YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 400 drug applications between 1 December 2024 and 7 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 131, covering 94 drug names.
2024/12/01 – 2024/12/07
- New acceptances this week
- 400
- Drugs with new generic filings (by drug name, de-duplicated)
- 94
- Accepted this week, now under review
- 9
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
400filings, 131 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 177 |
| Generic | 131 |
| New drug | 64 |
| Import | 16 |
| Unspecified | 8 |
| Import re-registration | 3 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 257 |
| TCM | 72 |
| Therapeutic biologic | 61 |
| Biologic | 6 |
| Prophylactic biologic | 3 |
| In vitro diagnostic reagent | 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
94 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lactulose Oral Solution | 5 | 1 | 34 |
| 2 | Ambroxol Hydrochloride Oral Solution | 4 | 1 | 46 |
| 3 | Isavuconazonium Sulfate for Injection | 3 | 3 | 15 |
| 4 | Oxcarbazepine Extended-release Tablets | 3 | 1 | 0 |
| 5 | Procaterol Hydrochloride Granules | 3 | 1 | 2 |
| 6 | Levocarnitine Oral Solution | 2 | 2 | 9 |
| 7 | Polymyxin B sulfate for Injection | 2 | 2 | 6 |
| 8 | Sodium Hyaluronate Eye Drops | 2 | 2 | 30 |
| 9 | Progesterone Injection | 2 | 2 | 5 |
| 10 | Tadalafil Tablets | 2 | 1 | 23 |
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
244 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heilongjiang Sheng Bu Jia Tang Pharma Co., Ltd. romanized | 12 | 12 | 0 |
| 2 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 10 | 2 | 0 |
| 3 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 4 | Jiangxi Ke Lun Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 5 | Ningbo Ke Er Kang Mei Nuo Hua Pharma Co., Ltd. romanized | 5 | 5 | 5 |
| 6 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 5 | 4 | 1 |
| 7 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 5 | 4 | 5 |
| 8 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 | 5 |
| 9 | Ren He Yi Kang Group Co., Ltd. romanized | 5 | 2 | 2 |
| 10 | Shaanxi Xing Bang Pharma Co., Ltd. romanized | 5 | 1 | 5 |
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
124 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/07Import · Class 2.3 | 依柯胰岛素司美格鲁肽注射液 · No verified English nameJXSS2400110 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2024/12/07Import · Class 2.3 | 依柯胰岛素司美格鲁肽注射液 · No verified English nameJXSS2400109 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2024/12/07Import · Class 2.2 | 注射用玛贝兰妥单抗 · No verified English nameJXSS2400108 | GlaxoSmithKline Trading Services Limited; Glaxosmithkline Manufacturing S.p.A.; GlaxoSmithKline (China) Investment Co. Limited |
| 2024/12/07Import · Class 2.2 | 注射用玛贝兰妥单抗 · No verified English nameJXSS2400107 | GlaxoSmithKline Trading Services Limited; Glaxosmithkline Manufacturing S.p.A.; GlaxoSmithKline (China) Investment Co. Limited |
| 2024/12/07Import · Class 2.3 | 依柯胰岛素司美格鲁肽注射液 · No verified English nameJXSS2400106 | Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd. |
| 2024/12/07Import · Class 1 | 伊坦长效重组人生长激素注射液 · No verified English nameJXSS2400105 | YI-MAB BIOTECH HONG KONG LIMITED; PATHEON ITALIA S.P.A.; TJ Biopharma (Hangzhou) Co. Ltd. |
| 2024/12/07Import · Class 1 | 注射用MK-6070 · No verified English nameJXSL2400234 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd |
| 2024/12/07Import · Class 1 | 注射用MK-2400 · No verified English nameJXSL2400233 | Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd. |
| 2024/12/07Generic · Class 3 | Progesterone InjectionCYHS2404246 | Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2024/12/07Generic · Class 3 | Baclofen Oral SolutionCYHS2404238 | Shandong Dao Qi Biopharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized |
| 2024/12/07New drug · Class 1 | 注射用BL-M07D1 · No verified English nameCXSL2400836 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/12/07New drug · Class 1 | 注射用ZG005 · No verified English nameCXSL2400835 | Name not romanized; Name not romanized |
| 2024/12/07New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2400834 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/12/07New drug · Class 1 | IBI3002 · No verified English nameCXSL2400833 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/12/07New drug · Class 1 | HDM1005注射液 · No verified English nameCXHL2401330 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2024/12/07New drug · Class 1 | HDM1005注射液 · No verified English nameCXHL2401329 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2024/12/07New drug · Class 1 | HDM1005注射液 · No verified English nameCXHL2401328 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2024/12/07New drug · Class 1 | HDM1005注射液 · No verified English nameCXHL2401327 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2404234 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | 复方电解质醋酸钠葡萄糖注射液 · No verified English nameCYHS2404233 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Progesterone InjectionCYHS2404227 | Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jilin Ao Dong Pharma Group Yan Ji Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2404225 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2404224 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Terbutaline Sulfate InjectionCYHS2404218 | Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Jin Si Ming Bio Technology Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Indocyaninegreen for InjectionCYHS2404217 | Jiangsu Jiu Xu Pharma Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Terbutaline Sulfate InjectionCYHS2404216 | Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shaanxi Jin Si Ming Bio Technology Co., Ltd. romanized |
| 2024/12/06Generic · Class 3 | Sodium Cromoglicate Eye DropsCYHS2404207 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/12/06Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2400248 | Hua Run San Jiu (Ya An) Pharma Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | IBI3002 · No verified English nameCXSL2400832 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/12/06New drug · Class 1 | 注射用SLN12140 · No verified English nameCXSL2400831 | Ling Nuo (Shanghai) Pharmaceuticals Technology Co., Ltd. romanized |
94 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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