YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 367 drug applications between 28 October 2024 and 3 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 69 drug names.

2024/10/28 – 2024/11/03

Period
2024/10/28 to 2024/11/03, 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
367
Drugs with new generic filings (by drug name, de-duplicated)
69
Accepted this week, now under review
2

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

367filings, 96 of them generic

By application type

Application typeFilings
Supplement189
Generic96
New drug57
Import12
Unspecified11
Import re-registration2

By drug type

Drug typeFilings
Chemical drug229
TCM90
Therapeutic biologic36
Biologic6
Prophylactic biologic6

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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets6360
2Doxofylline Tablets422
3Diquafosol Sodium Eye Drops335
4Oseltamivir Phosphate For Oral Suspension322
5Ampicillin Sodium and Sulbactam Sodium for Injection3113
6Metoclopramide Hydrochloride Injection226
7盐酸纳美芬注射液 · No verified English name221
8Potassium Aspartate And Magnesium Aspartate Injection223
9Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
10Obeticholic Acid Tablets210

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

219 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized21170
2Guangdong Sunho Pharmaceutical Co., Ltd.20160
3Novo Nordisk A/S1130
4Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized440
5Shaanxi Kang Hui Pharmaceutical Co., Ltd. romanized440
6Amgen Inc.420
7Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized330
8Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized330
9Xian Bei Lin Pharma Co., Ltd. romanized330
10Janssen-Cilag International NV320

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

109 this week

AcceptedDrugApplicants
2024/11/02Generic · Class 3 Phloroglucinol Orally Disintegrating TabletsCYHS2403744 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2024/11/02Generic · Class 3 Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2403743 Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
2024/11/02Generic · Class 3 Doxofylline TabletsCYHS2403742 Zhejiang Hua Yuan Pharma Co., Ltd. romanized
2024/11/02Generic · Class 3 Doxofylline TabletsCYHS2403741 Zhejiang Hua Yuan Pharma Co., Ltd. romanized
2024/11/02Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2403734 Ping Guang Pharmaceutical Co., Ltd. romanized
2024/11/02Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2403730 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2024/11/02New drug · Class 3.3 流感病毒裂解疫苗 · No verified English nameCXSS2400118 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2024/11/02New drug · Class 1 注射用HLX43 · No verified English nameCXSL2400747 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2024/11/02New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2401166 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/11/02New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2401165 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/11/02New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2401164 Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/11/02New drug · Class 2.3 HQ2303 · No verified English nameCXHL2401163 Bai Cheng Pharmaceuticals (Zhuhai Heng Qin) Co., Ltd. romanized
2024/11/02New drug · Class 1 注射用MB0151 · No verified English nameCXHL2401162 Zhu Liu Yuan Bio Technology (Shanghai) Co., Ltd. romanized; Zhong Shan Zhu Liu Yuan Bio Technology Co., Ltd. romanized
2024/11/02New drug · Class 2.1; 2.4 盐酸(R)-氯胺酮注射液 · No verified English nameCXHL2401161 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2024/11/02New drug · Class 1 SYHX1901片 · No verified English nameCXHL2401160 CSPC OUYI PHARMACEUTICAL CO., LTD.
2024/11/02New drug · Class 2.1; 2.4 盐酸(R)-氯胺酮注射液 · No verified English nameCXHL2401159 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2024/11/02New drug · Class 1 SYHX1901片 · No verified English nameCXHL2401158 CSPC OUYI PHARMACEUTICAL CO., LTD.
2024/11/02New drug · Class 2.2 BN020827H · No verified English nameCXHL2401157 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized
2024/11/01Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSL2400211 Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2024/11/01Import · Class 1 PIT565 · No verified English nameJXSL2400210 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2024/11/01Import · Class 3.1 13价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2400209 Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd.
2024/11/01Import · Class 2.4 BMS-986165片 · No verified English nameJXHL2400262 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2024/11/01Import · Class 2.4 BMS-986165片 · No verified English nameJXHL2400261 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2024/11/01Import · Class 2.4 BMS-986165片 · No verified English nameJXHL2400260 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2024/11/01Generic · Class 3 Multiple Electrolyte Additive For InjectionCYHS2403726 Henan Shang Heng Pharmaceuticals Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized
2024/11/01Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2403723 Gansu Nong Ken Drug Jian Factory Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized
2024/11/01Generic · Class 3 Lorazepam TabletsCYHS2403722 Beijing Yi Min Pharma Co., Ltd. romanized
2024/11/01Generic · Class 3 Progesterone InjectionCYHS2403721 Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized
2024/11/01Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2403718 Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized
2024/11/01Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2403717 Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized

79 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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