YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 250 drug applications between 24 November 2021 and 30 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 37, covering 27 drug names.

2021/11/24 – 2021/11/30

Period
2021/11/24 to 2021/11/30, 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
250
Drugs with new generic filings (by drug name, de-duplicated)
27
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

250filings, 37 of them generic

By application type

Application typeFilings
Supplement136
New drug38
Generic37
Import25
Unspecified11
Import re-registration3

By drug type

Drug typeFilings
Chemical drug160
TCM46
Therapeutic biologic39
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
2Citicoline Sodium Injection313
3Rivaroxaban Tablets223
4Tadalafil Tablets2123
5Perindopril tert-Butylamine Tablets215
6Fluorouracil Injection216
7Parecoxib Sodium for Injection212
8Esomeprazole Magnesium for Delayed-release Oral Suspension214
9厄贝沙坦氢氯噻嗪片 · No verified English name115
10Procaterol Hydrochloride Solution for Inhalation112

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

134 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Wuhan Ai Min Pharmaceutical Co., Ltd. romanized24190
2Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized990
3Shijiazhuang Yu He Tang Pharma Co., Ltd. romanized880
4Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized740
5Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized540
6ViiV Healthcare BV430
7Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized434
8AstraZeneca AB420
9Pfizer Europe MA EEIG410
10Roche Pharma (Schweiz) AG410

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

65 this week

AcceptedDrugApplicants
2021/11/30Import · Class 2.2 度普利尤单抗注射液 · No verified English nameJXSL2101140 Sanofi-aventis recherche & développement; Sanofi(China) Investment Co. LTD
2021/11/30Generic · Class 3 Citicoline Sodium InjectionCYHS2102110 Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2021/11/30Generic · Class 3 Citicoline Sodium InjectionCYHS2102109 Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2021/11/30Generic · Class 3 Citicoline Sodium InjectionCYHS2102108 Beijing Jin Cheng Tai Er Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2021/11/30Generic · Class 3 Furosemide InjectionCYHS2102082 Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized
2021/11/30New drug · Class 1.2 补骨脂总苷胶囊 · No verified English nameCXZL2101037 Jiangsu Sheng Zhong Pharmaceuticals Research Institute romanized
2021/11/30New drug · Class 1.2 补骨脂总苷提取物 · No verified English nameCXZL2101036 Jiangsu Sheng Zhong Pharmaceuticals Research Institute romanized
2021/11/30New drug · Class 1 人羊膜上皮干细胞注射液 · No verified English nameCXSL2101456 Shanghai Sai Ao Bio Technology Co., Ltd. romanized
2021/11/30New drug · Class 1 JAB-6343胶囊 · No verified English nameCXHL2101698 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/11/30New drug · Class 1 JAB-6343胶囊 · No verified English nameCXHL2101697 Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized
2021/11/30New drug · Class 2.2 注射用前列地尔脂质体 · No verified English nameCXHL2101689 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
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

35 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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