S.Korea's GL Rapha to ship out 10 mln Sputnik Light COVID-19 shots this month

Boryung

14/09/2021 06:07

By Sangmi Cha
    SEOUL, Sept 14 (Reuters) - South Korean biotech firm GL
Rapha expects to win regulatory approval from Russia to export
Sputnik Light coronavirus vaccines this month, its chairman
said, paving the way for the first overseas production of the
shot to ease a supply shortage.
    The Russian Direct Investment Fund (RDIF), which markets
Sputnik V and single-dose version Sputnik Light abroad, plans to
produce around 700 million doses overseas this year.
 urn:newsml:reuters.com:*:nL1N2MS168
    But production got off to a slow start and growing domestic
demand constrained supply from Russia, disrupting both shots'
global rollout plan and allowing rival vaccine makers to fill
the gap in several markets.  
    "Everything is pretty much ready and we continue to produce
the vaccine as we wait for Russia to validate our production
process," GL Chairman Whang Jae-gan said in an interview.
    He said the RDIF, the Russian sovereign wealth fund, had
informed the firm that approval was expected later this month,
and it is preparing a joint ceremony to mark the first overseas
vaccine production and shipment.
    RDIF declined to comment.
    GL, which oversees the entire production of the vaccine from
drug substance to packaging in its facility in Chuncheon, east
of Seoul, has at least 10 million doses of Sputnik Light already
in storage ready for shipment pending approval.
    It comes more than a year after the two sides first started
cooperation talks, which accelerated following technology
transfer by its Russian developer Gamaleya Research Institute in
October, underscoring the complicated process facing global
efforts to rapidly boost vaccine supply.
    "We needed to act decisively and decided to put all our
resources into it," Whang said, adding he was encouraged by
confidential clinical data presented to it even before a deal
was agreed.
    He said the company suspended all other drug production, and
boosted efforts to scale up and generate synergies.
    In April, just six months after the technology transfer, GL
sent out a validation batch for Sputnik V, and around the same
time the RDIF also asked the company to produce Sputnik Light
concurrently. GL is now awaiting a Good Manufacturing Practice
(GMP) nod from Russia for its production facility.
    The company has scaled up production far exceeding its
initial target of 650 million doses per year through its
consortia that include botox-maker Jetema Corp  216080.KQ , CKD
BiO Corp  063160.KS , Hankook Korus Pharm, and Boryung
Biopharma, a vaccine manufacturing arm of Boryung Pharm
 003850.KS , Whang said.
    He declined to elaborate on exact capacity.
    While the RDIF will decide which nations get the vaccine
first, it's likely to be sent to various countries that have
reported delays, Whang said.
    Production is also set to accelerate elsewhere, with Serum
Institute of India planning to manufacture trial batches from
this month.  urn:newsml:reuters.com:*:nL8N2OP23U
    Six Indian companies have already signed deals to produce
around 1 billion doses of Sputnik V annually.  urn:newsml:reuters.com:*:nL2N2NL0IB

 (Reporting by Sangmi Cha; Additional reporting by Anton Zverev
in Moscow; Editing by Miyoung Kim & Shri Navaratnam)
 ((sangmi.cha@thomsonreuters.com;))