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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 411 drug applications between 3 August 2024 and 9 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 124, covering 87 drug names.

2024/08/03 – 2024/08/09

Period
2024/08/03 to 2024/08/09, 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
411
Drugs with new generic filings (by drug name, de-duplicated)
87
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

411filings, 124 of them generic

By application type

Application typeFilings
Supplement186
Generic124
New drug48
Import24
Unspecified17
Import re-registration12

By drug type

Drug typeFilings
Chemical drug289
TCM60
Therapeutic biologic45
Biologic9
Prophylactic biologic8

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

87 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1生理氯化钠溶液 · No verified English name5117
2Cefoperazone Sodium and Sulbactam Sodium for Injection4214
3Bisoprolol Fumarate and Amlodipine Besylate Tablets339
4Sacubitril Valsartan Sodium Tablets3170
5Metformin Hydrochloride Extended-release Tablets3110
6Pioglitazone and Metformin Hydrochloride Tablets2210
7氯化钙注射液 · No verified English name226
8Hydrotalcite Chewable Tablets226
9Irbesartan Tablets214
10Diclofenac Diethylamine Emulgel2120

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

242 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Boehringer Ingelheim International GmbH1520
2Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized810
3Shenyang Hong Yao Group Co., Ltd. romanized770
4Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized730
5Hunan San Xue Pharma Co., Ltd. romanized650
6Novo Nordisk A/S620
7Qilu Pharmaceutical Co., Ltd.543
8Hebei Dao En Pharma Co., Ltd. romanized515
9Shanghai Wan Shi Cheng Pharma Co., Ltd. romanized440
10Shandong Qidu Pharmaceutical Co., Ltd.444

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

129 this week

AcceptedDrugApplicants
2024/08/09Import · Class 2.4 艾伏尼布片 · No verified English nameJXHL2400198 Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development Co. LTD
2024/08/09Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2402578 Shanghai Xuan Xin Pharmaceuticals Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2024/08/09Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2402577 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/08/09Generic · Class 3 枸橼酸西地那非口溶膜 · No verified English nameCYHS2402576 Sichuan Kelun Pharmaceutical Co., Ltd.
2024/08/09Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2402575 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2402574 Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2402573 Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2402572 Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2402571 Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2402570 Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 维生素K滴剂 · No verified English nameCYHS2402569 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Wei Kang Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2402559 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2402545 Hainan Ai Ke Pharmaceutical Co., Ltd. romanized
2024/08/09Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2402544 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2024/08/09Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2402543 Hainan Huluwa Pharmaceutical Group Co., Ltd.
2024/08/09Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2402540 Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2024/08/09Generic · Class 3 Enzalutamide TabletsCYHS2402539 Ao Rui Te Pharma Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 Enzalutamide TabletsCYHS2402538 Ao Rui Te Pharma Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2024/08/09Generic · Class 3 Potassium Phosphates InjectionCYHS2402537 Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized
2024/08/09Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2402536 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized
2024/08/09Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2402535 Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized
2024/08/09Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2400163 Beijing Foyou Pharma CO.,LTD
2024/08/09Generic · Class 3 酮洛芬凝胶贴膏 · No verified English nameCYHL2400162 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2024/08/09New drug · Class 1.3 四价流感重组蛋白疫苗 · No verified English nameCXSL2400528 Guangdong Hua Nan Yi Miao Co., Ltd. romanized
2024/08/09New drug · Class 1 IBI3001 · No verified English nameCXSL2400527 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/08/09New drug · Class 1 注射用DNV3 · No verified English nameCXSL2400526 Zhejiang Shi Mai Pharma Co., Ltd. romanized
2024/08/09New drug · Class 1 HRS-5041片 · No verified English nameCXHL2400808 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/08/09New drug · Class 1 HRS-5041片 · No verified English nameCXHL2400807 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/08/09New drug · Class 1 HRS-1358片 · No verified English nameCXHL2400806 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2024/08/09New drug · Class 1 HRS-1358片 · No verified English nameCXHL2400805 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized

99 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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