YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 279 drug applications between 3 June 2022 and 9 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 34, covering 22 drug names.
2022/06/03 – 2022/06/09
- New acceptances this week
- 279
- Drugs with new generic filings (by drug name, de-duplicated)
- 22
- Accepted this week, now under review
- 0
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
279filings, 34 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 164 |
| New drug | 43 |
| Generic | 34 |
| Import | 26 |
| Unspecified | 7 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 164 |
| Therapeutic biologic | 60 |
| TCM | 48 |
| Prophylactic biologic | 4 |
| Biologic | 3 |
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
22 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Atomoxetine Hydrochloride Capsules | 7 | 1 | 6 |
| 2 | Olanzapine Tablets | 3 | 1 | 4 |
| 3 | 复方聚乙二醇电解质散(Ⅲ) · No verified English name | 2 | 2 | 1 |
| 4 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 5 | Rocuronium Bromide Injection | 2 | 1 | 1 |
| 6 | 阿普米司特片 · No verified English name | 2 | 1 | 3 |
| 7 | 复方聚乙二醇电解质散(III) · No verified English name | 1 | 1 | 3 |
| 8 | Flurbiprofen Sodium Eye Drops | 1 | 1 | 5 |
| 9 | 泊沙康唑注射液 · No verified English name | 1 | 1 | 1 |
| 10 | Sodium Hyaluronate Eye Drops | 1 | 1 | 30 |
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
150 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanghai Lai Shi Xue Ye Zhi Pin Co., Ltd. romanized | 20 | 6 | 0 |
| 2 | Changchun Hai Wai Pharmaceutical Group Co., Ltd. romanized | 10 | 8 | 0 |
| 3 | Zhejiang Ao Tuo Kang Pharmaceuticals Technology Co., Ltd. romanized | 9 | 7 | 0 |
| 4 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 8 | 8 | 0 |
| 5 | Jilin Rui Long Pharma Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 7 | 1 | 7 |
| 7 | Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Novartis Pharma AG | 6 | 2 | 0 |
| 9 | Guangxi Ji Min Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | F. Hoffmann-La Roche Ltd | 4 | 3 | 0 |
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
68 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/06/09Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2200075 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/06/09Import · Class 2.2 | 古塞奇尤单抗注射液 · No verified English nameJXSL2200074 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/06/09Import · Class 1 | CHF6001吸入粉雾剂 · No verified English nameJXHL2200136 | Chiesi Farmaceutici S.p.A.; ICON Clinical Research (Beijing No.2) Co. Ltd. |
| 2022/06/09Import · Class 1 | CHF6001吸入粉雾剂 · No verified English nameJXHL2200135 | Chiesi Farmaceutici S.p.A.; ICON Clinical Research (Beijing No.2) Co. Ltd. |
| 2022/06/09Import · Class 1 | LNP023胶囊 · No verified English nameJXHL2200134 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/06/09Generic · Class 3 | 芬太尼透皮贴剂(II) · No verified English nameCYHL2200047 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/06/09New drug · Class 3.3 | 利拉鲁肽注射液 · No verified English nameCXSS2200058 | Tong Hua Dong Bao Pharma Co., Ltd. romanized |
| 2022/06/09New drug · Class 3.4 | 人生长激素注射液 · No verified English nameCXSS2200057 | Zhong Shan Wei Ming Hai Ji Biopharmaceuticals Co., Ltd. romanized |
| 2022/06/09New drug · Class 3.4 | 人生长激素注射液 · No verified English nameCXSS2200056 | Zhong Shan Wei Ming Hai Ji Biopharmaceuticals Co., Ltd. romanized |
| 2022/06/09New drug · Class 1 | TX103嵌合抗原受体T细胞注射液 · No verified English nameCXSL2200258 | Fuzhou Tuo Xin Tian Cheng Bio Technology Co., Ltd. romanized |
| 2022/06/09New drug · Class 1 | QL1604注射液 · No verified English nameCXSL2200257 | Qilu Pharmaceutical Co., Ltd. |
| 2022/06/09New drug · Class 3.2 | 阿基仑赛注射液 · No verified English nameCXSL2200256 | Fu Xing Kai Te Bio Technology Co., Ltd. romanized |
| 2022/06/09New drug · Class 1 | B013注射液 · No verified English nameCXSL2200255 | Shanghai Jiao Lian Drug Research and Development Co., Ltd. romanized |
| 2022/06/09New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2200254 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2022/06/09New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2200253 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2022/06/09New drug · Class 1 | 注射用FDA022抗体偶联剂 · No verified English nameCXSL2200252 | Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized |
| 2022/06/09New drug · Class 2.2 | 环孢素眼用凝胶 · No verified English nameCXHS2200033 | Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized |
| 2022/06/09New drug · Class 1 | HRS-9821吸入混悬液 · No verified English nameCXHL2200365 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/06/09New drug · Class 2.2 | 纳曲酮植入剂 · No verified English nameCXHL2200364 | Shenzhen Shan Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/06/09New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2200363 | Le Pu Pharma Co., Ltd. romanized |
| 2022/06/09New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2200362 | Le Pu Pharma Co., Ltd. romanized |
| 2022/06/08Import · Class 1 | PM1016注射液 · No verified English nameJXSL2200073 | TILT Biotherapeutics Ltd.; Biotheus Inc. |
| 2022/06/08Import · Class 1 | 吸入用Ensifentrine混悬液 · No verified English nameJXHL2200133 | Verona Pharma plc; Nuance Pharma (Shanghai) Co. Ltd. |
| 2022/06/08New drug · Class 1 | QL1706注射液 · No verified English nameCXSL2200251 | Qilu Pharmaceutical Co., Ltd. |
| 2022/06/08New drug · Class 1 | PM8002注射液 · No verified English nameCXSL2200250 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2022/06/08New drug · Class 1 | 重组抗HER2人源化HuA21单克隆抗体注射液 · No verified English nameCXSL2200249 | Hefei Han Ke Mai Bo Bio Technology Co., Ltd. romanized |
| 2022/06/08New drug · Class 2.4 | 甲磺酸伏美替尼片 · No verified English nameCXHL2200361 | Shanghai Ai Li Si Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/06/07Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2200071 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/06/07New drug · Class 1 | 注射用DB-1305 · No verified English nameCXSL2200248 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2022/06/07New drug · Class 1 | ASKB589注射液 · No verified English nameCXSL2200247 | Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized |
38 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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