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Chi­na green­lights home­grown pneu­mo­coc­cal, HPV vac­cines for the mar­ket — break­ing grips by Pfiz­er, Mer­ck

Pfizer’s dominating pneumococcal vaccine Prevnar 13 finally has a rival — and it’s neither Merck nor any of the small biotechs trying to topple the megablockbuster.

China has approved a pneumococcal 13-valent conjugate vaccine developed by a unit of Walvax Biotechnology, as an alternative option mainly for infants and children 6 weeks to 5 years old. On the same day, regulators also announced they have OK’d Cecolin, an HPV vaccine for women aged 9 to 45 developed by Xiamen Innovax.

Jiankui He at the International Summit on Human Genome Editing, November 2018. (AP Images)

Chi­nese court sen­tences Jiankui He to 3 years in jail — and con­firms birth of 3rd CRISPR ba­by

A year after shocking the world with the revelation that the world’s first CRISPR gene edited babies had been born, Jiankui He is going to jail for three years.

The initial trial found He — a former professor at the Southern University of Science and Technology in Shenzhen who hadn’t been seen publicly for months — guilty of illicitly practicing medicine alongside two other researchers who assisted him in “illegally executing human embryo editing and reproductive medical activities with reproductive purposes,” according to state news agency Xinhua. The trio were also fined about $640,000 (RMB$4.5 million) collectively.

Bank­ing on Shang­hai's biotech boom, this Eli Lil­ly-backed play­er grabs $100M to push next-gen I/O ther­a­pies

Every six months for the past two years or so, five renowned scientists and biotech vets — David Shen of NGM Bio, Arlene Sharpe and Vijay Kuchroo of Harvard, Juno co-founder Phil Greenberg and University of Chicago’s Tom Gajewski — would meet. There (most recently at Napa Valley over wine), as a scientific advisory board, they would offer advice to a biotech startup based an ocean away in Shanghai, on their quest to uncover new targets and new antibody therapeutics for immuno-oncology.

Alan List. Tianjin Medical University Cancer Institute and Hospital

NIH-di­rect­ed purge of re­searchers with Chi­na ties sweeps up Mof­fitt CEO Alan List, col­leagues

In an escalation of the already heightened sentiments around threats of academic espionage, Moffitt Cancer Center said Alan List, its president and CEO, and center director Thomas Sellers have resigned for violating conflict of interest rules through their work in China.

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BeiGene CEO John Oyler (Image: Endpoints News)

BeiGene's BTK in­hibitor fails to beat mar­ket leader Im­bru­vi­ca in key head-to-head study

BeiGene’s quest to develop a best-in-class BTK inhibitor hit a major roadblock on Monday as the company conceded that the drug failed a keenly anticipated head-to-head trial testing its recently approved drug, Brukinsa, against the market-leading Imbruvica.

The results amount to a serious setback for China’s BeiGene that is hoping to position Brukinsa, known chemically as zanubrutinib, as the best-in-class therapy.

As­traZeneca joins Mer­ck, Bris­tol-My­ers in Chi­na's check­point race as reg­u­la­tors OK first PD-L1

AstraZeneca has made a stride toward realizing its ambitions in China as regulators greenlight Imfinzi as a treatment for non-small cell lung cancer.

In particular, the PD-L1 agent is filling a void for immunotherapies in Stage III unresectable case, the company said, where the cancer has not spread to the rest of the body. It is to be used, with curative intent, in patients whose cancer hasn’t progressed following concurrent platinum-based chemotherapy and radiation therapy.

Al­pham­ab On­col­o­gy rounds out HKEX's sec­ond biotech IPO year with $230M raise and high lo­cal in­ter­est

Alphamab Oncology has inspired a surge of local interest in what will likely be the Hong Kong Stock Exchange’s last biotech run of the year, pricing its IPO on the high end of the range and raising over $230 million (HK$1.83 billion).

After rejigging the offering structure and making up to 50% available for enthusiastic local investors, the biotech sold 179.4 million shares at $1.31 (HK$10.2) and saw its stock rise to $1.77 ($13.8) on the first day of trading.

Shak­ing up Chi­na's PD-(L)1 re­im­burse­ment land­scape, In­novent, Eli Lil­ly earn cov­et­ed spot on na­tion­al cov­er­age

Innovent and Eli Lilly have claimed the first-ever spot for a PD-(L)1 inhibitor on China’s National Reimbursement Drug List — at a steep discount price that could alter the market landscape for every other checkpoint drug in the country.

Starting in 2020, Tyvyt will be available for RMB2843 ($403) per 100mg, down about 64% from its original price of RMB7838/100mg ($1117.96).

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Roche shows Tecen­triq/Avastin com­bo helps liv­er can­cer pa­tients live longer

With an eye on a swelling Chinese market, Roche unveiled Phase III data showing a combination of Tecentriq, its immunotherapy, and Avastin could help patients with the most common form of liver cancer live longer than under the standard treatment, Bayer’s Nexavar.

In a trial of 501 unresectable hepatocellular carcinoma patients, Roche’s cocktail reduced the risk of death by 42% and the risk of cancer progression by 41% as compared to Nexavar. Enough Tecentriq patients have lived long enough that Roche couldn’t yet determine the median OS but those on Nexavar passed away after a median of 10.4 months.

Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.