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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 309 drug applications between 21 September 2022 and 27 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 52, covering 46 drug names.

2022/09/21 – 2022/09/27

Period
2022/09/21 to 2022/09/27, 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
309
Drugs with new generic filings (by drug name, de-duplicated)
46
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

309filings, 52 of them generic

By application type

Application typeFilings
Supplement154
New drug57
Generic52
Unspecified19
Import19
Import re-registration8

By drug type

Drug typeFilings
Chemical drug217
Therapeutic biologic49
TCM28
Biologic14
In vitro diagnostic reagent1

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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Oseltamivir Phosphate Capsules3139
2Allopurinol Tablets214
3Dopamine Hydrochloride Injection213
4Calcium Gluconate in Sodium Chloride Injection215
5Choline Fenofibrate Sustained-release Capsules211
6Acetylcysteine Granules114
7Tacrolimus Sustained-release Capsules116
8Tafluprost Eye Drops113
9Lidocaine Cataplasms117
10Indobufen Tablets116

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

176 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Mei Lin Pharma Co., Ltd. romanized22160
2Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized22160
3Shanghai Yan An Pharma Co., Ltd. romanized880
4Vetter Pharma-Fertigung GmbH & Co. KG820
5Da Lian Tian Shan Pharma Co., Ltd. romanized660
6NAPP PHARMACEUTICALS LIMITED610
7Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized550
8Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized440
9Takeda Development Center Americas Inc.420
10Changchun Jin Sai Pharma Co., Ltd. romanized420

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

86 this week

AcceptedDrugApplicants
2022/09/27Generic · Class 3 Pentoxifylline InjectionCYHS2201620 Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
2022/09/27Generic · Class 3 Potassium Aspartate InjectionCYHS2201618 Yang Pu Jing Tai Pharma Co., Ltd. romanized; Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized
2022/09/27New drug · Class 1.1 傣肾宁颗粒 · No verified English nameCXZL2200044 Xi Shuang Ban Na Dai Zu Zi Zhi Zhou Dai Yi Hospital romanized
2022/09/27New drug · Class 3.4 重组人促卵泡激素注射液 · No verified English nameCXSS2200082 Changchun Jin Sai Pharma Co., Ltd. romanized
2022/09/27New drug · Class 3.4 重组人促卵泡激素注射液 · No verified English nameCXSS2200081 Changchun Jin Sai Pharma Co., Ltd. romanized
2022/09/27New drug · Class 3.4 重组人促卵泡激素注射液 · No verified English nameCXSS2200080 Changchun Jin Sai Pharma Co., Ltd. romanized
2022/09/27New drug · Class 1 PM1103注射液 · No verified English nameCXSL2200490 Pu Mi Si Biopharmaceutical (Nan Tong) Co., Ltd. romanized
2022/09/27New drug · Class 1 注射用AP026 · No verified English nameCXSL2200489 An Yuan Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/09/27New drug · Class 1 JY47注射液 · No verified English nameCXSL2200488 Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized
2022/09/27New drug · Class 1 BRG01注射液 · No verified English nameCXSL2200487 Guangzhou Bai Ji Biopharmaceutical Co., Ltd. romanized
2022/09/27New drug · Class 1 GR2001注射液 · No verified English nameCXSL2200485 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized; Zhi Xiang (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized
2022/09/27New drug · Class 1 注射用LH021 · No verified English nameCXHL2200736 Guangzhou Ling Cheng Medical Technology Co., Ltd. romanized
2022/09/27New drug · Class 1 XNW7201片 · No verified English nameCXHL2200735 Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2022/09/26Generic · Class 3 Allopurinol TabletsCYHS2201610 Chengdu Brilliant Pharmaceutical Co., Ltd.
2022/09/26Generic · Class 3 Allopurinol TabletsCYHS2201609 Chengdu Brilliant Pharmaceutical Co., Ltd.
2022/09/26New drug · Class 1 重组人源化单克隆抗体MIL93注射液 · No verified English nameCXSL2200483 Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized
2022/09/26New drug · Class 1 重组人IL12/15-PDL1B单纯疱疹Ⅰ型溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2200482 Zhong Sheng Fu Nuo Jian Bio Technology (Shanghai) Co., Ltd. romanized
2022/09/25Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2201608 Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2022/09/25Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2201607 Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2022/09/24Import · Class 1 ALXN1720注射液 · No verified English nameJXSL2200172 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2022/09/24Import · Class 1 Futuximab/Modotuximab 注射液 (S95026) · No verified English nameJXSL2200171 Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development CO. LTD
2022/09/24Import · Class 1 Nemtabrutinib片 · No verified English nameJXHL2200294 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2022/09/24Import · Class 1 Nemtabrutinib片 · No verified English nameJXHL2200293 Merck Sharp & Dohme LLC a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd.
2022/09/24Generic · Class 3 Rivastigmine Hydrogen Tartrate Oral SolutionCYHS2201604 Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Kai Run Pharma Co., Ltd. romanized
2022/09/24New drug · Class 2.3 养正消积胶囊 · No verified English nameCXZL2200043 Shijiazhuang Yi Ling Pharma Co., Ltd. romanized
2022/09/24New drug · Class 1 靶向HLA-A*02:01/NY-ESO-1的TCR-T细胞注射液 · No verified English nameCXSL2200481 Shenzhen Pu Rui Jin Bio Pharma Co., Ltd. romanized
2022/09/24New drug · Class 1 GC301腺相关病毒注射液 · No verified English nameCXSL2200480 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2022/09/24New drug · Class 1 注射用QLS31903 · No verified English nameCXSL2200479 Qilu Pharmaceutical Co., Ltd.
2022/09/24New drug · Class 1 伯瑞替尼肠溶胶囊 · No verified English nameCXHS2200048 Beijing Pu Run Ao Bio Technology Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2022/09/24New drug · Class 1 伯瑞替尼肠溶胶囊 · No verified English nameCXHS2200047 Beijing Pu Run Ao Bio Technology Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized

56 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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