YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 265 drug applications between 30 May 2025 and 5 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 79, covering 56 drug names.

2025/05/30 – 2025/06/05

Period
2025/05/30 to 2025/06/05, 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
265
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
48

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

265filings, 79 of them generic

By application type

Application typeFilings
Supplement129
Generic79
New drug42
Import7
Import re-registration6
Unspecified2

By drug type

Drug typeFilings
Chemical drug165
TCM60
Therapeutic biologic36
Prophylactic biologic3
Biologic1

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

56 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acetylcysteine Injection4453
2Safinamide Methansulfonate Tablets4220
3Dapagliflozin Tablets4284
4Paliperidone Palmitate Injection318
5维生素B6注射液 · No verified English name2210
6Tadalafil Tablets2123
7利伐沙班颗粒 · No verified English name212
8复方氨基酸注射液(20AA-Ⅱ) · No verified English name210
9注射用头孢噻肟钠/氯化钠注射液 · No verified English name212
10Hydrocortisone Sodium Succinate for Injection2116

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

179 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized1060
2Guizhou Yi Bai Pharmaceutical Co., Ltd. romanized870
3Jiangxi Ke Rui Pharma Co., Ltd. romanized430
4Janssen-Cilag International NV420
5Li Zhu Group Li Zhu Pharmaceutical Factory romanized423
6Shaanxi Pan Long Pharma Group Co., Ltd. romanized420
7Liaoning Hai Shen Lian Sheng Pharmaceutical Co., Ltd. romanized410
8Jiangsu An Zheng Pharmaceutical Co., Ltd. romanized330
9Bai Ao Tai Biopharmaceutical Co., Ltd. romanized330
10Guizhou De Chang Xiang Pharmaceuticals Co., Ltd. romanized330

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

76 this week

AcceptedDrugApplicants
2025/06/05Generic · Class 3 注射用头孢噻肟钠/氯化钠注射液 · No verified English nameCYHS2501998 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/06/05Generic · Class 3 注射用头孢噻肟钠/氯化钠注射液 · No verified English nameCYHS2501997 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/06/05Generic · Class 3 多种微量元素注射液(Ⅰ) · No verified English nameCYHS2501992 Chengdu Giantech Hi-technology Development Co., Ltd.; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/06/05Generic · Class 3 Bifonazole SolutionCYHS2501987 Zhejiang Zhi Xin Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized
2025/06/05Generic · Class 3 Sodium Nitroprusside InjectionCYHS2501982 Shandong Qidu Pharmaceutical Co., Ltd.
2025/06/05Generic · Class 3 Sodium Nitroprusside InjectionCYHS2501981 Shandong Qidu Pharmaceutical Co., Ltd.
2025/06/05Generic · Class 3 Paracetamol and Ibuprofen TabletsCYHS2501980 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized
2025/06/05New drug · Class 2.1 15价肺炎球菌结合疫苗 · No verified English nameCXSS2500059 Beijing Zhi Fei Lv Zhu Biopharmaceutical Co., Ltd. romanized
2025/06/05New drug · Class 2.2 司普奇拜单抗注射液 · No verified English nameCXSL2500454 Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized
2025/06/05New drug · Class 1 SIBP-A10注射液 · No verified English nameCXSL2500449 Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized
2025/06/05New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2500448 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/06/05New drug · Class 2.1 替雷利珠单抗注射液(皮下注射) · No verified English nameCXSL2500447 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2025/06/05New drug · Class 1 KM1溶瘤痘苗病毒注射液 · No verified English nameCXSL2500446 Shenzhen Shi Hua Yao Kang Ming Bio Pharma Co., Ltd. romanized
2025/06/05New drug · Class 1 硫酸索美来昔片 · No verified English nameCXHS2500061 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized
2025/06/05New drug · Class 1 HB5凝胶 · No verified English nameCXHL2500536 Beijing Zhong Ke Xian Xing Medical Technology Co., Ltd. romanized; Zhongguo Ke College Li Hua Technology Research Institute romanized
2025/06/05New drug · Class 1 HB5凝胶 · No verified English nameCXHL2500535 Beijing Zhong Ke Xian Xing Medical Technology Co., Ltd. romanized; Zhongguo Ke College Li Hua Technology Research Institute romanized
2025/06/05New drug · Class 1 HB5凝胶 · No verified English nameCXHL2500534 Beijing Zhong Ke Xian Xing Medical Technology Co., Ltd. romanized; Zhongguo Ke College Li Hua Technology Research Institute romanized
2025/06/05New drug · Class 1 XC2309注射液 · No verified English nameCXHL2500533 Zhejiang Pharmaceuticals Co., Ltd. Xin Chang Pharmaceutical Factory romanized
2025/06/05New drug · Class 2.2 注射用硼[10B]法仑 · No verified English nameCXHL2500532 Zhong Zi Ke Xue (Chongqing) Research Institute Co., Ltd. romanized
2025/06/05New drug · Class 1 MDI-1228_mesylate凝胶 · No verified English nameCXHL2500531 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/06/05New drug · Class 1 MDI-1228_mesylate凝胶 · No verified English nameCXHL2500530 Mai Ying Nuo Pharmaceuticals Technology (Zhuhai) Co., Ltd. romanized
2025/06/04Import · Class 2.4 BMS-986165片 · No verified English nameJXHL2500124 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/06/04Import · Class 2.4 BMS-986165片 · No verified English nameJXHL2500123 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/06/04Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2501975 Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2025/06/04Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2501974 Mu Yuan (Anhui) Pharma Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2025/06/04Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2501972 Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized
2025/06/04Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2501966 Fujian Bo Yue Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd
2025/06/04Generic · Class 3 Minoxidil LinimentCYHS2501965 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2025/06/04Generic · Class 3 Lidocaine and Prilocaine Periodontal GelCYHL2500103 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/06/04New drug · Class 3.1 苓桂术甘颗粒 · No verified English nameCXZS2500024 Shen Wei Pharma Group Co., Ltd. romanized

46 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.