YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 166 drug applications between 6 October 2021 and 12 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 29, covering 21 drug names.

2021/10/06 – 2021/10/12

Period
2021/10/06 to 2021/10/12, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
166
Drugs with new generic filings (by drug name, de-duplicated)
21
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.

Names with a public page are linked.

New acceptances this week

By application type and drug type

166filings, 29 of them generic

By application type

Application typeFilings
Supplement89
Generic29
New drug27
Import9
Unspecified8
Import re-registration4

By drug type

Drug typeFilings
Chemical drug111
Therapeutic biologic27
TCM24
Biologic4

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

21 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Parecoxib Sodium for Injection322
2阿普米司特片 · No verified English name313
3氧 · No verified English name2215
4Ornidazole Injection210
5Cyclophosphamide Capsules212
6磷酸奥司他韦干糖浆 · No verified English name210
7依托咪酯乳状注射液 · No verified English name111
8Lidocaine Cataplasms117
9Salbutamol Sulfate Inhalation Solution112
10Diquafosol Sodium Eye Drops115

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

103 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
2Jiangxi Di Kang Pharma Co., Ltd. romanized440
3Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized421
4Qilu Pharmaceutical Co., Ltd.423
5Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized410
6Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized410
7Hangzhou Minsheng Pharmaceutical Co., Ltd330
8Janssen-Cilag International NV320
9Cheng De Xin Ai Min Pharmaceutical Co., Ltd. romanized320
10Jiangsu En Hua Pharma Co., Ltd. romanized320

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

43 this week

AcceptedDrugApplicants
2021/10/12Import · Class 1 IPN60130胶囊 · No verified English nameJXHL2101198 Clementia Pharmaceuticals Inc; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/10/12Import · Class 1 IPN60130胶囊 · No verified English nameJXHL2101197 Clementia Pharmaceuticals Inc; IPSEN(SHANGHAI)INNOVATION PHARMACEUTICAL CO. LTD.
2021/10/12Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2101840 Yunnan Xian Shi Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2021/10/12Generic · Class 3 磷酸奥司他韦干糖浆 · No verified English nameCYHS2101839 Yunnan Xian Shi Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2021/10/12New drug · Class 1 NH600001乳状注射液 · No verified English nameCXHL2101555 Jiangsu En Hua Pharma Co., Ltd. romanized
2021/10/12New drug · Class 1 PBSS1113肠溶片 · No verified English nameCXHL2101554 Hangzhou Pu Ji Yuan Cheng Biopharmaceuticals Technology Co., Ltd. romanized
2021/10/12New drug · Class 1 PBSS1113肠溶片 · No verified English nameCXHL2101553 Hangzhou Pu Ji Yuan Cheng Biopharmaceuticals Technology Co., Ltd. romanized
2021/10/12New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2101552 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/10/12New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2101551 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/10/12New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2101550 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2021/10/12New drug · Class 1 THDBH130片 · No verified English nameCXHL2101549 Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized
2021/10/12New drug · Class 1 THDBH130片 · No verified English nameCXHL2101548 Nanjing Ming De Xin Yao Research and Development Co., Ltd. romanized
2021/10/12New drug · Class 2.3 缩宫素甲麦注射液 · No verified English nameCXHL2101547 Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized; Nanjing Ji Qun Pharmaceuticals Technology Co., Ltd. romanized
2021/10/12New drug · Class 2.3 缩宫素甲麦注射液 · No verified English nameCXHL2101546 Yuan Da Sheng Ming Ke Xue (Wuhan) Co., Ltd. romanized; Nanjing Ji Qun Pharmaceuticals Technology Co., Ltd. romanized
2021/10/12New drug · Class 2.2 非洛地平控释片 · No verified English nameCXHL2101545 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2021/10/11Generic · Class 3 Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2101830 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2021/10/11Generic · Class 3 Ornidazole InjectionCYHS2101828 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/10/11Generic · Class 3 Ornidazole InjectionCYHS2101827 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2021/10/11Generic · Class 3 Lidocaine CataplasmsCYHS2101824 Hainan Hui Yuan Tang Pharma Co., Ltd. romanized
2021/10/11New drug · Class 1 QLF31911注射液 · No verified English nameCXSL2101354 Qilu Pharmaceutical Co., Ltd.
2021/10/11New drug · Class 1 人源TH-SC01细胞注射液 · No verified English nameCXSL2101353 Jiangsu Tuo Hong Kang Heng Pharmaceuticals Co., Ltd. romanized
2021/10/11New drug · Class 1 ZX-101A胶囊 · No verified English nameCXHL2101543 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2021/10/11New drug · Class 1 ZX-101A胶囊 · No verified English nameCXHL2101542 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2021/10/11New drug · Class 1 ZX-101A胶囊 · No verified English nameCXHL2101541 Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized
2021/10/11New drug · Class 1 AN4005片 · No verified English nameCXHL2101540 Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized
2021/10/11New drug · Class 1 AN4005片 · No verified English nameCXHL2101539 Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized
2021/10/11New drug · Class 2.2 复方对乙酰氨基酚缓释片 · No verified English nameCXHL2101530 Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized
2021/10/09Import · Class 1 Troriluzole 胶囊 · No verified English nameJXHL2101196 Bioshin Limited; BioShin (Shanghai) Co. Ltd.
2021/10/09Import · Class 1 Troriluzole 胶囊 · No verified English nameJXHL2101195 Bioshin Limited; BioShin (Shanghai) Co. Ltd.
2021/10/09Import · Class 1 注射用 WCK5222 · No verified English nameJXHL2101191 Wockhardt Bio AG; Labcorp Pharmaceutical Research and Development (Beijing) Co. Ltd.

13 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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