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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 370 drug applications between 23 August 2023 and 29 August 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 47 drug names.

2023/08/23 – 2023/08/29

Period
2023/08/23 to 2023/08/29, 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
370
Drugs with new generic filings (by drug name, de-duplicated)
47
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

370filings, 62 of them generic

By application type

Application typeFilings
Supplement228
Generic62
New drug48
Unspecified11
Import11
Import re-registration10

By drug type

Drug typeFilings
Chemical drug240
TCM90
Therapeutic biologic34
Biologic3
Prophylactic 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

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Potassium Chloride Injection3210
2Tadalafil Tablets3123
3Rivaroxaban Tablets313
4Oseltamivir Phosphate For Oral Suspension222
5Montelukast Sodium Chewable Tablets214
6注射用头孢唑肟钠 · No verified English name214
7Nicorandil for Injection211
8Magnesium Sulfate Injection217
9Oseltamivir Phosphate Capsules2139
10Minoxidil Topical Solution210

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

190 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Xiu Zheng Pharma Group Tian Han Pharma Co., Ltd. romanized59540
2Guizhou Rui He Pharmaceutical Co., Ltd. romanized15150
3AstraZeneca AB730
4Celgene Corporation610
5GE Healthcare AS610
6Sanofi Winthrop Industrie610
7Sanofi-Aventis Deutschland GmbH550
8Novartis Europharm Limited520
9Qilu Pharmaceutical Co., Ltd.520
10Hainan Si Da Pharmaceutical Co., Ltd. romanized510

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

85 this week

AcceptedDrugApplicants
2023/08/29Import · Class 3.1 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300072 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2023/08/29Import · Class 3.1 四价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300071 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2023/08/29Generic · Class 3 Norepinephrine Bitartrate InjectionCYHS2302293 Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized
2023/08/29Generic · Class 3 Fludeoxyglucose[18F] InjectionCYHS2302290 Guangdong Xian Tong Fen Zi Ying Xiang Technology Co., Ltd. romanized
2023/08/29Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2302289 Hainan Brilliant Pharmaceutical Co., Ltd.
2023/08/29New drug · Class 2.3 桑枝总生物碱片 · No verified English nameCXZL2300054 Beijing Wu He Bo Ao Pharma Co., Ltd. romanized
2023/08/29New drug · Class 1 ALMB-0166注射液 · No verified English nameCXSL2300580 Shanghai En Le Mai Bio Technology Co., Ltd. romanized
2023/08/29New drug · Class 3.3 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2300579 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2023/08/29New drug · Class 1 QLR12018片 · No verified English nameCXHL2300924 Qilu Pharmaceutical Co., Ltd.
2023/08/29New drug · Class 1 QLR12018片 · No verified English nameCXHL2300923 Qilu Pharmaceutical Co., Ltd.
2023/08/29New drug · Class 1 QLR12018片 · No verified English nameCXHL2300922 Qilu Pharmaceutical Co., Ltd.
2023/08/29New drug · Class 1 QLR12018片 · No verified English nameCXHL2300921 Qilu Pharmaceutical Co., Ltd.
2023/08/29New drug · Class 1 YZJ-6097片 · No verified English nameCXHL2300920 Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized
2023/08/29New drug · Class 1 YZJ-6097片 · No verified English nameCXHL2300919 Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized
2023/08/29New drug · Class 2.4 硫酸锌片 · No verified English nameCXHL2300918 Beijing Hui Cheng Rui Xiang Pharmaceuticals Bio Technology Co., Ltd. romanized
2023/08/28New drug · Class 1.1 骨性关节炎软膏 · No verified English nameCXZL2300053 Yi Wu Shi Zhen Wei Zhong Cao Yao Technology Kai Fa Co., Ltd. romanized
2023/08/28New drug · Class 1 注射用BC001 · No verified English nameCXSL2300578 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized
2023/08/26Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2302279 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2023/08/26Generic · Class 3 Potassium Chloride InjectionCYHS2302276 Guangdong Ke Hong Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized
2023/08/26Generic · Class 3 Potassium Chloride InjectionCYHS2302275 Guangdong Ke Hong Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized
2023/08/26Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2302274 Guangdong Hong Shan Hu Pharma Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized
2023/08/26New drug · Class 1 SCG101自体T细胞注射液 · No verified English nameCXSL2300577 Xing Han De Biopharmaceuticals (Da Lian) Co., Ltd. romanized
2023/08/26New drug · Class 3.3 重组抗CTLA-4全人单克隆抗体注射液 · No verified English nameCXSL2300576 Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2023/08/26New drug · Class 1 IMP4297胶囊 · No verified English nameCXHS2300074 Shanghai Ying Pai Pharma Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2023/08/26New drug · Class 1 IMP4297胶囊 · No verified English nameCXHS2300073 Shanghai Ying Pai Pharma Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2023/08/26New drug · Class 1 SZJK-0421片 · No verified English nameCXHL2300917 Shenzhen Ji Kang Pharmaceuticals Technology Co., Ltd. romanized
2023/08/26New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2300916 Hua Run Shuang He Pharma Co., Ltd. romanized
2023/08/26New drug · Class 2.2 司美格鲁肽注射液 · No verified English nameCXHL2300915 Hua Run Shuang He Pharma Co., Ltd. romanized
2023/08/25Import · Class 1 AZD5335 · No verified English nameJXSL2300158 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/08/25Import · Class 1 AZD5305 · No verified English nameJXHL2300200 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.

55 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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