YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 204 drug applications between 22 July 2021 and 28 July 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 25, covering 18 drug names.

2021/07/22 – 2021/07/28

Period
2021/07/22 to 2021/07/28, 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
204
Drugs with new generic filings (by drug name, de-duplicated)
18
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

204filings, 25 of them generic

By application type

Application typeFilings
Supplement108
New drug41
Generic25
Import20
Unspecified7
Import re-registration3

By drug type

Drug typeFilings
Chemical drug130
Therapeutic biologic41
TCM23
Prophylactic biologic8
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

18 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Neostigmine Methylsulfate Injection314
2Carbetocin Injection226
3Empagliflozin Tablets2118
4Pregabalin Capsules2112
5Micafungin Sodium for Injection210
6Dapagliflozin Tablets2184
7Enoxaparin Sodium Injection1116
8Limaprost Alfadex Tablets110
9Doxofylline Injection115
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

124 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Lin Hai Xue Yuan Pharma Co., Ltd. romanized880
2Jiangsu Hao Sen Pharma Group Co., Ltd. romanized732
3Janssen-Cilag International NV540
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
7Merck Sharp & Dohme Corp.320
8SANOFI PASTEUR320
9Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized320
10Qilu Pharmaceutical Co., Ltd.320

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

64 this week

AcceptedDrugApplicants
2021/07/28Import · Class 1 MK-4280A注射液 · No verified English nameJXSL2101080 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2021/07/28Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHL2101144 Eisai Europe Ltd.
2021/07/28Import · Class 2.4 Lenvatinib Mesilate CapsulesJXHL2101143 Eisai Europe Ltd.
2021/07/28Generic · Class 3 Citicoline Sodium InjectionCYHS2101492 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/07/28New drug · Class 1 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101221 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/07/28New drug · Class 1 注射用QLF32004 · No verified English nameCXSL2101220 Qilu Pharmaceutical Co., Ltd.
2021/07/28New drug · Class 1 HS-10375片 · No verified English nameCXHL2101340 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/07/28New drug · Class 1 HS-10375片 · No verified English nameCXHL2101339 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/07/28New drug · Class 1 ICP-189片 · No verified English nameCXHL2101338 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2021/07/28New drug · Class 1 HS-10381胶囊 · No verified English nameCXHL2101336 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/07/28New drug · Class 1 HS-10381胶囊 · No verified English nameCXHL2101335 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2021/07/28New drug · Class 1 HS-10381胶囊 · No verified English nameCXHL2101334 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
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

34 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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