Deals and Financings

Fosun Pharma (SHA: 600196; HK: 02196) is one of the finalists in a $2 billion bidding war to acquire part of Novartis' (NYSE: NVS) US portfolio of generic drugs (see story). Novartis is auctioning off US rights to lower-margined members of its Sandoz generic portfolio while it keeps the more profitable generics. India's Aurobindo, US-based Apollo Global Management and CVC Capital Partners, a Europe-Asia PE firm, have also been asked to submit final offers. Novartis' dermatology assets are included in the package.  

China Resources Pharmaceutical Group (HK: 3320) is in talks to pay $613 million for a controlling stake in Jiangzhong Group (SHA: 600750), the country’s fifth largest maker of traditional Chinese medicines (see story). Jiangzhong, which is 42% owned by the Jiangxi provincial government, owns a 43% stake in Shanghai-listed Jiangzhong Pharma, a company with a market capitalization of $1.2 billion. Both CR Pharma and Jiangzhong are State-Owned enterprises, and the transaction, if completed, would help to consolidate/reform China's network of state-owned drugmakers.  

WuXi Biologics (HK: 2269) will build a $240 million CDMO facility in Shijiazhuang, the capital of China's northern Hebei province (see story). The new facility is an addition to WuXi Biologics' existing CDMO facilities in Shanghai and a $392 million biologics CDMO facility in Ireland, announced last month. WuXi said the Shijiazhuang facility, which will employ 1,000 people, will be operational in 2020.  

Tonghua Dongbao Pharma (SHA: 600867) acquired China rights to two diabetes treatments from Adocia (Paris: ADOC) of Lyon, France in an agreement worth up to $135 million (see story). Dongbao will have rights to BioChaperone^® Combo, a fixed-ratio insulin glargine and insulin lispro combination, plus BioChaperone^® Lispro, an ultra-rapid insulin. Adocia's BioChaperone platform uses polymers, oligomers and small organic compounds to protect proteins from degradation. Dongbao already has a portfolio of diabetes treatments.  

San Diego's Ansun Biopharma closed a $85 million Series A financing round from a group of China investors (see story). Ansun is developing novel broad spectrum anti-viral biologic therapeutics that treat severe viral respiratory tract infections. Ansun will use the money for a Phase III trial of its parainfluenza treatment in immuno-compromised patients. The Series A round was led by Sinopharm Healthcare Fund and Lilly Asia Ventures.

HiFiBiO Therapeutics, a Boston company developing therapeutic immune modulators, closed a $37.5 million Series B financing led by two China investors, Sequoia Capital and Lyfe Capital (see story). According to HiFiBiO, it discovers molecules based on single-B-cell screening and analysis. The company said the funding would transform HiFiBiO into a more mature biopharmaceutical company, with a stronger global presence and rich pipeline of novel antibodies for cancer and autoimmune disorders.

Changshan Biochemical Pharma (SHZ: 300255) signed a $9.5 million deal to commercialize an osteoarthritis treatment in China developed by Israel's Kitov Pharma (NSDQ: KTOV) (see story). Changshan will have exclusive rights to import, manufacture and distribute Consensi™ in greater China. A combination drug, Consensi consists of two FDA-approved drugs: Celebrex®, a non-steroidal anti-inflammatory COX-2 inhibitor for osteoarthritis pain, and Norvasc®, a calcium channel blocker that lowers blood pressure, which is often a side effect of osteoarthritis drugs.

Jiangsu Ambition Medical has in-licensed China rights to a prostate treatment that is delivered via an injected depot system, which administers the drug directly to the tumor for up to six months (see story). Sweden's Lidds AB developed Liproca® Depot and is currently conducting a Phase IIb trial in Finland and Canada. Ambition will pay $1 million upfront, plus milestones and royalties for China rights. It will also be responsible for securing China regulatory approval, which may be the first approval for Liproca globally.   

Asymchem Labs (Tianjin) (SHZ: 002821) has co-founded the Innovative Drug Fund to complete in-licensings and partnerships that bring innovative western drugs to China (see story). Asymchem is a global CDMO with expertise in process development and commercial manufacturing. The company formed the IDF with SDIC Fund Management Company, Tianjin Haihe Industry Fund Management, and the Tianjin Economic Development Area Administrative Commission.  

Trials and Approvals

Innovent Biologics of Suzhou reported strong preliminary results from a China Phase II trial of its PD-1 candidate, sintilimab (IBI308) (see story). In 96 patients with relapsed/refractory classical Hodgkin Lymphoma, sintilimab produced an overall response rate of 79% and a disease control rate of 98%, meeting the endpoints of the study. Innovent said it submitted an NDA to the CFDA for sintilimab on April 19, 2018, which will be reviewed following speeded-up Priority Review rules.  

BeiGene (NSDQ: BGNE), a Beijing oncology company, has enrolled the first patient in a China Phase III trial of pamiparib (BGB-290), a PARP inhibitor, in patients with platinum-sensitive recurrent ovarian cancer (see story). The drug will be administered as a maintenance therapy in patients whose ovarian cancer has recurred. Pamiparib is also being tested as a monotherapy and in combination regimens for a variety of solid tumor malignancies. BeiGene pointed out that, to date, there are no PARP inhibitors approved for China use.

CStone Pharma of Suzhou has dosed the first patient in a Australian Phase I clinical trial of CS1003, an anti-programmed death-1 (PD-1) candidate aimed at solid tumor cancer (see story). CS1003 is the third CStone molecule to begin clinical testing, joining CS1001 (PD-L1) and CS1002 (CTLA-4). Because CS1003 is cross-reactive with human and mouse PD-1, it allows pre-clinical proof of concept experiments on novel targets. CStone hopes to use the pre-clinical tests to discover and then clinically substantiate first-in-combination efficacy for its checkpoint inhibitors.  

Government and Regulatory

According to reports, China plans to increase patent protection on innovative drug to 25 years, up from the current 20 years (see story). It isn't clear whether the increase will affect only drugs that file after the new rule goes into effect, or whether the increase will also be applied retroactively to products that have already filed for patent protection. The change is widely thought to be aimed at the new US tariffs on China goods. The trade war stems from US allegations that China does not respect international standards for intellectual property protection.

Disclosure: none.