YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 375 drug applications between 18 August 2023 and 24 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 63 drug names.

2023/08/18 – 2023/08/24

Period
2023/08/18 to 2023/08/24, 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
375
Drugs with new generic filings (by drug name, de-duplicated)
63
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

375filings, 85 of them generic

By application type

Application typeFilings
Supplement198
Generic85
New drug44
Import27
Unspecified11
Import re-registration10

By drug type

Drug typeFilings
Chemical drug254
TCM71
Therapeutic biologic40
Biologic6
Prophylactic biologic4

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

63 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Gadoteridol Injection413
2Potassium Chloride Injection3310
3Iopromide Injection3227
4Rivaroxaban Tablets313
5Tadalafil Tablets2223
6Famotidine Injection228
7Lornoxicam for Injection222
8Bortezomib For Injection221
9Labetalol Hydrochloride Injection224
10复方奥美拉唑干混悬剂 · No verified English name210

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

215 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized33320
2Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized11110
3Janssen Research & Development LLC730
4Changsha Ai Bei Gao Pharma Co., Ltd. romanized660
5Hainan Si Da Pharmaceutical Co., Ltd. romanized620
6GE Healthcare AS610
7Myokardia Inc.510
8Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized421
9Hainan Brilliant Pharmaceutical Co., Ltd.420
10Eli Lilly and Company410

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

113 this week

AcceptedDrugApplicants
2023/08/24Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2302257 Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2023/08/24Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2302256 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/08/24New drug · Class 3.3 注射用重组人促卵泡激素 · No verified English nameCXSS2300070 Beijing SL Pharmaceutical Co., Ltd.
2023/08/24New drug · Class 2.2 痘苗病毒致炎兔皮提取物注射液 · No verified English nameCXSL2300570 Wei Shi Pharma (Ru Gao) Co., Ltd. romanized
2023/08/24New drug · Class 2.2 泽贝妥单抗注射液 · No verified English nameCXSL2300569 Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2023/08/24New drug · Class 2.2 泽贝妥单抗注射液 · No verified English nameCXSL2300568 Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2023/08/24New drug · Class 1 GKL-006注射液 · No verified English nameCXSL2300567 Beijing Ji Yin Qi Ming Bio Technology Co., Ltd. romanized
2023/08/24New drug · Class 1 IBI356 · No verified English nameCXSL2300566 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/08/24New drug · Class 1 LM-101注射液 · No verified English nameCXSL2300564 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/08/24New drug · Class 2.4 注射用醋酸曲普瑞林微球 · No verified English nameCXHS2300072 Li Zhu Pharmaceuticals Group Co., Ltd. romanized; Shanghai Li Zhu Pharmaceutical Co., Ltd. romanized
2023/08/24New drug · Class 1 SHR0302片 · No verified English nameCXHS2300071 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/08/24New drug · Class 1 ACE-86225106片 · No verified English nameCXHL2300908 You Ling Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/08/24New drug · Class 1 ACE-86225106片 · No verified English nameCXHL2300907 You Ling Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/08/23Import · Class 1 JNJ-77242113-AAC片 · No verified English nameJXHL2300196 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/08/23Generic · Class 3 Famotidine InjectionCYHS2302251 Chengdu Mi Zi Biopharmaceuticals Technology Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2023/08/23Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2302250 Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/08/23Generic · Class 3 Sodium Bicarbonate InjectionCYHS2302249 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2023/08/23Generic · Class 3 Nicorandil for InjectionCYHS2302248 Chongqing Lai Mei Pharma Co., Ltd. romanized
2023/08/23Generic · Class 3 Nicorandil for InjectionCYHS2302247 Chongqing Lai Mei Pharma Co., Ltd. romanized
2023/08/23Generic · Class 3 Atenolol TabletsCYHS2302246 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2023/08/23Generic · Class 3 Atenolol TabletsCYHS2302245 Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized
2023/08/23Generic · Class 3 Magnesium Sulfate InjectionCYHS2302240 Fujian Tian Quan Pharma Co., Ltd. romanized
2023/08/23Generic · Class 3 Magnesium Sulfate InjectionCYHS2302238 Fujian Tian Quan Pharma Co., Ltd. romanized
2023/08/23Generic · Class 3 Scopolamine Butylbromide InjectionCYHS2302236 Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/08/23Generic · Class 3 Potassium Chloride InjectionCYHS2302235 Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/08/23Generic · Class 3 维A酸外用乳 · No verified English nameCYHL2300105 Chongqing Huapont Pharmaceutical Co., Ltd.
2023/08/23New drug · Class 1 依若奇单抗注射液 · No verified English nameCXSS2300069 Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized; Kang Rong Dong Fang (Guangdong) Pharmaceuticals Co., Ltd. romanized
2023/08/23New drug · Class 3.4 注射用替奈普酶 · No verified English nameCXSS2300068 Shi Mao Tian Jie Pharmaceutical (Jiangsu) Co., Ltd. romanized
2023/08/23New drug · Class 1 SYS6011 · No verified English nameCXSL2300563 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2023/08/23New drug · Class 1 NCR300注射液 · No verified English nameCXSL2300562 Anhui Zhong Sheng Su Yuan Bio Technology Co., Ltd. romanized

83 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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