Walvax Biotechnology Co., Ltd.

Another Covid-19 study is hitting the breaks as a Swiss biotech is pausing its Phase II trial in patients hospitalized with Covid-19. Kinarus Therapeutics announced on Friday that the Data and Safety Monitoring Board (DSMB) has reviewed the company’s Phase II study for its candidate KIN001 and has recommended that the study be stopped. According to Kinarus, the DSMB stated that there was a low probability to show statistically significant results as the number of Covid-19 patients that are in the hospital is lower than at other points in the pandemic. “As many of our peers have learned since the beginning of the pandemic, it has become challenging to show the impact of therapeutic intervention at the current pandemic stage, given the disease characteristics in Covid-19 patients with severe disease. Moreover, there are also now relatively smaller numbers of patients that meet enrollment criteria, since fewer patients require hospitalization, in contrast to the situation earlier in the pandemic,” said Thierry Fumeaux, Kinarus CMO, in a statement . Fumeaux continued to state that the drug will still be investigated in ambulatory Covid-19 patients who are not hospitalized, with the goal of reducing recovery time and the severity of the virus. The KIN001 candidate is a combination of the small molecule inhibitor pamapimod and pioglitazone, which is currently used to treat type 2 diabetes. The news has put a dampener on the company’s stock price $KNRS.SW , which is down 22% since opening on Friday. While Moderna and Pfizer/BioNTech’s mRNA shots to counter Covid-19 have dominated supplies worldwide, a Chinese-based mRNA developer and IndoVac, a recombinant protein-based vaccine, was created and engineered in Houston, Texas by the Texas Children’s Hospital Center for Vaccine Development vaccine is finally ready to head to another nation. Walvax and Suzhou Abogen’s mRNA vaccine, dubbed AWcorna, has been approved for emergency use for adults 18 and over by the Indonesian Food and Drug Authority. “This is the first step, and we are hoping to see more families across the country and the rest of the globe protected, which is a shared goal for us all,” said Walvax Chairman Li Yunchun, in a statement . According to Walvax, the vaccine is 83% effective against the “wild-type” of SARS-CoV-2 infection with the strength against the Omicron variants standing at around 71%. The shots are also not required to be stored in deep freeze conditions and can be put in storage at 2 to 8 degrees Celsius. Walvax and Abogen have been making progress on their mRNA vaccine for a while. Last year, Abogen received a massive amount of funding as it was moving the candidate forward. However, while the candidate is moving forward overseas, it’s still finding itself stuck in regulatory approval in China. According to a report from BNN Bloomberg, China has not approved any mRNA vaccines for domestic usage. Meanwhile, PT Bio Farma, the holding company for state-owned pharma companies in Indonesia, is prepping to make 20 million doses of the IndoVac COVID-19 vaccine this year and 100 million doses by 2024. IndoVac’s primary series vaccines include nearly 80% of locally sourced content. Indonesia is seeking Halal Certification for the vaccine since no animal cells or products were used in the production of the vaccine. IndoVac successfully completed an audit from the Indonesian Ulema Council Food and Drug Analysis Agency, and the Halal Certification Agency of the Religious Affairs Ministry is expected to grant their approval soon.

With Moderna and BioNTech offering a model — in the US and Europe, respectively — for how mRNA biotechs can enjoy a meteoric rise to profit and fame with just one successful Covid-19 vaccine, a Chinese player is ready to put itself on the map. Abogen, which set a record just three months ago with a $720 million Series C, has now raised another $300 million as it prepares to file its vaccine candidate for authorization. Partnered with Walvax and China’s military, ABO-028M first entered clinical testing in the summer of 2020 and is now in Phase III trials in Mexico, Indonesia and Nepal. The company has kept itself largely secretive since being founded in January 2019 — its website is nearly entirely blank, save for an email address and a two-sentence description of the company. But one key differentiating factor appears to be greater stability of its mRNA vaccine at warm temperatures. SoftBank Vision Fund and 5Y Capital co-led the new raise, which is being branded a Series C+, and other investors include Chimera Abu Dhabi, Fortune Ocean and Mirae Asset Financial Group. As BioNTech’s jab, partnered with Fosun on development and distribution, remains in limbo in China, public health officials and regulatory authorities have been talking up the prospects of a rapid approval for a domestic shot. In an effort to speed up the anticipated rollout, Abogen and Walvax said on Monday they will enlist contract manufacturer GenScript ProBio to produce the plasmids that will go into their commercial batches. “The pandemic is still raging,” said Brian Min, CEO of GenScript ProBio. “Abogen Biosciences had launched the project since the very beginning of the outbreak of COVID-19.”

Fosun Pharma, BioNTech’s partner for its Covid-19 vaccine in China, has its sights set on another enormous vaccine market. The Shanghai-based company has bought a majority stake in Chengdu Antejin Biotech, which is developing a shot against 13 strains of pneumonia-causing bacteria, making it a subsidiary. It’s a two-part deal: On top of paying current shareholders $173.9 million (RMB 1.11 billion) in cash to grab a collective 32.52%, Fosun will merge its vaccine business, Dalian Aleph Biomedical, into the company. Aleph is valued at $454.2 million (RMB 2.9 billion). According to a filing with the HKEX , upon completion Fosun will hold about 73% of the new Antejin. CICC Kangrui was the biggest seller of shares, while Shanghai Heshi and seven individual investors also agreed to sell their shares. In wrangling control of Antejin, Fosun is wading into the campaign to challenge the dominance of Pfizer’s Prevnar 13, which is approved for infants between six weeks and five months. In late 2019, Walvax became the first domestic drugmaker to steer a pneumococcal vaccine toward approval. The multinational giants are already working with next-generation shots that can cover more strains of bacteria, with Merck’s 15-valent shot and Pfizer’s Prevnar 20 both getting the FDA nod in recent months. Antejin will be chasing those with a 24-valent pneumonia conjugate vaccine candidate. Backed by a hefty conglomerate, Fosun Pharma has always been eager to deploy its firepower in striking big-name deals and expanding its focus. Four years ago, it teamed up with Kite to bring its CAR-T therapy to China — and landed the country’s first CAR-T approval in June. Its Covid-19 licensing deal with BioNTech in early 2020 gave it rights to develop and commercialize the mRNA vaccine in China, although the shot has yet to be approved.