药格局YaoGeJu

药格局 YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

2022/09/06 – 2022/09/12

Period
2022/09/06 to 2022/09/12, 7 days inclusive
Data as of
2026/11/08 06:00
Cached records
94,440 acceptance records, 11,586 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
290
Drugs with new generic filings (by drug name, de-duplicated)
40
Accepted this week, now under review
0

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Drug and company names link to detail pages; sign in to view them.

New acceptances this week

By application type and drug type

290filings, 56 of them generic

By application type

Application typeFilings
Supplement143
Generic56
New drug38
Import30
Unspecified15
Import re-registration8

By drug type

Drug typeFilings
Chemical drug201
治疗用生物制品46
TCM39
预防用生物制品3
Biologic1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

40 drugs with new generic filings; top 10 listed

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

154 companies with new acceptances; top 10 listed

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

85 this week

AcceptedDrugApplicants
2022/09/10Import · Class 1 利特昔替尼胶囊JXHS2200081 Pfizer Inc.; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd.
2022/09/10Import · Class 2.4 达格列净片JXHS2200080 AstraZeneca AB; AstraZeneca Pharmaceuticals LP; AstraZeneca Investment (China)Co. Ltd.
2022/09/10Import · Class 2.4 达格列净片JXHS2200079 AstraZeneca AB; AstraZeneca Pharmaceuticals LP; AstraZeneca Investment (China)Co. Ltd.
2022/09/10Import · Class 1 KIN-3248片JXHL2200284 Kinnjiu Biopharma Limited; PPC China Corporation Limited
2022/09/10Import · Class 1 KIN-3248片JXHL2200283 Kinnjiu Biopharma Limited; PPC China Corporation Limited
2022/09/10Import · Class 1 KIN-3248片JXHL2200282 Kinnjiu Biopharma Limited; PPC China Corporation Limited
2022/09/10Generic · Class 3 阿立哌唑口服溶液CYHS2201507 锦州奥鸿药业有限责任公司
2022/09/10Generic · Class 3 阿立哌唑口服溶液CYHS2201506 锦州奥鸿药业有限责任公司
2022/09/10Generic · Class 3 注射用盐酸头孢替安CYHS2201505 齐鲁安替制药有限公司
2022/09/10Generic · Class 3 注射用盐酸头孢替安CYHS2201504 齐鲁安替制药有限公司
2022/09/10Generic · Class 3 注射用盐酸头孢替安CYHS2201503 齐鲁安替制药有限公司
2022/09/10Generic · Class 3 帕拉米韦注射液CYHS2201501 河北天成药业股份有限公司
2022/09/10Generic · Class 3 帕拉米韦注射液CYHS2201500 河北天成药业股份有限公司
2022/09/10New drug · Class 1 Y101DCXSL2200456 武汉友芝友生物制药股份有限公司
2022/09/10New drug · Class 1 注射用YL202CXSL2200455 苏州宜联生物医药有限公司
2022/09/10New drug · Class 2.2 BH009注射液CXHL2200668 珠海贝海生物技术有限公司
2022/09/10New drug · Class 1 注射用 GMDTCCXHL2200667 健尔圣(珠海)医药科技有限公司
2022/09/10New drug · Class 1 卟硒啉片CXHL2200666 上海元熙医药科技有限公司
2022/09/10New drug · Class 1 卟硒啉片CXHL2200665 上海元熙医药科技有限公司
2022/09/10New drug · Class 1 卟硒啉片CXHL2200664 上海元熙医药科技有限公司
2022/09/09Import · Class 3.1 安纳白介素注射液(预充式)JXSS2200034 Swedish Orphan Biovitrum AB (publ); Hospira Zagreb d.o.o.; SOBI Pharma (Shanghai) Company Limited
2022/09/09Import · Class 3.1 古塞奇尤单抗注射液JXSL2200163 Janssen-Cilag International NV; Xian Janssen Pharmaceutical Ltd.
2022/09/09Import · Class 3.1 注射用培重组人凝血因子ⅧJXSL2200162 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Import · Class 3.1 注射用培重组人凝血因子ⅧJXSL2200161 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Import · Class 3.1 注射用培重组人凝血因子ⅧJXSL2200160 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Import · Class 3.1 注射用培重组人凝血因子ⅧJXSL2200159 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Import · Class 3.1 注射用培重组人凝血因子ⅧJXSL2200158 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Import · Class 3.1 注射用培重组人凝血因子ⅧJXSL2200157 Baxalta US Inc.; Takeda(China) International Trading Co. Ltd
2022/09/09Generic · Class 3 葡萄糖酸钙氯化钠注射液CYHS2201498 回音必集团抚州制药有限公司; 回音必集团江西东亚制药有限公司
2022/09/09Generic · Class 3 葡萄糖酸钙氯化钠注射液CYHS2201497 回音必集团抚州制药有限公司; 回音必集团江西东亚制药有限公司

55 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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