YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 212 drug applications between 3 May 2024 and 9 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 46 drug names.

2024/05/03 – 2024/05/09

Period
2024/05/03 to 2024/05/09, 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
212
Drugs with new generic filings (by drug name, de-duplicated)
46
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

212filings, 60 of them generic

By application type

Application typeFilings
Supplement94
Generic60
New drug31
Import14
Import re-registration9
Unspecified4

By drug type

Drug typeFilings
Chemical drug137
Therapeutic biologic37
TCM36
Prophylactic 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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Telmisartan Tablets314
2Deutetrabenazine Tablets310
3Lactulose Oral Solution2134
4二甲硅油乳剂 · No verified English name2114
5Perampanel Tablets212
6Procaterol Hydrochloride Solution for Inhalation212
7头孢地尼干混悬剂 · No verified English name212
8Vonoprazan Fumarate Tablets2160
9Cytarabine for Injection212
10Calcium Gluconate in Sodium Chloride Injection215

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

140 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bai Ao Tai Biopharmaceutical Co., Ltd. romanized630
2Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.623
3Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized550
4Hubei Di Liu Pharmaceutical Co., Ltd. romanized530
5Chongqing Sai Wei Pharma Co., Ltd. romanized510
6AstraZeneca AB430
7Takeda Pharmaceuticals International AG Ireland Branch420
8Topfond Pharmaceutical Co., Ltd.424
9Ma Ying Long Pharma Group Co., Ltd. romanized330
10Qilu Pharmaceutical Co., Ltd.320

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
2024/05/09Import · Class 1 LOXO-435片 · No verified English nameJXHL2400104 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/09Import · Class 1 LOXO-435片 · No verified English nameJXHL2400103 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/09Import · Class 1 LOXO-435片 · No verified English nameJXHL2400102 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/05/09Import · Class 2.4 Capivasertib片 · No verified English nameJXHL2400101 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/05/09Import · Class 2.4 Capivasertib片 · No verified English nameJXHL2400100 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2024/05/09Generic · Class 3 Etoposide InjectionCYHS2401384 Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized
2024/05/09Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2401383 Jiangsu Ya Yao Bio Technology Co., Ltd. romanized; Anhui Feng Yuan Pharma Co., Ltd. romanized
2024/05/09Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2401382 Jiangsu Ya Yao Bio Technology Co., Ltd. romanized; Anhui Feng Yuan Pharma Co., Ltd. romanized
2024/05/09Generic · Class 3 Indocyaninegreen for InjectionCYHS2401375 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanized
2024/05/09Generic · Class 3 Trimebutine Maleate TabletsCYHS2401370 Hunan Nuo Na Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/05/09Generic · Class 3 Potassium Aspartate And Magnesium Aspartate InjectionCYHS2401369 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized
2024/05/09New drug · Class 1.1 蒿平颗粒 · No verified English nameCXZL2400024 Xin Qi Kang Pharma Co., Ltd. romanized; Xinjiang Qi Mu Pharmaceuticals Research Institute (Co., Ltd.) romanized
2024/05/09New drug · Class 3.3 乌司奴单抗注射液 · No verified English nameCXSS2400048 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/05/09New drug · Class 3.3 乌司奴单抗注射液(静脉输注) · No verified English nameCXSS2400047 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/05/09New drug · Class 3.3 乌司奴单抗注射液 · No verified English nameCXSS2400046 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/05/09New drug · Class 1 注射用CB-002 · No verified English nameCXSL2400297 Shanghai Mai Ke Si Biopharmaceuticals Co., Ltd. romanized
2024/05/09New drug · Class 1 LM-299注射液 · No verified English nameCXSL2400296 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/05/09New drug · Class 2.1; 2.2 泰它西普注射液 · No verified English nameCXSL2400295 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2024/05/09New drug · Class 1 KN069注射液 · No verified English nameCXSL2400294 Suzhou Kang Ning Jie Rui Bio Technology Co., Ltd. romanized
2024/05/09New drug · Class 3.3 德谷胰岛素注射液 · No verified English nameCXSL2400293 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/05/09New drug · Class 1 9MW2821 · No verified English nameCXSL2400292 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2024/05/09New drug · Class 1 注射用BL-M14D1 · No verified English nameCXSL2400291 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2024/05/09New drug · Class 3.3 23价肺炎球菌多糖疫苗 · No verified English nameCXSL2400290 Fu Xing An Te Jin (Chengdu) Biopharmaceutical Co., Ltd. romanized
2024/05/09New drug · Class 1 HP-001胶囊 · No verified English nameCXHL2400439 Shanghai Chao Yang Pharma Co., Ltd. romanized
2024/05/09New drug · Class 1 HP-001胶囊 · No verified English nameCXHL2400438 Shanghai Chao Yang Pharma Co., Ltd. romanized
2024/05/09New drug · Class 1 HP-001胶囊 · No verified English nameCXHL2400437 Shanghai Chao Yang Pharma Co., Ltd. romanized
2024/05/09New drug · Class 1 HRN01胶囊 · No verified English nameCXHL2400436 Beijing Hua Rui Ding Xin Technology Co., Ltd. romanized
2024/05/09New drug · Class 1 HRN01胶囊 · No verified English nameCXHL2400435 Beijing Hua Rui Ding Xin Technology Co., Ltd. romanized
2024/05/09New drug · Class 1 LW347片 · No verified English nameCXHL2400434 Shanghai Zhang Sen Pharma Co., Ltd. romanized
2024/05/09New drug · Class 1 LW347片 · No verified English nameCXHL2400433 Shanghai Zhang Sen Pharma 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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