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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 352 drug applications between 20 May 2023 and 26 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 44 drug names.

2023/05/20 – 2023/05/26

Period
2023/05/20 to 2023/05/26, 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
352
Drugs with new generic filings (by drug name, de-duplicated)
44
Accepted this week, now under review
3

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

352filings, 70 of them generic

By application type

Application typeFilings
Supplement192
Generic70
New drug59
Import re-registration18
Import7
Unspecified6

By drug type

Drug typeFilings
Chemical drug247
TCM62
Therapeutic biologic38
Prophylactic biologic4
In vitro diagnostic reagent1

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

44 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Roxadustat Capsules12617
2Ropivacaine hydrochloride injection415
3Minoxidil Topical Solution320
4Sildenafil Citrate Tablets3112
5Carfilzomib For Injection310
6Oxacillin Sodium for Injection3113
7Phloroglucinol Injection222
8Nicorandil for Injection211
9盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212
10Naloxone Hydrochloride Injection211

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

196 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Lang De Pharma Co., Ltd. romanized32140
2Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized12110
3UCB Pharma SA610
4Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized610
5Guang Sheng Yuan Zhong Pharmaceuticals Co., Ltd. romanized530
6Xiu Zheng Pharma Group Lin Yi Xiu Zheng Pharmaceutical Co., Ltd. romanized440
7AstraZeneca AB420
8Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized420
9Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized424
10Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized421

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

88 this week

AcceptedDrugApplicants
2023/05/26Generic · Class 3 Minoxidil Topical SolutionCYHS2301430 Jiangsu Run Bang Pharma Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/05/26Generic · Class 3 Minoxidil Topical SolutionCYHS2301429 Jiangsu Run Bang Pharma Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2023/05/26Generic · Class 3 Fluorouracil InjectionCYHS2301428 Hunan Sai Long Pharma (Changsha) Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized
2023/05/26Generic · Class 3 Pregabalin Oral SolutionCYHS2301427 Haerbin Shi Kang Long Pharma Co., Ltd. romanized
2023/05/26Generic · Class 3 Haloperidol Lactate InjectionCYHS2301426 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/05/26New drug · Class 1.1 麻荆宣肺颗粒 · No verified English nameCXZL2300037 Zhongguo Zhong Yi Ke College Xi Yuan Hospital romanized
2023/05/26New drug · Class 1.4 口服六价重配轮状病毒活疫苗(Vero细胞) · No verified English nameCXSS2300039 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/05/26New drug · Class 2.2 四价流感病毒亚单位疫苗(MDCK细胞) · No verified English nameCXSL2300376 Changchun Bio Zhi Pin Research Institute Co., Ltd. romanized
2023/05/26New drug · Class 3.2 人纤溶酶原 · No verified English nameCXSL2300375 Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized
2023/05/26New drug · Class 1 KQ-2003自体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2300374 Shanghai Ke Qi Pharma Technology Co., Ltd. romanized
2023/05/26New drug · Class 1 JY03注射液 · No verified English nameCXSL2300373 Beijing Dong Fang Bai Tai Bio Technology Co., Ltd. romanized; Beijing Jing Yi Tai Xiang Technology Development Co., Ltd. romanized
2023/05/26New drug · Class 1 YH2000片 · No verified English nameCXHL2300580 Wuhan Shi Jin Nuo Sai Biopharmaceuticals Co., Ltd. romanized
2023/05/25Import · Class 2.2; 2.1 佩索利单抗注射液(皮下注射) · No verified English nameJXSS2300039 Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer Ingelheim (China) Investment Co. Ltd.
2023/05/25Import · Class 1 Olorofim片 · No verified English nameJXHL2300123 Shionogi & Co. Ltd.; Ping An-Shionogi Co. Ltd.
2023/05/25Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2301414 Anhui Shuang He Pharma Co., Ltd. romanized
2023/05/25New drug · Class 3.1 济川颗粒 · No verified English nameCXZS2300011 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2023/05/25New drug · Class 3.3 吸附破伤风疫苗 · No verified English nameCXSL2300372 Kang Xi Nuo Bio Shareholding Company romanized
2023/05/25New drug · Class 1 VC004胶囊 · No verified English nameCXHL2300579 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2023/05/25New drug · Class 1 VC004胶囊 · No verified English nameCXHL2300578 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2023/05/24Generic · Class 3 聚乙二醇3350散 · No verified English nameCYHS2301409 Haerbin Kui Hua Pharma Co., Ltd. romanized; Kui Hua Pharma Group (Tang Shan) Biopharmaceutical Co., Ltd. romanized
2023/05/24Generic · Class 3 Diprophylline InjectionCYHS2301408 Shaanxi Li Cai Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2023/05/24Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2301406 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/05/24Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2301405 Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/05/24Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301404 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized
2023/05/24Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301403 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized
2023/05/24Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301402 Shandong Jing Hui Bio Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized
2023/05/24New drug · Class 3.3 帕妥珠单抗注射液 · No verified English nameCXSS2300038 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/05/24New drug · Class 1 注射用BRII-877(VIR-3434) · No verified English nameCXSL2300371 Teng Sheng Bo Yao Pharmaceuticals Technology (Beijing) Co., Ltd. romanized
2023/05/24New drug · Class 1 FT-003注射液 · No verified English nameCXSL2300370 Fang Tuo Bio Technology (Suzhou) Co., Ltd. romanized
2023/05/24New drug · Class 1 RC148注射液 · No verified English nameCXSL2300369 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized

58 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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