YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 266 drug applications between 12 March 2026 and 18 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 31, covering 25 drug names.
2026/03/12 – 2026/03/18
- New acceptances this week
- 266
- Drugs with new generic filings (by drug name, de-duplicated)
- 25
- Accepted this week, now under review
- 57
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
266filings, 31 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| New drug | 55 |
| Generic | 31 |
| Import | 12 |
| Unspecified | 8 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 145 |
| TCM | 83 |
| Therapeutic biologic | 34 |
| Biologic | 4 |
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
25 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 达普司他片 · No verified English name | 3 | 1 | 0 |
| 2 | Crizotinib Capsules | 2 | 1 | 7 |
| 3 | Isosorbide Mononitrate Extended-Release Tablets | 2 | 1 | 5 |
| 4 | 注射用阿立哌唑 · No verified English name | 2 | 1 | 4 |
| 5 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
| 6 | Lactulose Oral Solution | 1 | 1 | 34 |
| 7 | Lidocaine Cataplasms | 1 | 1 | 7 |
| 8 | Furosemide Injection | 1 | 1 | 6 |
| 9 | Compound Glycyrrhizin Tablets | 1 | 1 | 7 |
| 10 | Cefditoren Pivoxil Granules | 1 | 1 | 18 |
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
156 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangxi Pu Li Er Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 2 | Heilongjiang Sheng Song Hua Jiang Pharmaceuticals Technology Co., Ltd. romanized | 7 | 7 | 0 |
| 3 | Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Zhang Feng Su Yue Pharma (Guangzhou) Co., Ltd. romanized | 6 | 1 | 0 |
| 5 | Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Karuna Therapeutics Inc. | 5 | 1 | 0 |
| 7 | Ke Xing Biopharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 8 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Janssen Research & Development LLC | 4 | 3 | 0 |
| 10 | Qilu Pharmaceutical Co., Ltd. | 4 | 3 | 2 |
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
76 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/18Import · Class 1 | JNJ-79635322 · No verified English nameJXSL2600082 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/03/18Import · Class 1 | JNJ-79635322 · No verified English nameJXSL2600081 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/03/18Generic · Class 3 | Tranexamic Acid and Sodium Chloride InjectionCYHS2600670 | Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized |
| 2026/03/18New drug · Class 1 | 注射用QLS5133 · No verified English nameCXSL2600335 | Qilu Pharmaceutical Co., Ltd. |
| 2026/03/17Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2600085 | Eli Lillly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/03/17Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2600084 | Eli Lillly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/03/17Import · Class 1 | Brenipatide注射液 · No verified English nameJXHL2600083 | Eli Lillly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2026/03/17New drug · Class 2.4 | 注射用盐酸曲拉西利 · No verified English nameCXHL2600334 | Xian Sheng Zai Ming Pharmaceuticals Co., Ltd. romanized |
| 2026/03/17New drug · Class 2.4 | 注射用盐酸曲拉西利 · No verified English nameCXHL2600333 | Xian Sheng Zai Ming Pharmaceuticals Co., Ltd. romanized |
| 2026/03/17New drug · Class 2.4 | 利厄替尼片 · No verified English nameCXHL2600332 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized |
| 2026/03/17New drug · Class 1 | 注射用DN022150 · No verified English nameCXHL2600331 | Jiangxi Ke Rui Pharma Co., Ltd. romanized |
| 2026/03/17New drug · Class 1 | LNK01004软膏 · No verified English nameCXHL2600330 | Ling Ke Pharma (Zhejiang) Co., Ltd. romanized |
| 2026/03/17New drug · Class 1 | LNK01004软膏 · No verified English nameCXHL2600329 | Ling Ke Pharma (Zhejiang) Co., Ltd. romanized |
| 2026/03/16New drug · Class 1 | ASKC202片 · No verified English nameCXHL2600328 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized |
| 2026/03/16New drug · Class 1 | ASKC202片 · No verified English nameCXHL2600327 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized |
| 2026/03/14Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600022 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/03/14Import · Class 3.1 | 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600021 | Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd |
| 2026/03/14Import · Class 2.2 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2600079 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2026/03/14Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2600665 | Zhejiang Ling Chuang You Pin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2026/03/14Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2600664 | Jiangxi Sheng Xiang Pharmaceutical Co., Ltd. romanized |
| 2026/03/14Generic · Class 3 | Simethicone Chewable TabletsCYHS2600662 | Hebei Hua Chen Pharma Group Co., Ltd. romanized |
| 2026/03/14Generic · Class 3 | 达普司他片 · No verified English nameCYHL2600036 | Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized |
| 2026/03/14Generic · Class 3 | 达普司他片 · No verified English nameCYHL2600035 | Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized |
| 2026/03/14Generic · Class 3 | 达普司他片 · No verified English nameCYHL2600034 | Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized |
| 2026/03/14New drug · Class 1 | 舒地胰岛素诺利糖肽注射液 · No verified English nameCXSS2600049 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/03/14New drug · Class 1 | 舒地胰岛素诺利糖肽注射液 · No verified English nameCXSS2600048 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/03/14New drug · Class 1 | BTL-101注射液 · No verified English nameCXSL2600331 | Ben Dao Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2026/03/14New drug · Class 2.2 | 注射用重组葡激酶 · No verified English nameCXSL2600330 | Tong Hua Kang Yuan Yu Jin Pharma Co., Ltd. romanized |
| 2026/03/14New drug · Class 1 | 富马酸立康可泮胶囊 · No verified English nameCXHS2600042 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/03/13Import · Class 1 | Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600078 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
46 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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