YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 372 drug applications between 6 September 2024 and 12 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 124, covering 85 drug names.
2024/09/06 – 2024/09/12
- New acceptances this week
- 372
- Drugs with new generic filings (by drug name, de-duplicated)
- 85
- Accepted this week, now under review
- 6
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
372filings, 124 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 170 |
| Generic | 124 |
| New drug | 67 |
| Import | 4 |
| Import re-registration | 4 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 269 |
| TCM | 63 |
| Therapeutic biologic | 36 |
| Prophylactic biologic | 2 |
| In vitro diagnostic reagent | 1 |
| Biologic | 1 |
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
85 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Levocetirizine dihydrochloride Oral Solution | 5 | 2 | 5 |
| 2 | Nicardipine Hydrochloride Injection | 4 | 2 | 13 |
| 3 | Acetylcysteine Solution For Inhalation | 3 | 3 | 4 |
| 4 | Lactulose Oral Solution | 3 | 2 | 34 |
| 5 | Trazodone Hydrochloride Tablets | 3 | 2 | 5 |
| 6 | Sodium Bicarbonate Injection | 3 | 2 | 10 |
| 7 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 8 | Erythromycin Lactobionate for Injection | 3 | 1 | 13 |
| 9 | 注射用头孢唑肟钠 · No verified English name | 3 | 1 | 4 |
| 10 | Bilastine Tablets | 2 | 2 | 7 |
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
235 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized | 15 | 14 | 0 |
| 2 | Gan Li Pharma Shandong Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Celgene Corporation | 6 | 1 | 0 |
| 4 | Suzhou Pai Rui Bio Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Anhui Pioneer Pharmaceutical Co., Ltd | 5 | 3 | 4 |
| 6 | Hua Run Shuang He Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 4 | 3 | 1 |
| 8 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 4 | 2 | 3 |
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
122 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/12Import · Class 1 | AZD2936 · No verified English nameJXSL2400165 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2024/09/12Import · Class 2.2 | 利司扑兰片 · No verified English nameJXHS2400063 | Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG; Roche (China) Holding Ltd. |
| 2024/09/12Generic · Class 3 | Bilastine Oral SolutionCYHS2403050 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2024/09/12Generic · Class 3 | 维生素B?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2403047 | Hebei Qiao Zhou Pharmaceuticals Technology Co., Ltd. romanized; Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized |
| 2024/09/12Generic · Class 3 | Levofloxacin Oral SolutionCYHS2403042 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2024/09/12Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2403037 | Hainan Bei Kang Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Tai Ping Yang Pharma Co., Ltd. romanized |
| 2024/09/12Generic · Class 3 | Pentoxifylline Modified Release TabletsCYHS2403035 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2024/09/12Generic · Class 3 | 盐酸西替利嗪滴眼液 · No verified English nameCYHL2400186 | Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | 植物源重组人血清白蛋白注射液 · No verified English nameCXSS2400098 | Wuhan He Yuan Bio Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 2 | 抗A抗B血型定型试剂(单克隆抗体) · No verified English nameCXSS2400097 | Changchun Bo Xun Bio Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 2.4 | 注射用重组人透明质酸酶 · No verified English nameCXSS2400096 | Shanghai Bao Ji Pharma Co., Ltd. romanized |
| 2024/09/12New drug · Class 2.4 | 注射用重组人透明质酸酶 · No verified English nameCXSS2400095 | Shanghai Bao Ji Pharma Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | EXG110注射液 · No verified English nameCXSL2400611 | Hangzhou Jia Yin Bio Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | 注射用TQB2102 · No verified English nameCXSL2400610 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | 注射用ZL-1310 · No verified English nameCXSL2400609 | Zai Ding Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | MWN105注射液 · No verified English nameCXSL2400608 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | MWN105注射液 · No verified English nameCXSL2400607 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | KH003注射液 · No verified English nameCXSL2400606 | Sai Ling Pharma Technology Group Co., Ltd. romanized; Beijing Sai Ling Zhi Guang Bio Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | MWN109注射液 · No verified English nameCXHL2400955 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | MWN109注射液 · No verified English nameCXHL2400954 | Shanghai Min Wei Bio Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | MAX-40279-01胶囊 · No verified English nameCXHL2400953 | Beijing Zai Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | MAX-40279-01胶囊 · No verified English nameCXHL2400952 | Beijing Zai Ji Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | SS-001 软膏 · No verified English nameCXHL2400951 | Suzhou Pai Rui Bio Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | SS-001 软膏 · No verified English nameCXHL2400950 | Suzhou Pai Rui Bio Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | SS-001 软膏 · No verified English nameCXHL2400949 | Suzhou Pai Rui Bio Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | CS060380片 · No verified English nameCXHL2400948 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | CS060380片 · No verified English nameCXHL2400947 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | CS060380片 · No verified English nameCXHL2400946 | Kai Si Kai Di (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | PR00012胶囊 · No verified English nameCXHL2400945 | Beijing Zhe Yuan Technology Co., Ltd. romanized |
| 2024/09/12New drug · Class 1 | PR00012胶囊 · No verified English nameCXHL2400944 | Beijing Zhe Yuan Technology Co., Ltd. romanized |
92 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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