YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 356 drug applications between 13 June 2025 and 19 June 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 74 drug names.

2025/06/13 – 2025/06/19

Period
2025/06/13 to 2025/06/19, 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
356
Drugs with new generic filings (by drug name, de-duplicated)
74
Accepted this week, now under review
55

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

356filings, 92 of them generic

By application type

Application typeFilings
Supplement173
Generic92
New drug43
Import37
Unspecified7
Import re-registration3
Medical device (joint review)1

By drug type

Drug typeFilings
Chemical drug212
TCM72
Therapeutic biologic64
Biologic4
Prophylactic biologic3
Unspecified1

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

74 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2Escitalopram Oxalate Tablets316
3Upadacitinib Sustained-release Tablets2243
4Acetylcysteine Injection2253
5Acetylcysteine Oral Solution2111
6Perindopril tert-Butylamine Tablets215
7Lacidipine Tablets217
8Pregabalin Capsules2112
9Sacubitril Valsartan Sodium Tablets2170
10Penehyclidine Hydrochloride Injection212

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

212 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Henan Ying Feng Pharmaceuticals Co., Ltd. romanized880
2Amgen Inc.820
3Novo Nordisk A/S820
4Pfizer Inc.740
5Lai Yang Si Bang De Pharmaceutical Co., Ltd. romanized550
6Yunnan Jin Ke Pharmaceutical Co., Ltd. romanized540
7Huayi Pharmaceuticals (Anhui) Co., Ltd.535
8Jiangsu Zhong Xin Pharmaceuticals Co., Ltd. romanized510
9Fujian Ji Nuo Hou Pu Bio Technology Co., Ltd. romanized510
10Jilin Sheng Qi Ke Pharma Co., Ltd. romanized440

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

106 this week

AcceptedDrugApplicants
2025/06/19Import · Class 2.4 紫杉醇口服溶液 · No verified English nameJXHS2500073 DAEHWA PHARMACEUTICAL CO.,LTD.; Haihe Biopharma Co. Ltd
2025/06/19Import · Class 2.4 紫杉醇口服溶液 · No verified English nameJXHS2500072 DAEHWA PHARMACEUTICAL CO.,LTD.; Haihe Biopharma Co. Ltd
2025/06/19Import · Class 2.4 紫杉醇口服溶液 · No verified English nameJXHS2500071 DAEHWA PHARMACEUTICAL CO.,LTD.; Haihe Biopharma Co. Ltd
2025/06/19Import · Class 1 Centanafadine持释胶囊 · No verified English nameJXHL2500152 Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute
2025/06/19Import · Class 1 Centanafadine持释胶囊 · No verified English nameJXHL2500151 Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute
2025/06/19Import · Class 1 Centanafadine持释胶囊 · No verified English nameJXHL2500150 Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Institute
2025/06/19Generic · Class 3 Foscarnet Sodium InjectionCYHS2502204 Hainan Ru Kang Bio Technology Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized
2025/06/19New drug · Class 3.3 SYS6036注射液 · No verified English nameCXSL2500500 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2025/06/19New drug · Class 1 HX001注射液 · No verified English nameCXSL2500499 Wuhan Hou Xian Biopharmaceuticals Co., Ltd. romanized
2025/06/19New drug · Class 1 丁二酸复瑞替尼胶囊 · No verified English nameCXHL2500591 Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized
2025/06/19New drug · Class 2.2 雷美替胺双释片 · No verified English nameCXHL2500590 Nanjing San Die Ji Pharmaceuticals Technology Co., Ltd. romanized
2025/06/18Import · Class 2.2 DS-1062a · No verified English nameJXSL2500102 Daiichi Sankyo Inc.
2025/06/18Import · Class 2.2 注射用德曲妥珠单抗 · No verified English nameJXSL2500101 Daiichi Sankyo Inc.; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD.
2025/06/18Import · Class 2.2 比奇珠单抗注射液 · No verified English nameJXSL2500100 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2025/06/18Import · Class 2.2 比奇珠单抗注射液 · No verified English nameJXSL2500099 UCB Pharma S.A.; UCB Trading (Shanghai) Co. Ltd
2025/06/18Import · Class 2.1 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2500098 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2025/06/18Import · Class 2.1 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2500097 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.?
2025/06/18Import · Class 1 PF-07248144片 · No verified English nameJXHL2500149 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/06/18Import · Class 1 PF-07248144片 · No verified English nameJXHL2500148 Pfizer Inc.; Pfizer Investment CO. Ltd.
2025/06/18Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2502194 Guangzhou Han Guang Pharma Co., Ltd. romanized; Tian Da Pharma (Zhuhai) Co., Ltd. romanized
2025/06/18Generic · Class 3 Sodium Thiosulfate InjectionCYHS2502193 Zhong Run Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized
2025/06/18Generic · Class 3 Sodium Thiosulfate InjectionCYHS2502192 Zhong Run Pharma Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized
2025/06/18Generic · Class 3 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2502188 Guangzhou Nan Xin Pharmaceutical Co., Ltd. romanized
2025/06/18Generic · Class 3 Peramivir InjectionCYHS2502187 Hainan Hui Pu Sen Pharmaceuticals Bio Technology Co., Ltd. romanized
2025/06/18Generic · Class 3 聚乙二醇4000散(儿童型) · No verified English nameCYHS2502186 Hainan Yun Ding Pharmaceuticals Technology Co., Ltd. romanized; Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized
2025/06/18Generic · Class 3 Eltrombopag Lamine For Oral SuspensionCYHS2502182 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2025/06/18Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2502177 Hefei Ying Tai Pharmaceutical Co., Ltd. romanized
2025/06/18Generic · Class 3 Trazodone Hydrochloride TabletsCYHS2502176 Hefei Ying Tai Pharmaceutical Co., Ltd. romanized
2025/06/18Generic · Class 3 Sodium Nitroprusside InjectionCYHS2502175 Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized
2025/06/18Generic · Class 3 盐酸纳美芬注射液 · No verified English nameCYHS2502174 Shijiazhuang No.4 Pharmaceutical Co., Ltd.

76 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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