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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 346 drug applications between 11 April 2024 and 17 April 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 75, covering 62 drug names.

2024/04/11 – 2024/04/17

Period
2024/04/11 to 2024/04/17, 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
346
Drugs with new generic filings (by drug name, de-duplicated)
62
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

346filings, 75 of them generic

By application type

Application typeFilings
Supplement163
Generic75
New drug67
Import17
Unspecified12
Import re-registration12

By drug type

Drug typeFilings
Chemical drug238
TCM60
Therapeutic biologic34
Prophylactic biologic8
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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution338
2Pamidronate Disodium Injection312
3Lidocaine and Prilocaine Cream2224
4氟比洛芬凝胶贴膏 · No verified English name2216
5Risperidone Orally Disintegrating Tablets210
6复方聚乙二醇电解质散(II) · No verified English name212
7Cefditoren Pivoxil Granules2118
8帕拉米韦氯化钠注射液 · No verified English name2117
9Caspofungin Acetate for Injection218
10Cytarabine for 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

210 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Yan Huang Ben Cao Pharma Co., Ltd. romanized10100
2Jiangsu Hao Sen Pharma Group Co., Ltd. romanized810
3Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized760
4Hua Jin (Chongqing) Pharma Co., Ltd. romanized610
5Boehringer Ingelheim International GmbH520
6Changchun Jin Sai Pharma Co., Ltd. romanized520
7Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized443
8Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized440
9BRIGHT FUTURE PHARMACEUTICAL LABORATORIES LIMITED430
10Zhang Zhou Pian Zai Huang Pharma Co., Ltd. romanized430

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

102 this week

AcceptedDrugApplicants
2024/04/17Import · Class 1 Amlitelimab注射液 · No verified English nameJXSL2400076 Scleroderma Research Foundation Inc.; Beijing Medpace Ltd.
2024/04/17Generic · Class 3 Epalrestat TabletsCYHS2401145 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2024/04/17Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2401142 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized
2024/04/17Generic · Class 3 Sodium Bicarbonate Ringer’s InjectionCYHS2401141 Zhejiang Kang Ji Er Pharma Co., Ltd. romanized
2024/04/17Generic · Class 3 Pamidronate Disodium InjectionCYHS2401138 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2024/04/17Generic · Class 3 Pamidronate Disodium InjectionCYHS2401137 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2024/04/17Generic · Class 3 Pamidronate Disodium InjectionCYHS2401136 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2024/04/17Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2401135 CISEN PHARMACEUTICAL CO., LTD.
2024/04/17Generic · Class 3 Methocarbamol InjectionCYHS2401134 Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/04/17Generic · Class 3 丙酸氟替卡松吸入粉雾剂 · No verified English nameCYHS2401133 Run Sheng Pharma Co., Ltd. romanized
2024/04/17Generic · Class 3 Foscarnet Sodium InjectionCYHS2401132 Gui Lin Nan Yao Co., Ltd. romanized; Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2024/04/17Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2401131 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2024/04/17New drug · Class 1.2 呼吸道合胞病毒mRNA疫苗 · No verified English nameCXSL2400244 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/04/17New drug · Class 1 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2400243 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2024/04/17New drug · Class 1 抗CD30嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2400242 Ming Hui (Nanjing) Ji Yin Bio Technology Co., Ltd. romanized
2024/04/17New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400241 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/04/17New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSL2400240 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/04/17New drug · Class 1 FL115注射液 · No verified English nameCXSL2400239 Suzhou Fu Rong Bio Technology Co., Ltd. romanized
2024/04/17New drug · Class 1 TQB2928注射液 · No verified English nameCXSL2400238 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/04/17New drug · Class 1 注射用BL-M17D1 · No verified English nameCXSL2400237 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2024/04/17New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2400394 Zhongguo Ke College Shanghai Drug Research Institute romanized; Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/04/17New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2400393 Zhongguo Ke College Shanghai Drug Research Institute romanized; Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/04/17New drug · Class 1 SYHA1813口服溶液 · No verified English nameCXHL2400392 Zhongguo Ke College Shanghai Drug Research Institute romanized; Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/04/17New drug · Class 2.4 海曲泊帕乙醇胺片 · No verified English nameCXHL2400391 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/04/17New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2400390 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2024/04/17New drug · Class 1 HJ787片 · No verified English nameCXHL2400389 Hua Jin (Chongqing) Pharma Co., Ltd. romanized
2024/04/17New drug · Class 1 HJ787片 · No verified English nameCXHL2400388 Hua Jin (Chongqing) Pharma Co., Ltd. romanized
2024/04/17New drug · Class 1 HJ787片 · No verified English nameCXHL2400387 Hua Jin (Chongqing) Pharma Co., Ltd. romanized
2024/04/17New drug · Class 1 HJ787片 · No verified English nameCXHL2400386 Hua Jin (Chongqing) Pharma Co., Ltd. romanized
2024/04/17New drug · Class 1 HJ787片 · No verified English nameCXHL2400385 Hua Jin (Chongqing) Pharma Co., Ltd. romanized

72 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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