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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 245 drug applications between 8 September 2021 and 14 September 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 23 drug names.

2021/09/08 – 2021/09/14

Period
2021/09/08 to 2021/09/14, 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
245
Drugs with new generic filings (by drug name, de-duplicated)
23
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

245filings, 32 of them generic

By application type

Application typeFilings
Supplement146
New drug42
Generic32
Import13
Unspecified10
Import re-registration2

By drug type

Drug typeFilings
Chemical drug171
Therapeutic biologic39
TCM28
Prophylactic biologic4
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

23 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Milrinone Injection320
2阿普米司特片 · No verified English name313
3Olmesartan Medoxomil and Hydrochlorothiazide Tablets223
4Pitavastatin Calcium Tablets210
5Ambroxol Hydrochloride Solution For Inhalation2110
6Amisulpride Tablets210
7Levocetirizine dihydrochloride Oral Solution215
8二氟泼尼酯滴眼液 · No verified English name110
9Clotrimazole Vaginal Tablets113
10Rivaroxaban Tablets113

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
1Ping Guang Pharmaceutical Co., Ltd. romanized22210
2Guizhou Miao Ren Tang Biopharmaceuticals Technology Co., Ltd. romanized770
3Eli Lilly Nederland B.V.630
4Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized610
5Bristol-Myers Squibb Pharma EEIG510
6Shijiazhuang No.4 Pharmaceutical Co., Ltd.422
7CSPC OUYI PHARMACEUTICAL CO., LTD.423
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized410
9Novo Nordisk A/S330
10Ji Chuan Pharma Group Co., Ltd. romanized330

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

60 this week

AcceptedDrugApplicants
2021/09/14Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSL2101109 Merck Sharp & Dohme Corp.; MSD R&D (China) Co. Ltd.
2021/09/14Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2101177 Seagen Inc.; MSD R&D (China) Co. Ltd.
2021/09/14Import · Class 2.4 Tucatinib片 · No verified English nameJXHL2101176 Seagen Inc.; MSD R&D (China) Co. Ltd.
2021/09/14Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2101730 Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2021/09/14Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2101729 Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2021/09/14Generic · Class 3 Milrinone InjectionCYHS2101728 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2021/09/14Generic · Class 3 二氟泼尼酯滴眼液 · No verified English nameCYHS2101727 Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized
2021/09/14Generic · Class 3 Omeprazole and Sodium Bicarbonate CapsulesCYHS2101719 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.
2021/09/14New drug · Class 3.4 人凝血因子Ⅷ · No verified English nameCXSS2101029 Hua Lan Bio Gong Cheng Chongqing Co., Ltd. romanized
2021/09/14New drug · Class 3.4 人凝血因子Ⅷ · No verified English nameCXSS2101028 Hua Lan Bio Gong Cheng Chongqing Co., Ltd. romanized
2021/09/14New drug · Class 1 TQB2868注射液 · No verified English nameCXSL2101325 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2021/09/14New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2101479 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2021/09/14New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2101478 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2021/09/14New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2101477 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2021/09/14New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2101476 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2021/09/14New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2101475 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2021/09/14New drug · Class 1 TY-302胶囊 · No verified English nameCXHL2101474 Zhejiang Tong Yuan Kang Pharmaceuticals Co., Ltd. romanized
2021/09/13Import · Class 1 IcoSema 注射液 · No verified English nameJXSL2101108 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2021/09/13Import · Class 1 TPX-0022胶囊 · No verified English nameJXHL2101174 Turning Point Therapeutics Inc.; Zai Lab (Shanghai) Co. Ltd.
2021/09/13Import · Class 2.4 ATG-010片 · No verified English nameJXHL2101172 Karyopharm Therapeutics Inc.; Antengene Corporation Co. Ltd.
2021/09/13Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2101715 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2021/09/13Generic · Class 3 Ambroxol Hydrochloride Solution For InhalationCYHS2101714 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2021/09/13Generic · Class 3 阿奇霉素颗粒(Ⅱ) · No verified English nameCYHS2101710 Jiangxi Yi You Pharma Co., Ltd. romanized
2021/09/13Generic · Class 3 Milrinone InjectionCYHS2101702 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/09/13Generic · Class 3 Milrinone InjectionCYHS2101701 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2021/09/13Generic · Class 3 Citicoline Sodium InjectionCYHS2101682 Shandong Yu Man Kun Bio Technology Co., Ltd. romanized; Rui Yang Pharmaceutical Co., Ltd. romanized
2021/09/13New drug · Class 1 JS012注射液 · No verified English nameCXSL2101324 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2021/09/13New drug · Class 3.2 ACYW135群脑膜炎球菌多糖结合疫苗 · No verified English nameCXSL2101323 Ai Mei Wei Xin Bio Pharma (Zhejiang) Co., Ltd. romanized
2021/09/13New drug · Class 1 BGB-A445注射液 · No verified English nameCXSL2101322 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2021/09/13New drug · Class 2.2 注射用卡瑞利珠单抗 · No verified English nameCXSL2101321 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized

30 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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