YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 346 drug applications between 16 June 2022 and 22 June 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 50, covering 33 drug names.
2022/06/16 – 2022/06/22
- New acceptances this week
- 346
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
346filings, 50 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 195 |
| Generic | 50 |
| New drug | 42 |
| Import | 25 |
| Unspecified | 18 |
| Import re-registration | 16 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 223 |
| TCM | 55 |
| Therapeutic biologic | 55 |
| Biologic | 9 |
| Prophylactic 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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Dapoxetine Hydrochloride Tablets | 5 | 3 | 20 |
| 2 | Minoxidil Liniment | 3 | 2 | 52 |
| 3 | Venlafaxine Hydrochloride Sustained-Release Capsules | 3 | 1 | 0 |
| 4 | Tenofovir alafenamide Fumarate Tablets | 2 | 2 | 0 |
| 5 | Esmolol Hydrochloride Injection | 2 | 2 | 3 |
| 6 | Elagolix Tablets | 2 | 1 | 2 |
| 7 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 8 | Levetiracetam Tablets | 2 | 1 | 6 |
| 9 | Aminocaproic Acid Injection | 2 | 1 | 0 |
| 10 | 注射用头孢噻肟钠他唑巴坦钠 · No verified English name | 2 | 1 | 1 |
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
191 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized | 19 | 15 | 0 |
| 2 | Novo Nordisk A/S | 10 | 2 | 0 |
| 3 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 9 | 9 | 0 |
| 4 | Henan Tong Yuan Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 5 | Hubei Hua Hong Pharmaceuticals Co., Ltd. romanized | 7 | 7 | 0 |
| 6 | Janssen Research & Development LLC | 6 | 4 | 0 |
| 7 | Janssen-Cilag International NV | 6 | 2 | 0 |
| 8 | Lian Cardiovascular Limited | 5 | 1 | 0 |
| 9 | The Wellcome Foundation Limited | 5 | 1 | 0 |
| 10 | Shenzhen Shi Tian Dao Pharmaceuticals Co., Ltd. romanized | 5 | 1 | 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
78 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/06/22Import · Class 1 | Imsidolimab注射液 · No verified English nameJXSL2200093 | AnaptysBio Inc.; PPC China Corporation Limited |
| 2022/06/22Import · Class 2.4 | Setmelanotide注射液 · No verified English nameJXHL2200156 | Rhythm Pharmaceuticals; Citrine Medicine (Shanghai) Co. Ltd |
| 2022/06/22Import · Class 1 | KIN-2787片 · No verified English nameJXHL2200154 | Kinnjiu Biopharma Limited; Syneos Health (Beijing) Inc. Ltd. |
| 2022/06/22Import · Class 1 | KIN-2787片 · No verified English nameJXHL2200153 | Kinnjiu Biopharma Limited; Syneos Health (Beijing) Inc. Ltd. |
| 2022/06/22Generic · Class 3 | Tranexamic Acid InjectionCYHS2200931 | Hubei Duo Rui Pharma Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2022/06/22Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2200929 | Shaanxi Bo Sen Biopharmaceutical Shareholding Group Co., Ltd. romanized |
| 2022/06/22Generic · Class 3 | Aminocaproic Acid InjectionCYHS2200927 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2022/06/22Generic · Class 3 | Aminocaproic Acid InjectionCYHS2200926 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2022/06/22Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2200925 | Guangdong Sai Feng Pharmaceuticals Technology Co., Ltd. romanized; Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized |
| 2022/06/22New drug · Class 1 | 纳乐舒单抗注射液 · No verified English nameCXSS2200061 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized; San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2022/06/22New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSS2200060 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized; Bo Lin Ge Yin Ge Han Bio Pharma (Zhongguo) Co., Ltd. romanized |
| 2022/06/22New drug · Class 1 | JS009注射液 · No verified English nameCXSL2200285 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/06/22New drug · Class 2.2 | 醋酸阿比特龙软胶囊 · No verified English nameCXHL2200405 | Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/06/22New drug · Class 2.2 | 醋酸阿比特龙软胶囊 · No verified English nameCXHL2200404 | Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/06/22New drug · Class 1 | HRS-6209胶囊 · No verified English nameCXHL2200381 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/06/21Import · Class 2.2 | Amivantamab注射液 · No verified English nameJXSL2200092 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/06/21Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2200091 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/06/21Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2200090 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/06/21Import · Class 2.1 | Amivantamab注射液(皮下注射) · No verified English nameJXSL2200089 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/06/21Import · Class 2.4 | Lazertinib片 · No verified English nameJXHL2200157 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/06/21Generic · Class 3 | 酮洛芬凝胶贴膏 · No verified English nameCYHL2200053 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd |
| 2022/06/21Generic · Class 3 | Elagolix TabletsCYHL2200052 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2022/06/21Generic · Class 3 | Elagolix TabletsCYHL2200051 | Chengdu Brilliant Pharmaceutical Co., Ltd. |
| 2022/06/21Generic · Class 3 | Progesterone InjectionCYHL2200050 | Li Zhu Group Li Min Pharmaceutical Factory romanized |
| 2022/06/21New drug · Class 1 | 伊立珠单抗注射液 · No verified English nameCXSL2200284 | Bai Tai Bio Pharma Co., Ltd. romanized |
| 2022/06/20Import · Class 1 | 替拉扎明注射液 · No verified English nameJXHL2200140 | Raygene Inc.; Hangzhou Taibo Pharmaceutical Company Ltd. |
| 2022/06/20New drug · Class 1.1 | AC591颗粒 · No verified English nameCXZL2200029 | Jiangsu Sheng Zhong Pharmaceuticals Research Institute romanized |
| 2022/06/20New drug · Class 2.2 | 派安普利单抗注射液 · No verified English nameCXSL2200283 | Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/06/20New drug · Class 1 | CM369注射液 · No verified English nameCXSL2200282 | Beijing Tian Nuo Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/06/20New drug · Class 2.2 | 人干扰素α2b阴道泡腾胶囊 · No verified English nameCXSL2200281 | Ke Xing Biopharmaceutical Co., Ltd. romanized |
48 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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