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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 241 drug applications between 23 November 2021 and 29 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 38, covering 27 drug names.

2021/11/23 – 2021/11/29

Period
2021/11/23 to 2021/11/29, 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
241
Drugs with new generic filings (by drug name, de-duplicated)
27
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

241filings, 38 of them generic

By application type

Application typeFilings
Supplement125
Generic38
New drug35
Import28
Unspecified12
Import re-registration3

By drug type

Drug typeFilings
Chemical drug167
Therapeutic biologic38
TCM31
Prophylactic biologic3
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

27 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Temozolomide Capsules310
2Dexmedetomidine Hydrochloride Injection311
3Rivaroxaban Tablets223
4Moxifloxacin Hydrochloride Eye Drops224
5Tadalafil Tablets2123
6Obeticholic Acid Tablets210
7Fluorouracil Injection216
8Dexmedetomidine Hydrochloride Injection210
9Esomeprazole Magnesium for Delayed-release Oral Suspension214
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

130 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Wuhan Ai Min Pharmaceutical Co., Ltd. romanized18160
2Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized10100
3Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized740
4Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized540
5Sichuan Guo Rui Pharma Co., Ltd. romanized525
6F. Hoffmann-La Roche Ltd430
7ViiV Healthcare BV430
8Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized434
9AstraZeneca AB420
10Pfizer Europe MA EEIG410

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

70 this week

AcceptedDrugApplicants
2021/11/29Import · Class 1 BAY 2586116鼻喷雾剂 · No verified English nameJXHL2101259 Bayer AG; Bayer Healthcare Company Ltd.
2021/11/29Import · Class 1 BAY 2586116鼻喷雾剂 · No verified English nameJXHL2101258 Bayer AG; Bayer Healthcare Company Ltd.
2021/11/29Import · Class 1 BAY 2586116鼻喷雾剂 · No verified English nameJXHL2101257 Bayer AG; Bayer Healthcare Company Ltd.
2021/11/29Generic · Class 3 Procaterol Hydrochloride Solution for InhalationCYHS2102099 Nanjing Hua Gai Pharmaceutical Co., Ltd. romanized
2021/11/29Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2102095 Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized; Yang Zi Jiang Pharma Group Jiangsu Zi Long Pharma Co., Ltd. romanized
2021/11/29Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2102094 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2021/11/29Generic · Class 3 Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2102093 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2021/11/29New drug · Class 3.2 注射用重组人甲状旁腺素(1-84) · No verified English nameCXSL2101455 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized
2021/11/29New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101454 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2021/11/29New drug · Class 1 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2101453 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2021/11/29New drug · Class 1 CAB-ROR2-ADC注射剂 · No verified English nameCXSL2101439 Kai Bo Si (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2021/11/29New drug · Class 1 HSK31858片 · No verified English nameCXHL2101696 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2021/11/29New drug · Class 1 HSK31858片 · No verified English nameCXHL2101695 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2021/11/29New drug · Class 1 JMKX000189注射液 · No verified English nameCXHL2101694 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2021/11/29New drug · Class 1 注射用PMS-001 · No verified English nameCXHL2101693 Qingdao Pu Mei Sheng Pharmaceuticals Technology Co., Ltd. romanized
2021/11/29New drug · Class 1 TLL-018片 · No verified English nameCXHL2101692 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2021/11/29New drug · Class 1 BGT-002片 · No verified English nameCXHL2101691 Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized
2021/11/29New drug · Class 1 BGT-002片 · No verified English nameCXHL2101690 Bo Ji Yuan (Shanghai) Biopharmaceuticals Co., Ltd. romanized
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

40 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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