Local giants, bions, MNC's PD-1 "Game of Thrones" climax has just begun...

The health-care negotiations are hilariously over, and PD-1 is the absolute protagonist.
In no way because it is the hottest target in the field of cancer immunotherapy, but also because around its MNC, biological upstate, old big drug companies, all the roles of the various appearances, all come out to see the skills, behind the scenes, you come to me.
their opponents hold PD-1, the health care negotiations are the test room is also a competition, win the game, rely on strength, but also need luck.
fact, the race started long before PD-1 was discovered.
the first phase of the project: "Catching the Trend" was born, and the story of the dark surge of PD-1 began in Japan in 1992.
"The discovery of PD-1 was accidental," said Yasuya Ishda, a research team member at Kyoto University in Japan who won the 2018 Nobel Prize in Physiology and Medicine.
't be sure at first.
shida himself named PD-1 (programmed death-1) with the hope that the genetic factor could play a role in the apoptosis of T cells from death.
study did not attract much attention at the time, and even the first discoverer, Jingya Shida, left the PD-1 research program the next year to go to Harvard University.
in the mid-to-late 1990s with Kyoto University, Ono was involved in the development of PD-1, but only slowly as one of the company's many compounds.
"There were a lot of compounds in the company at the time, and (PD-1) wasn't one of companies that had high hopes for research and development, " Mr. Ono's president, Xiang Liangxiao, recalled in a 2015 interview.
2002, Kyoto University and Ono Pharmaceuticals jointly filed patents for PD-1 in Japan.
Said ono had no anti-tic technology at the time, and that all 13 of Japan's capable drug companies had sought cooperation, all of which were rejected.
that these companies consider immunotherapy "untrustworthy" and that it has caused Japan's pharmaceutical industry to lose its pre-exclusive PD-1 lead.
, Ono had to look overseas, and in 2005 reached a cooperation agreement with Medarex.
2009, BMS bought Medarex for $2.4 billion, and PD-1 was included in its revenue.
PD-1 stage moved across the ocean.
cooperation has only been going on for a year.
August 2006, Medarex pushed the PD-1 antibody Nivolumab, the predecessor of O drugs, into clinical Phase I trials, with the first group of 39 patients scheduled to have cancer recurrence.
but the results were not stunning, with many people questioning PD-1 inhibitors and shaking Up Medarex's management.
2009, BMS, which acquired Medarex, continued its research with Nivolumab.
as the tracking time lengthened, surprising results gradually came to the fore.
2010, BMS announced the treatment of the first patients in Nivolumab, as if a heavy bomb had detonated quickly.
recovered the PD-1, the predecessor of the drug K, acquired by Saling-Ya from Organon in the Netherlands and was admitted to clinical trials in December 2010.
ordinary people can hardly imagine K medicine, O medicine, such a cross-era product, has been "sold", dusted.
seems to have paid a greater price in terms of the amount of the acquisition, but Mercadon's initial intention is not this PD-1.
it was not known how likely the BMS "bet" was, but the deal at one point pushed its pearl chain acquisition to the altar.
results, BMS was a little better at first.
July 2014, when BMS's O-drug was approved in Japan, Four domestic PD-1s of Hengrui Pharmaceuticals, Baiji Shenzhou, Xinda Bio and Junshi Bio had not yet been submitted to IND.
understood that the domestic PD-1 roughly began in 2012.
year, PD-1 has become one of the hottest targets in cancer treatment.
February 2012, Baiji Shenzhou launched the PD-1 research project at the Beijing Research and Development Center, code-named BGB-A317, the same year Xinda Bio's PD-1 project, research and development code IBI308.
founded in December 2012, speculated that the project would take place no earlier than 2012.
, although not announced, but from the approval progress is not known.
, the PD-1, born of catching up with the tide, was doomed from the start.
, however, these companies that develop PD-1 may have seen the future long ago and started thinking about the "future" from the beginning of research and development.
because of the late departure, Jun really started to avoid the common disease of the big adaptation certificate, but chose a small adaptation certificate - melanoma, not only avoid K medicine, O medicine, but also speed up the market speed.
Essida chose EGFR-positive drug-resistant non-small cell lung cancer, which is difficult but has no competitors.
Henrui and Baiji were prepared to grab food at low prices at low prices with K-drugs and O-drugs, and the subsequent deal gradually revealed that their ambitions might not be just at home.
in January 2015, Hengrui's PD-1 product (SHR-1210) IND application was just accepted by CDE, and in September it gave its overseas interests to Incyte for $795 million.
at that time, Hengrui's annual sales were just over $1.2 billion.
the same is true of The United States.
April 2017, Baiji just announced the launch of the first key study in China for the Reilly Pearl single resistance.
reached a strategic partnership with The New Base to jointly develop and commercialize the BGB-A317 in a deal worth up to $1.4 billion.
has completed three rounds of financing ,including a U.S. listing , with a total financing of about $320 million .
clinical progress, the four enterprises are also always catching up with each other.
From the first subject's entry date, Junshi Bio may be the first approved clinical PD-1 enterprise, Hengrui is the second, was approved in February 2016, the difference between the two may be less than a month.
september of the same year, Xinda was approved for clinical treatment, and in December, Baiji also entered clinical practice in China.
later listed, two companies that worked the adaptation certificate were the first to be approved for listing.
junshi creature's Terriple single resistance became the first domestic PD-1, Xinda's Xindili single resistance became the second, Hengrui, Bai Jishun was approved.
results, the initial strategic fit of each company has been successful.
the second stage: innovation, the giant has been in 2018 can be described as China's PD-1 development of an important watershed.
two leading products of the global PD-1 single resistance entered the Chinese market this year.
, BMS's O-drug (Navuliyu monoanti) was first listed in China, becoming the first PD-1 product to be approved for sale in China.
, on July 25, 2018, Mercadon's K-drug (Pabli-Pearl single-dose injection) was approved by NMPA to enter the Chinese market.
the two regretful pharmaceutical giants, but the Chinese market agent to Shanghai Pharmaceuticals.
according to the third quarter report of the year, Shanghai Pharmaceuticals in O and K drugs distribution revenue reached 190 million yuan and 150 million yuan, respectively, the market power can be seen.
from the O drug officially entered the Chinese market, the domestic competition on PD-1 will go to a new level.
whether it is Hengrui or Xinda, Junshi, Baiji Shenzhou are preparing for the launch of PD-1 products, the production capacity layout of many enterprises is from this stage.
waited 284 days, and on December 17, 2018, Junshi Creature finally got some good news.
the NMPA approval for its Terriple monoanti-injection as a priority review, the adaptation certificate is the same as Mercadon's K drug melanoma.
the same time, Junshi Bio launched its Shanghai Lingang production base in 2016 and completed the structural capping in October 2018.
the production base in the future is very core role is to undertake PD-1 single-resistance production.
IBI308, which lasted eight months, was officially approved on 24 December 18.
is the first major achievement of Xinda's nearly five-year partnership with Lilly and the first approved product since Thyda Bio's IPO.
the layout of Cymco's production capacity was earlier, and by the time the D-round financing was completed in November 2016, the company had built a high-end biopharmaceit industry base with a construction area of 93,000 square meters, including two 1,000-liter production lines, and plans to continue construction of four 2,000-liter and four 15,000-liter production lines.
, however, at first Thysta's capacity was not eddy for PD-1, but for CMO.
compared with Xinda and Junshi's two PD-1s, Hengrui's SHR-1210 can be described as "a lot of life."
the beginning of its research and development progress is not backward, SHR-1210 is the first to enter the third phase of clinical (April 2017) PD-1 single resistance, has been high-profile, once considered to be the most powerful to seize the first seeded players.
by the end of 2018, Hengrui was already preparing for the launch and pricing of PD-1 products, investigating patients' ability to pay, analyzing competitors' strategies, and saying externally that pricing would be lower than imports, but not much lower.
capacity, Hengrui also expanded its existing capacity of 26,500 liters to 45,940 liters.
data show that by 2018, Hengrui has invested more than $397 million in the drug.
things didn't go as expected, and in February 2018, the Company of China PD-1 failed and its partners Incyte company found another PD-1 product in October 2017.
, on the other hand, the approval of the SHR-1210 was blocked, although the application was submitted at the same time as Thyda, but the approval of the listing was nearly half a year apart.
it is understood that in the SHR-1210 listing approval, Hengrui has repeatedly supplemented the data, and at one time due to the existence of "hemangioma" (abnormal growth of capillary endoblast cells), causing industry controversy.
the last day of May 2019, Hengrui's PD-1 was approved for sale and went on sale in August.
delay could result in Karelli's single-payer missing out on 2019 health-care negotiations.
affected by the adaptation certificate and other factors, Baiji Shenzhou PD-1 was approved the latest time, at the end of December 2019, its PD-1 products were officially approved for listing through the NMPA, when the Xindili single resistance has entered the health insurance.
's production capacity layout began in 2017, and the first phase of the site was completed before the launch, with a capacity of up to 8,000 liters, all for this unseeded PD-1.
" factory was built late, not early.
," Wang Xiaodong, founder of Baiji Shenzhou, once said.
same time, Baiji Shenzhou signed a contract agreement with Bollinger Ingham in early 2018 to guarantee the production and supply of Reilly's single-resistance.
the competition over production capacity, the construction of commercial teams has gradually begun.
to support the commercialization of Xindili's single resistance, Xinhua's sales and marketing team has grown from 264 in 2018 to 688 in 2019.
Xiaobin, general manager of Baiji Shenzhou China, also joined Baiji at this stage, responsible for the construction of Baiji's commercialization team, which has so far reached more than 1,300 people.
in the domestic PD-1 riveted enough "you catch up with me", MNC level O drug commercialization team in China has been all shuffle.
including Zhao Ping, who led the listing of O-drugs in China, Guo Anfeng, head of the immuno-oncology sales team, and Luo Tianhong, head of the Chinese mainland and Hong Kong regional medicine departments, have left to join innovative pharmaceutical companies.
not just O drugs, but K's business and team are also facing a reshuffle, including the departure of Mu Yanping, who formed K's sales team.
the third stage: the market smoke has started, where to go next? With Syndilly Mono-Resistance (Dabershu) becoming the first and only PD-1 to enter the National Health Care Directory, how many "PD-1s can the industry get into" in the 2020 health care negotiations? What's the price? "The discussion has never stopped . . . Although Dabershu's price has fallen by 64%, and although only the "Hodgkin's lymphoma" single adaptation certificate has been included in Medicare payments, it is undeniable that sales have been excellent since Dabershu entered health insurance, and its sales revenue in the first half of 2020 has been equal to that of the whole of 2019.
public data show that Daboshu's cumulative sales in the first three quarters of 2020 exceeded RMB 1.5 billion, respectively, 400 million yuan, 500 million yuan and 600 million yuan, and showed a quarterly upward trend.
analysis estimates that Dabershu's annual sales will exceed 2.2 billion yuan, the effect of health care release is obvious.
that other PD-1 manufacturers said they were not envious of the results.
now, last year's Dalbershu waist-slashing price cuts did not dampen the confidence of other manufacturers PD-1 entry, this year's level of competition is still increasing.
there are currently 8 kinds of PD-(L)1 drugs in China, from the health insurance bureau previously published the first instance list, all approved for listing but not into the health insurance of the seven products, have passed the formal review.
Whether it's the "second-year student" in the health care negotiations, or the new contestants Heng Rui and Baiji who missed last year's negotiations, or the star-level K-drugs, O-pills, or the newly shortlisted T-drugs and I-drugs, are looking forward to entering the 2021 health care catalog.
, the health insurance bureau last year on Dabershu's price cut or "hands-on", this year the health insurance bureau more than the pursuit of the trend.
, for example, from the current outflow of news, Henri's Erica drop or more than 80%! The annual treatment cost is about 45,000 to 50,000 yuan.
the just-concluded negotiations, PD-1 is entering the health care era.
in the eyes of PD-1 manufacturers