YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 246 drug applications between 20 November 2021 and 26 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 25 drug names.

2021/11/20 – 2021/11/26

Period
2021/11/20 to 2021/11/26, 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
246
Drugs with new generic filings (by drug name, de-duplicated)
25
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

246filings, 35 of them generic

By application type

Application typeFilings
Supplement130
Generic35
New drug35
Import29
Unspecified14
Import re-registration3

By drug type

Drug typeFilings
Chemical drug176
Therapeutic biologic38
TCM24
Prophylactic biologic5
Biologic3

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

25 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Temozolomide Capsules310
2Dexmedetomidine Hydrochloride Injection311
3Moxifloxacin Hydrochloride Eye Drops224
4Tadalafil Tablets2123
5Obeticholic Acid Tablets210
6Fluorouracil Injection216
7Dexmedetomidine Hydrochloride Injection210
8Aprepitant Capsules210
9Rivaroxaban Tablets113
10卡格列净二甲双胍缓释片 · No verified English name115

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

143 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized13130
2Wuhan Ai Min Pharmaceutical Co., Ltd. romanized990
3Actelion Pharmaceuticals Ltd810
4Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized740
5Pan Shi Ju Kang Pharma Co., Ltd. romanized540
6Sichuan Guo Rui Pharma Co., Ltd. romanized525
7F. Hoffmann-La Roche Ltd430
8ViiV Healthcare BV430
9Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized434
10AstraZeneca AB420

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

69 this week

AcceptedDrugApplicants
2021/11/26Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2101033 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2021/11/26Import · Class 1 HBM9161(HL161BKN)注射液 · No verified English nameJXSL2101139 Harbour BioMed Therapeutics Limited; He Bo Pharmaceuticals (Suzhou) Co., Ltd. romanized
2021/11/26Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2101261 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/11/26Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2101260 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2021/11/26New drug · Class 1.2 丹酚酸A · No verified English nameCXZL2101035 Jiangxi Qing Feng Pharma Co., Ltd. romanized
2021/11/26New drug · Class 1 SI-B003双特异性抗体注射液 · No verified English nameCXSL2101452 Sichuan Bai Li Pharma Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2021/11/26New drug · Class 1 SI-B003双特异性抗体注射液 · No verified English nameCXSL2101451 Sichuan Bai Li Pharma Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2021/11/26New drug · Class 1 KN052注射液 · No verified English nameCXSL2101450 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2021/11/26New drug · Class 1 PM1022 注射液 · No verified English nameCXSL2101447 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2021/11/26New drug · Class 1 重组抗IL-4Rα单域抗体雾化液(毕赤酵母) · No verified English nameCXSL2101446 Shanghai Luo Qi Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/26New drug · Class 1 ES002023注射液 · No verified English nameCXSL2101445 Ke Wang (Suzhou) Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/26New drug · Class 1 硝酮嗪肠溶片 · No verified English nameCXHL2101688 Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized
2021/11/26New drug · Class 1 硝酮嗪肠溶片 · No verified English nameCXHL2101687 Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized
2021/11/26New drug · Class 2.1 MBT-1608片 · No verified English nameCXHL2101683 Beijing SL Pharmaceutical Co., Ltd.
2021/11/25Generic · Class 3 Levofloxacin InjectionCYHS2102083 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2021/11/25Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2102064 Sichuan Guo Rui Pharma Co., Ltd. romanized
2021/11/25New drug · Class 1.2 注射用丹酚酸A · No verified English nameCXZL2101034 Jiangxi Qing Feng Pharma Co., Ltd. romanized
2021/11/25New drug · Class 1 WJ05129片 · No verified English nameCXHL2101686 Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/25New drug · Class 1 WJ05129片 · No verified English nameCXHL2101685 Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2021/11/24Import · Class 2.2 纳武利尤单抗注射液 · No verified English nameJXSL2101138 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/11/24Import · Class 1 NKTR-214 · No verified English nameJXSL2101137 Nektar Therapeutics; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/11/24Import · Class 1 NKTR-214 · No verified English nameJXSL2101136 Nektar Therapeutics; Bristol-Myers Squibb (China) Investment Co. Ltd
2021/11/24Import · Class 2.3; 2.4 CARDIX-101胶囊 · No verified English nameJXHL2101254 CARDIX THERAPEUTICS LLC; SHANGHAI GENOMICS INC
2021/11/24Import · Class 2.3; 2.4 CARDIX-101胶囊 · No verified English nameJXHL2101253 CARDIX THERAPEUTICS LLC; SHANGHAI GENOMICS INC
2021/11/24Import · Class 2.3 CARDIX-101胶囊 · No verified English nameJXHL2101252 CARDIX THERAPEUTICS LLC; SHANGHAI GENOMICS INC
2021/11/24Generic · Class 3 Sumatriptan and Naproxen Sodium TabletsCYHS2102076 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2021/11/24Generic · Class 3 Fluorouracil InjectionCYHS2102075 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/11/24Generic · Class 3 Fluorouracil InjectionCYHS2102074 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/11/24New drug · Class 1 自体自然杀伤细胞注射液 · No verified English nameCXSL2101444 Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized
2021/11/24New drug · Class 1 CAStem细胞注射液 · No verified English nameCXSL2101443 Beijing Ze Hui Chen Xing Bio Technology Co., Ltd. romanized

39 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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