YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 205 drug applications between 21 July 2021 and 27 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 24 drug names.

2021/07/21 – 2021/07/27

Period
2021/07/21 to 2021/07/27, 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
205
Drugs with new generic filings (by drug name, de-duplicated)
24
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

205filings, 32 of them generic

By application type

Application typeFilings
Supplement113
New drug35
Generic32
Import17
Unspecified5
Import re-registration3

By drug type

Drug typeFilings
Chemical drug131
Therapeutic biologic42
TCM21
Prophylactic biologic9
Biologic2

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

24 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Neostigmine Methylsulfate Injection314
2Carbetocin Injection226
3Pregabalin Capsules2112
4Micafungin Sodium for Injection210
5Iodixanol Injection210
6Eldecalcitol Soft Capsules218
7Dapagliflozin Tablets2184
8Enoxaparin Sodium Injection1116
9Limaprost Alfadex Tablets110
10Tenofovir alafenamide Fumarate Tablets110

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

132 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized880
2Janssen-Cilag International NV540
3SANOFI PASTEUR420
4Guangzhou Bai Te Medical Yong Pin Co., Ltd. romanized420
5Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized410
6Hefei Li Fang Pharmaceutical Co., Ltd. romanized330
7Xian Tang Chen Pharmaceutical Co., Ltd. romanized330
8Novo Nordisk A/S320
9Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized320
10Pfizer Europe MA EEIG310

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

56 this week

AcceptedDrugApplicants
2021/07/27Import · Class 3.1 耐多种抗生素克劳氏芽孢杆菌芽孢口服混悬剂 · No verified English nameJXSL2101078 Sanofi S.r.l.; Sanofi (China) Investment Co. Ltd.
2021/07/27Import · Class 1 Epcoritamab注射用浓溶液 · No verified English nameJXSL2101077 Genmab US Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2021/07/27Import · Class 1 Epcoritamab注射液 · No verified English nameJXSL2101076 Genmab US Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2021/07/27Import · Class 1 Epcoritamab注射用浓溶液 · No verified English nameJXSL2101075 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2021/07/27Import · Class 1 Epcoritamab注射液 · No verified English nameJXSL2101074 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2021/07/27Import · Class 1 ABL001片 · No verified English nameJXHL2101141 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2021/07/27New drug · Class 1.1 艾拉片 · No verified English nameCXZL2101020 Zhongguo Ke College Xinjiang Li Hua Technology Research Institute romanized
2021/07/27New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2101219 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/07/27New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101218 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/07/27New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2101217 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2021/07/27New drug · Class 1 SHR0302片 · No verified English nameCXHL2101331 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2021/07/27New drug · Class 1 SHR0302片 · No verified English nameCXHL2101330 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2021/07/27New drug · Class 1 OT202滴眼液 · No verified English nameCXHL2101326 Ou Kang Wei Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2021/07/27New drug · Class 1 OT202滴眼液 · No verified English nameCXHL2101325 Ou Kang Wei Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2021/07/27New drug · Class 1 OT202滴眼液 · No verified English nameCXHL2101324 Ou Kang Wei Shi Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2021/07/27New drug · Class 1 HMPL-760胶囊 · No verified English nameCXHL2101320 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/07/27New drug · Class 1 HMPL-760胶囊 · No verified English nameCXHL2101319 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/07/27New drug · Class 1 HMPL-760胶囊 · No verified English nameCXHL2101318 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized
2021/07/27New drug · Class 1 ACT001胶囊 · No verified English nameCXHL2101311 Xin Yi Shang De Yao Yuan Pharma Co., Ltd. romanized
2021/07/26Import · Class 1 RO7030816 · No verified English nameJXSL2101073 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/07/26Import · Class 1 RO7030816 · No verified English nameJXSL2101072 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2021/07/26Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101071 Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd.
2021/07/26Import · Class 1 PF-06823859注射液 · No verified English nameJXSL2101070 Pfizer Inc.; Pfizer Investment Co. Ltd.
2021/07/26Import · Class 2.4 Lazertinib片 · No verified English nameJXHL2101140 Janssen-Cilag International NV; Johnson & Johnson (China) Investment Ltd.
2021/07/26Generic · Class 3 Limaprost Alfadex TabletsCYHS2101475 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2021/07/26New drug · Class 1 QX006N注射液 · No verified English nameCXSL2101214 Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized
2021/07/26New drug · Class 1 注射用BC3448 · No verified English nameCXSL2101213 Wuxi Zhi Kang Hong Yi Bio Technology Co., Ltd. romanized
2021/07/26New drug · Class 2.4 硝羟喹啉片 · No verified English nameCXHL2101329 Jiangsu Ya Hong Pharmaceuticals Technology Co., Ltd. romanized
2021/07/26New drug · Class 1 注射用TB001 · No verified English nameCXHL2101328 Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized
2021/07/26New drug · Class 1 注射用TB001 · No verified English nameCXHL2101327 Shenzhen Shi Tu Wei An Chuang Technology Kai Fa Co., Ltd. romanized

26 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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