YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 305 drug applications between 15 September 2022 and 21 September 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 47 drug names.
2022/09/15 – 2022/09/21
- New acceptances this week
- 305
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- 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
305filings, 65 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 159 |
| Generic | 65 |
| New drug | 53 |
| Import | 14 |
| Unspecified | 9 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 227 |
| TCM | 42 |
| Therapeutic biologic | 32 |
| 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
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapagliflozin And Metformin Hydrochloride Extended-Release Tablets | 5 | 1 | 0 |
| 2 | Indobufen Tablets | 3 | 2 | 6 |
| 3 | Oseltamivir Phosphate For Oral Suspension | 3 | 2 | 2 |
| 4 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 5 | Nintedanib Esilate Soft Capsules | 2 | 1 | 6 |
| 6 | Tandospirone Citrate Tablets | 2 | 1 | 2 |
| 7 | Tranexamic Acid Injection | 2 | 1 | 11 |
| 8 | Teicoplanin for Injection | 2 | 1 | 6 |
| 9 | Hydrocortisone Sodium Succinate for Injection | 2 | 1 | 16 |
| 10 | Doxorubicin Hydrochloride Liposome Injection | 2 | 1 | 2 |
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
173 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shanghai Yan An Pharma Co., Ltd. romanized | 12 | 11 | 0 |
| 2 | Guangxi Jin Xing Industrial Co., Ltd. romanized | 10 | 6 | 0 |
| 3 | Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 8 | 6 | 0 |
| 4 | Da Lian Tian Shan Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Actelion Pharmaceuticals Ltd | 6 | 2 | 0 |
| 6 | Jiangxi Ke Rui Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 8 | Sanofi -aventis France | 5 | 1 | 0 |
| 9 | Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 5 |
| 10 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 4 | 4 | 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
98 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/09/21Import · Class 2.2 | 注射用Tafasitamab · No verified English nameJXSL2200168 | Incyte Biosciences Distribution B.V.; Beijing InnoCare Pharma Tech Co. Ltd. |
| 2022/09/21Import · Class 1 | LEO 152020 薄膜包衣片 · No verified English nameJXHL2200289 | LEO Pharma A/S; LEO Pharma Consultany(Shanghai) company Limited |
| 2022/09/21Import · Class 1 | 注射用TNP-2092 · No verified English nameJXHL2200288 | TenNor Therapeutics Inc.; TenNor (Suzhou) Therapeutics Limited |
| 2022/09/21Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2201577 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2022/09/21Generic · Class 3 | Cilostazol TabletsCYHS2201576 | Beijing Foyou Pharma CO.,LTD |
| 2022/09/21Generic · Class 3 | Indobufen TabletsCYHS2201574 | Zhejiang Mei Di Shen Biopharmaceuticals Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized |
| 2022/09/21New drug · Class 1.2 | 枳实总黄酮苷提取物 · No verified English nameCXZS2200009 | Jiangxi Qing Feng Pharma Co., Ltd. romanized |
| 2022/09/21New drug · Class 1.2 | 奥兰替胃康片 · No verified English nameCXZS2200008 | Jiangxi Qing Feng Pharma Co., Ltd. romanized |
| 2022/09/21New drug · Class 1 | 注射用 TQB2102 · No verified English nameCXSL2200472 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2022/09/21New drug · Class 3.4 | 人凝血酶 · No verified English nameCXSL2200471 | Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized |
| 2022/09/21New drug · Class 3.4 | 人凝血酶 · No verified English nameCXSL2200470 | Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized |
| 2022/09/21New drug · Class 3.4 | 人凝血酶 · No verified English nameCXSL2200469 | Sichuan Yuan Da Shu Yang Pharma Co., Ltd. romanized |
| 2022/09/21New drug · Class 1 | 注射用HBT-708 · No verified English nameCXSL2200468 | Dan Sheng Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/09/21New drug · Class 1 | TQB2450注射液 · No verified English nameCXSL2200467 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2022/09/20Import · Class 2.4 | 度维利塞胶囊 · No verified English nameJXHL2200287 | Secura Bio Inc.; CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SJZ) CO. LTD. |
| 2022/09/20Import · Class 2.4 | 度维利塞胶囊 · No verified English nameJXHL2200286 | Secura Bio Inc.; CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY (SJZ) CO. LTD. |
| 2022/09/20Generic · Class 3 | 多潘立酮干混悬剂 · No verified English nameCYHS2201569 | Zhejiang Ya Tai Pharma Co., Ltd. romanized |
| 2022/09/20Generic · Class 3 | Minoxidil LinimentCYHS2201568 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/09/20Generic · Class 3 | Peramivir InjectionCYHS2201567 | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized |
| 2022/09/20Generic · Class 3 | Cytarabine InjectionCYHS2201565 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2022/09/20Generic · Class 3 | Cytarabine InjectionCYHS2201564 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2022/09/20New drug · Class 1 | 注射用XNW4107 · No verified English nameCXHL2200710 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/09/20New drug · Class 1 | 伯瑞替尼肠溶胶囊 · No verified English nameCXHL2200709 | Beijing Pu Run Ao Bio Technology Co., Ltd. romanized |
| 2022/09/20New drug · Class 1 | 伯瑞替尼肠溶胶囊 · No verified English nameCXHL2200708 | Beijing Pu Run Ao Bio Technology Co., Ltd. romanized |
| 2022/09/20New drug · Class 1 | PLB1004胶囊 · No verified English nameCXHL2200707 | Beijing An Shi Bio Technology Co., Ltd. romanized |
| 2022/09/20New drug · Class 1 | PLB1004胶囊 · No verified English nameCXHL2200706 | Beijing An Shi Bio Technology Co., Ltd. romanized |
| 2022/09/19Import · Class 1 | OMTX705注射用浓溶液 · No verified English nameJXSL2200167 | InxMed (Hong Kong) Limited; InxMed (Nanjing) Co. Ltd |
| 2022/09/19Generic · Class 3 | Digoxin InjectionCYHS2201563 | Hebei Kun An Pharma Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2022/09/19Generic · Class 3 | Doxorubicin Hydrochloride Liposome InjectionCYHS2201562 | Changzhou Wu He Biopharmaceuticals Co., Ltd. romanized; Wuxi Zi Shan Pharma Co., Ltd. romanized |
| 2022/09/19Generic · Class 3 | Doxorubicin Hydrochloride Liposome InjectionCYHS2201561 | Changzhou Wu He Biopharmaceuticals Co., Ltd. romanized; Wuxi Zi Shan Pharma Co., Ltd. romanized |
68 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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