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首款國產HPV疫苗低價上市!一針難求局面有望改觀
2020-01-06 23:20  www.phpfang.com

[摘要]曾在上海時疾病預防控制中心任職15年的疫苗行業專家陶黎納在1月2日接受時代財經采訪時表示,"此次國內這款二價宮頸癌疫苗的上市具有里程碑的意義。"

Taurina, a vaccine industry expert who served at the Centers for Disease Control and Prevention in Shanghai for 15 years, said in an interview with Time Financial on Jan. \"

近日,國家藥品監督管理局發布公告稱,批準廈門萬泰滄海生物技術有限公司(以下稱“萬泰公司”)的雙價人乳頭瘤病毒疫苗(大腸桿菌)(商品名:馨可寧)上市注射申請。

Recently, the state drug administration issued an announcement that approved xiamen wantai sea biotechnology co., ltd.(hereinafter referred to as \"wantai company \") dual-valent human papillomavirus vaccine (escherichia coli)(trade name: xin koning) market injection application.

據悉,該疫苗為萬泰公司與廈門大學聯合研發,由萬泰實施轉化的首款國產宮頸癌疫苗,意味著中國宮頸癌疫苗結束只能依賴進口的歷史。

The vaccine, the first domestic cervical cancer vaccine to be converted by wantai, a joint venture between wantai and xiamen university, means china's history of having to rely only on imports.

目前,宮頸癌已成為全球女性中第三大常見癌癥。隨著大眾預防宮頸癌意識的日漸普及,宮頸癌疫苗需求日益增加,全球一年的需求量高達一億支。但由于技術受限且生產宮頸癌疫苗的企業較少,目前全球供應能力僅為3000萬支,不及總需求量的三分之一。資料顯示,全球每年新發病例接近60萬人,每年有超過30萬名婦女死于這種疾病。在中國,宮頸癌每年新發病例約為15萬,死亡人數約萬,約占全部女性惡性腫瘤死亡人數的%。

At present, cervical cancer has become the third most common cancer among women in the world. With the increasing popularity of cervical cancer prevention awareness, the demand for cervical cancer vaccine is increasing, and the global demand is up to 100 million a year. But with limited technology and fewer companies producing cervical cancer vaccines, the global supply capacity is now just 30 million, less than a third of total demand. Almost 600,000 new cases are reported worldwide each year, with more than 300,000 women dying from the disease each year. In China, the number of new cases of cervical cancer is about 150,000 a year, and the number of deaths is about 10,000, accounting for about% of all deaths from malignant tumors in women.

目前,中國約有4億人需要接種HPV疫苗。時代財經梳理中國食品藥品檢定研究院統計的數據發現,2018年國內HPV簽發量為700萬支,2019年接近900萬支。若按照每人全程需注射3針疫苗計算,目前疫苗供應量還遠遠無法滿足國內市場所需,以至于出現一針難求、搖號打針的情況。

At present, about 400 million people in China need to be vaccinated against HPV. Time Finance combed the statistics of the China Institute of Food and Drug Control and Research found that in 2018, the number of domestic HPV issuance was 7 million, and in 2019 it was close to 9 million. At present, the supply of 3 injections per person is far from meeting the needs of the domestic market, resulting in a hard-to-find, rocking situation.

在萬泰HPV疫苗正式獲批前,全球已上市的HPV疫苗有3種,分別是英國葛蘭素史克公司生產的針對HPV16、18型的雙價疫苗,美國默沙東公司生產的針對HPV6、11、16、18型的四價疫苗和針對HPV6、11、16、18、31、33、45、52、58型的九價疫苗。

Before the approval of the Wantai HPV vaccine, there were three global HPV vaccines, the two-valent vaccine for HPV16 and 18 produced by GlaxoSmithKline, the four-valent vaccine for HPV6,11,16,18 and the nine-valent vaccine for HPV6,11,16,18,31,33,45,52 and 58.

其中,二價HPV疫苗對2種高危型HPV病毒(HPV-16和HPV-18)有保護作用,而中國人群中超過8成的宮頸癌由這兩種病毒引起。

Among them, the bivalent HPV vaccine protects against two high-risk HPV viruses (HPV-16 and HPV-18), and more than 80% of cervical cancer in the Chinese population is caused by these two viruses.

曾在上海時疾病預防控制中心任職15年的疫苗行業專家陶黎納在1月2日接受時代財經采訪時表示,從理論上來講,二價和四價疫苗的預防率為84%,九價疫苗預防率為92%。“雖然大眾普遍認為九價疫苗比二價和四價在預防宮頸癌上效果好很多,但有證據表明,三者在實際效果上并沒有明顯區別。”

In theory, the prevention rate of bivalent and tetravalent vaccines is 84 percent, and the nine-valent vaccine prevention rate is 92 percent, said Taurina, a vaccine industry expert who served at the Centers for Disease Control and Prevention in Shanghai for 15 years in an interview with Time Finance on Jan. \"Although it is widely accepted that the nine-valent vaccine is much better than bivalent and tetravalent in preventing cervical cancer, there is evidence that the three are not significantly different in practical terms.

另外,廈門大學公共衛生學院副院長張軍曾接受媒體采訪時表示,相較于葛蘭素史克公司的二價HPV疫苗使用昆蟲細胞生產體系,以及默沙東公司的HPV使用的重組釀酒酵母生產體系,此次獲批的雙價人乳頭瘤病毒疫苗使用的是大腸桿菌生產體系,“其直接生產成本低,更利于未來產能的放大。”

In addition, Zhang Jun, vice president of Xiamen University's School of Public Health, said in a media interview that the approved double-valent human papillomavirus vaccine used an E. coli production system, which is less costly and more conducive to the expansion of future production capacity, compared with GlaxoSmithKline's two-valent HPV vaccine using insect cell production systems and the recombinant Saccharomyces cerevisiae production system used by Mercadon.

時代財經注意到,目前進口HPV疫苗的價格普遍偏高。據北京市疾控中心公布的價格,進口九價疫苗為1298元(人民幣)/針,全程費用大約在4000元左右。進口二價疫苗為580元/針,全程也需近2000元。

Time Finance noted that the current import of HPV vaccine prices are generally high. According to the price announced by the CDC in Beijing, the imported nine-valent vaccine is 1298 yuan (RMB)\/pin, and the full cost is about 4000 yuan. The imported bivalent vaccine is 580 yuan \/ needle, and the whole process also needs nearly 2000 yuan.

萬泰公司透露的信息顯示,其HPV疫苗定價為329元/針,9-14歲小齡組全程658元,大齡組全程987元。該價格約為進口二價疫苗價格的一半。

According to the company's information, its HPV vaccine is priced at 329 yuan \/ needle,9-14 years of age group full 658 yuan, older group full 987 yuan. The price is about half the price of imported bivalent vaccines.

盡管陶黎納認為此次國內二價宮頸癌疫苗的上市具有“里程碑式”的意義,但他認為,若單純從技術上來說,這款國產疫苗“只能算中規中矩,并沒有特殊的亮點。”

Despite tao lina's belief that the domestic listing of bivalent cervical cancer vaccine is a \"landmark \", he said that if purely technical, the domestic vaccine\" can only be counted as moderate, and there is no special bright spot.\"

據其介紹,葛蘭素史克公司的二價HPV疫苗運用了全新的佐劑技術,而該技術的原理曾獲得過諾貝爾獎,且在針對2種高危型HPV病毒(HPV-16和HPV-18)產生的抗體更高。陶黎納認為,目前的國產疫苗與進口疫苗相比,“并不具備關鍵性的優勢。”

GlaxoSmithKline's bivalent HPV vaccine uses a new adjuvant technology that has won a Nobel Prize for its principles and produces higher antibodies against two high-risk HPV viruses (HPV-16 and HPV-18), it said. Tao believes that the current domestic vaccine compared to imported vaccines,\" does not have a key advantage.\"

陶黎納認為,關鍵在于企業如何在國內市場推廣這款疫苗。在他看來,這款國產疫苗在一線城市的推廣較為困難,一方面較之進口疫苗,國產疫苗只具備價格上的優勢競爭力還不夠;另一方面,一線城市大眾普遍對宮頸癌疫苗的了解程度較深,且對九價疫苗更為認可。

The key, he says, is how companies promote the vaccine in the domestic market. In his view, the promotion of this domestic vaccine in first-tier cities is more difficult, on the one hand, the imported vaccine, domestic vaccine has only a price advantage competitiveness is not enough; on the other hand, the first-tier cities generally know more about cervical cancer vaccine, and the nine-valent vaccine is more recognized.

但他認為,相較于一線城市,二、三線城市的受眾相對會更容易接受國產疫苗,“如果部分地區政府采購政策可以實現,那國產疫苗大概率會成為政府優先考慮的對象。”

But he argues that second- and third-tier cities will be more receptive to home-made vaccines than first-tier cities,\" if some regional government procurement policies can be achieved, then the high probability of home-made vaccines will be a priority for the government.\"

據最新研究發現,青少年群體只需注射一劑宮頸癌疫苗也可以達到預防效果。在注射次數少、價格減少的情況下,國內實現青少年免費接種的概率也會進一步加大。有業界人士認為,在眾多發達國家已將宮頸癌疫苗納入免費接種的行列的背景下,中國實現該類疫苗的免費接種或只是時間的問題。

The latest study found that a single dose of cervical cancer vaccine could be used to prevent the disease. In the case of fewer injections and lower prices, the probability of achieving free vaccination for adolescents in China will be further increased. Industry insiders believe it is only a matter of time before a vaccine for cervical cancer is given free of charge in china, in a context where many developed countries have included it.

時代財經注意到,2019年9月9日,萬泰公司已與葛蘭素史克共同簽署了一項合作協議,雙方將基于萬泰公司的創新抗原技術與葛蘭素史克的佐劑系統聯合研發新一代的人乳頭瘤病毒疫苗。

Time notes that on September 9,2019, Wantai has signed a cooperation agreement with GlaxoSmithKline to jointly develop a new generation of human papillomavirus vaccine based on Wantai's innovative antigen technology with Glaxo's adjuvant system.