It’s been a big day for Jun­shi Bio­sciences as it nabs Chi­na’s first snap ap­proval for a home­grown PD-1 af­ter re­port­ed­ly clos­ing a $394 mil­lion IPO in Hong Kong.

Con­di­tion­al­ly ap­proved un­der pri­or­i­ty re­view, tori­pal­imab is in­di­cat­ed for fast-grow­ing cas­es of melanoma, ac­cord­ing to the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion.

“Clin­i­cal tri­al re­sults of this prod­uct shows that in treat­ing pa­tients with un­re­sectable or metasta­t­ic melanoma who have failed pre­vi­ous sys­temic ther­a­pies, it reach­es an ob­jec­tive re­sponse rate of 17.3%, dis­ease con­trol rate of 57.5%, and 1-year sur­vival rate of 69.3%,” the NM­PA writes in a note. “The prod­uct’s mar­ket­ing ap­proval has a pos­i­tive im­pact on the se­lec­tion of clin­i­cal drugs for can­cer pa­tients.”

With 68 check­points crowd­ing the pipeline, this is like­ly to be first of many OKs from Chi­na’s rapid­ly evolv­ing reg­u­la­to­ry agency. Da­ta provider Pharm­Cube pre­vi­ous­ly told End­points News that In­novent Bi­o­log­ics, BeiGene (Cel­gene’s part­ner) and Jiang­su Hen­grui are all be­ing tipped for a mar­ket launch in the first half of 2019.

The ap­proval, which took nine months to process and tech­ni­cal­ly goes to Jun­shi’s sub­sidiary TopAl­liance, fol­lows those of Op­di­vo and Keytru­da, the two pi­o­neers in the field that’s been dom­i­nat­ing sales glob­al­ly.

While the ma­jor­i­ty of Jun­shi’s IPO pro­ceeds will go to­ward the con­tin­ued de­vel­op­ment and com­mer­cial­iza­tion of PD-1, parts will fund its oth­er pro­grams, in­clud­ing a PC­SK9 drug and a Hu­mi­ra biosim­i­lar, ac­cord­ing to an ear­li­er fil­ing.

Pric­ing at the bot­tom of the range, Jun­shi are sell­ing their shares at $2.48 (HK$19.38) each, Reuters re­port­ed. It’s set to be­gin trad­ing on De­cem­ber 24.

CI­CC is the sole spon­sor for the float while Cred­it Su­isse acts as a joint bookrun­ner.

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.

Back at the beginning of 2015, Deerfield Management co-led a $10 million Series C for a private gene therapy startup, reshaping the company and bringing in new leaders to pave way for an IPO just a year later.

Fast forward four more years and the startup, AveXis, is now a subsidiary of Novartis marketing the second-ever gene therapy to be approved in the US.

For its part, Deerfield has also grown more comfortable and ambitious about the nascent field. And the investment firm is now putting down its biggest bet yet: a $1.1 billion contract development and manufacturing facility to produce everything one needs for cell and gene therapy — faster and better than how it’s currently done.

Different therapeutic traits brandished by the three approved therapies for sickle cell disease all extend life expectancy, but their impact on quality of life is uncertain and their long-term cost-effectiveness is not up to scratch according to the thresholds considered reasonable by ICER, the non-profit concluded in a draft guidance report on Thursday.

Sickle cell disease (SCD), which encompasses a group of inherited red blood cell disorders that typically afflict those of African ancestry, impacts hemoglobin — and is characterized by episodes of searing pain as well as organ damage.