the BLA for their partnered PD-1 to treat nasopharyngeal carcinoma (NPC) (see story).

The companies said the US FDA asked for a quality process change that is “readily addressable,” and they hope to resubmit the NDA by mid-summer. The major difficulty is scheduling an onsite inspection, given China’s COVID-19 restrictions. In 2021, Junshi out-licensed US/Canada rights for the PD-1 to Coherus in a $1.1 billion deal. 

Shanghai Newsoara Biopharma has been cleared to proceed with its China Phase III trial of LB1148, which is designed to accelerate the return of bowel function in adult patients following bowel/abdominal surgery (see story). The candidate is an oral broad-spectrum serine protease inhibitor that is aimed at neutralizing digestive proteases released from the gut during surgery.

Newsoara in-licensed greater China rights to the drug from Palisade Bio (PALI) of Carlsbad, CA, which recently announced US approval of a similar Phase III trial. Newsoara is a Shanghai in-licensing company with an R&D facility in Suzhou BioBay. 

Suzhou Kintor Pharma (9939.HK) dosed the first patient in a US Phase II trial of its ALK-1 antibody in combination with Opdivo (nivolumab) to treat advanced Hepatocellular Carcinoma (see story). Kintor believes the ALK-1 antibody is a potential first-in-class, fully human IgG2 neutralizing mAb. It inhibits BMP9, TGFβ through ALK-1 receptor-mediated signal transduction and tumor angiogenesis.

In 2018, Kintor acquired global rights to the ALK-1 antibody from Pfizer. The Phase II trial will enroll 105 patients who were intolerant of checkpoint inhibitors or progressed after a first-line round of checkpoint therapy. 

Connect Biopharma (CNTB), a Taicang-San Diego inflammatory disease company, reported disappointing results from a US Phase II trial of an S1P inhibitor in patients with ulcerative colitis (see story). Connect said it will look for a partner to take over further clinical trials of the drug.

In the trial, CBP-307 did not provide a statistically significant improvement over other S1P inhibitors. CBP-307 is an oral small molecule designed to modulate sphingosine 1-phosphate receptor 1. Connect’s lead candidate, CBP-201, is an antibody that targets interleukin-4 receptor alpha IL-4Rα currently in a Phase III trial for atopic dermatitis and asthma. 

Shanghai Inmagene Biopharmaceuticals was approved to start US trials of an OX40 mAb that targets immune diseases including atopic dermatitis (see story). Inmagene is developing IMG-007 in partnership with HutchMed (HCM) and has an exclusive option to in-license the candidate.

In 2021, Inmagene in-licensed global rights to four novel pre-clinical immunological candidates from HutchMed in a $920 million deal. The two companies partner pre-clinical development, while Inmagene is responsible for global clinical trials. IMG-007 is designed to inhibit binding of OX40 to OX40L reducing T cell release. 

Disclosure: None

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