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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 210 drug applications between 29 July 2021 and 4 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 31, covering 24 drug names.

2021/07/29 – 2021/08/04

Period
2021/07/29 to 2021/08/04, 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
210
Drugs with new generic filings (by drug name, de-duplicated)
24
Accepted this week, now under review
1

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

210filings, 31 of them generic

By application type

Application typeFilings
Supplement97
New drug50
Generic31
Import16
Unspecified9
Import re-registration7

By drug type

Drug typeFilings
Chemical drug144
Therapeutic biologic33
TCM31
In vitro diagnostic reagent1
Prophylactic 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

24 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Carbamazepine Extended-release Tablets310
2Alanyl Glutamine Injection214
3Carbazochrome Sodium Sulfonate Injection211
4Caspofungin Acetate for Injection218
5Trimetazidine Dihydrochloride Tablets210
6Oseltamivir Phosphate Capsules2139
7Ezetimibe Tablets114
8Lidocaine and Prilocaine Cream1124
9Bromhexine Hydrochloride Solution For Inhalation111
10富马酸替诺福韦二吡呋酯颗粒 · No verified English name110

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

126 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanxi Fu Ren Heng Feng Pharma Co., Ltd. romanized11110
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized940
3Shaanxi An Yuan Tang Pharma Co., Ltd. romanized660
4San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized630
5Eli Lilly and Company610
6CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD520
7Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized320
8Jiangsu Hao Sen Pharma Group Co., Ltd. romanized320
9Bristol-Myers Squibb Pharma EEIG310
10Chengdu Kang Hong Pharma Group Co., Ltd. romanized310

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

72 this week

AcceptedDrugApplicants
2021/08/03Import · Class 2.2 DS-8201a · No verified English nameJXSL2101086 Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited
2021/08/03Import · Class 1 BI 905711输注用粉末 · No verified English nameJXSL2101085 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2021/08/03Import · Class 1 NIS793 · No verified English nameJXSL2101079 Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd
2021/08/03Import · Class 1 AR882胶囊 · No verified English nameJXHL2101149 Arthrosi Therapeutics INC; Hangzhou Tigermed Consulting Co. Ltd.
2021/08/03Import · Class 1 Elinzanetant 软胶囊 · No verified English nameJXHL2101148 Bayer AG; Bayer Healthcare Company Ltd.
2021/08/03Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHS2101521 Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2021/08/03Generic · Class 3 Carbamazepine Extended-release TabletsCYHS2101519 Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2021/08/03Generic · Class 3 Carbamazepine Extended-release TabletsCYHS2101518 Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2021/08/03Generic · Class 3 Carbamazepine Extended-release TabletsCYHS2101517 Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2021/08/03Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2101510 Kang Pu Pharma Co., Ltd. romanized
2021/08/03Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2101509 Kang Pu Pharma Co., Ltd. romanized
2021/08/03Generic · Class 3 Calcitriol Oral SolutionCYHS2101503 Xinjiang Te Feng Pharma Co., Ltd. romanized
2021/08/03Generic · Class 3 Famciclovir TabletsCYHS2101501 Di Sha Pharma Group Co., Ltd. romanized
2021/08/03Generic · Class 3 富马酸替诺福韦二吡呋酯颗粒 · No verified English nameCYHS2101480 Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2021/08/03New drug · Class 3.4 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液 · No verified English nameCXSS2101018 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/08/03New drug · Class 3.4 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液 · No verified English nameCXSS2101017 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/08/03New drug · Class 3.3 贝伐珠单抗注射液 · No verified English nameCXSS2101016 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2021/08/03New drug · Class 3.4 重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液 · No verified English nameCXSS2101013 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/08/03New drug · Class 1 AK117注射液 · No verified English nameCXSL2101236 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/08/03New drug · Class 1 AK112注射液 · No verified English nameCXSL2101235 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized
2021/08/03New drug · Class 1 注射用金纳单抗 · No verified English nameCXSL2101234 Changchun Jin Sai Pharma Co., Ltd. romanized
2021/08/03New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2101233 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/08/03New drug · Class 1 SI-B001双特异性抗体注射液 · No verified English nameCXSL2101232 Sichuan Bai Li Pharma Co., Ltd. romanized
2021/08/03New drug · Class 1 注射用CAN103 · No verified English nameCXSL2101231 Bei Hai Kang Cheng (Suzhou) Biopharmaceutical Co., Ltd. romanized
2021/08/03New drug · Class 1 SHR-1701注射液 · No verified English nameCXSL2101230 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/08/03New drug · Class 3.3 冻干b型流感嗜血杆菌结合疫苗 · No verified English nameCXSL2101229 Beijing Ke Xing Zhong Wei Bio Technology Co., Ltd. romanized
2021/08/03New drug · Class 1 重组人源化抗PCSK9单克隆抗体注射液 · No verified English nameCXSL2101227 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/08/03New drug · Class 1 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101225 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2021/08/03New drug · Class 1 注射用SHR-A2009 · No verified English nameCXSL2101222 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2021/08/03New drug · Class 2.2 他达拉非口溶膜 · No verified English nameCXHS2101034 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Hao Sen Pharma Group Co., Ltd. romanized

42 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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